Statistical Assistants

Job Title: Research Associate III

Location: Oro Valley, AZ

Hours/Schedule: Mon- Fri 40 hours

Type: Contract

Responsibilities

+ Designs a wide range of experimental protocols

+ Executes bench experiments; makes detailed observations and analyzes data.

+ Prepares technical reports, summaries and quantitative analyses.

+ Maintains complete and accurate records.

+ Normally receives general directions on routine and new assignments.

+ Identifies and implements improvements to work processes and laboratory environment.

+ Recognized expert for area of expertise.

+ Recognizes and documents activities for publication and/or patent potential

+ Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors

+ Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

+ Participates in cross functional technical teams such as a failure investigation or core team.

+ Works well in a team environment by being a productive project team member, suggesting creative solutions to problems and providing input to project planning.

+ Establishes interfaces across other organizational groups.

+ Trains others in areas of expertise

+ Troubleshoots problems and institutes corrective action.

+ Prepares and presents experimental procedures and results in group and project teams

+ Monitors work to ensure quality, and continuously promote Quality First Time.

+ Other duties as assigned by management

Requirements

+ 4 years relevant job experience

+ Bachelor's Degree in Science

+ Knows wide range of experimental techniques and skills in their applications

+ Capable with searching scientific literature to gain information about specific topics.

+ Skilled with use of word processing, spreadsheets, graphical and presentation software applications.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Job Title: Research Associate I

Location: Oro Valley, AZ

Hours/Schedule: Mon- Fri 40 hours

Type: Contract

Responsibilities

+ Characterize adjuvants, LNPs and constituent components with a variety of analytical techniques

+ Participate in/drive production of LNPs and adjuvants at lab and pilot scale

+ Provide support for execution of process development activities and manufacturing investigations

+ Perform laboratory scale studies

+ Design and troubleshoot experiments

+ Employ excellent verbal and written communication skills

+ Author laboratory notebooks and technical documents

+ Work both independently and within multidisciplinary team

+ Produce high quality work against firm deadlines

+ Maintain good sample handling practices

+ Balance and prioritize competing deliverables

Requirements

+ BS in Science, Engineering, or related field heavily preferred. Would consider AA with relevant experience.

+ Experience working with adjuvant and LNP processing a plus

+ Experience working with tangential flow filtration processing – microfiltration/ultrafiltration

+ Comfortable in a lab environment.

+ Must have scientific understanding of downstream bioprocess purification processes.

+ Scientific understanding of purification operations of large complex molecules.

+ Technical understanding of bioprocess scaling principles

+ Wet chemistry laboratory skills (pipetting, buffer preparation, filtration, dilution, stoichiometry)

+ Proficiency with technical writing and laboratory records (laboratory notebooks, chemical inventory, data management)

+ Excellent collaborative and team-working skills

+ Strong technical problem-solving abilities, data interpretation and presentation competence

+ Preferred Experience and Skills:

+ Experience working with analytical instrumentation (plate readers, densitometers, thermocyclers, cIEF, UV/Vis spectrophotometers, HPLC/ UPLC systems)

+ Experience working in GMP and GLP environments

+ Experience with laboratory operations

+ Experience working in an industry environment

+ Experience conducting laboratory scale process characterization studies

+ Experience troubleshooting technical issues (experimental, equipment-related issues)

+ Experience in method development and method transfer

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Job Title: Senior Research Associate

Location: Oro Valley, AZ

Hours/Schedule: Mon- Fri 40 hours

Type: Contract

Responsibilities

+ Designs experimental plan to support project objectives.

+ Executes bench experiments; makes detailed and general observations and analyzes data.

+ Prepares technical reports, summaries and quantitative analyses.

+ Maintains complete and accurate records.

+ Normally acts independently for developing methods, techniques and evaluation criteria for obtaining results.

+ Identifies and implements improvements to work processes and laboratory environment.

+ Recognized expert across a wide range of techniques and their application.

+ Recognizes and documents activities for publication and/or patent potential.

+ May participate in scientific conferences and contribute to scientific journals.

+ Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables.

+ Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.

+ Participates or leads cross functional technical teams such as a failure investigation or core team.

+ Works well in a team environment by being a productive project team member, suggesting creative solutions to problems and providing input to project planning.

+ Establishes interfaces across other organizational groups.

+ Trains others in areas of expertise.

+ May supervise lower level personnel and laboratory operations.

+ Troubleshoots problems and institutes corrective action.

+ Prepares and presents experimental procedures and results in group and project teams.

+ Monitors work to ensure quality, and continuously promote Quality First Time.

+ Other duties as assigned by management

Requirements

+ 4 years relevant job experience

+ Bachelor's Degree in Science

+ Knows wide range of experimental techniques and skills in their applications

+ Capable with searching scientific literature to gain information about specific topics.

+ Skilled with use of word processing, spreadsheets, graphical and presentation software applications.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Job Title: Research Associate II

Location: Oro Valley, AZ

Hours/Schedule: Mon- Fri 40 hours

Type: Contract

Responsibilities

+ Designs experimental protocols with minimal supervision

+ Executes laboratory experiments; makes detailed observations and analyzes data.

+ Prepares technical reports, summaries and quantitative analyses.

+ Maintains complete and accurate records.

+ Normally receives detailed directions on all work.

+ Makes suggestions to improve work processes.

+ Assists in reducing to practice patentable inventions.

+ Works on projects of moderate scope in which analysis of situation or data requires a review of identifiable factors.

+ Exercises judgment within defined procedures and practices to determine appropriate action.

+ May participate in cross functional technical team activities.

+ Works well in a team environment by being a productive project team member, suggesting creative solutions to problems and providing input to project planning.

+ Trains others in areas of expertise

+ Troubleshoots problems and institutes corrective action.

+ Prepares and presents experimental procedures and results in group and project teams

+ Monitors work to ensure quality, and continuously promote Quality First Time.

+ Other duties as assigned by management

Requirements

+ 2 years relevant job experience

+ Bachelor's Degree in Science

+ Knows basic and some specialized laboratory techniques.

+ Capable with searching scientific literature to gain information about specific topics.

+ Skilled with use of word processing, spreadsheets, graphical and presentation software applications.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

**Overview**

PNNL's Earth System Science Division enables energy independence and national security through leadership in earth systems science, engineering,and decision analytics. Our work focuses on solving complex problems in the dynamic Earth system. Our interdisciplinary scientists steward a breadth of efforts that encompass research on plants to groundwater science and coastal zones, to storm prediction.

Our research focuses on understanding and mitigating operational risks at the interface of human and natural environments. This includes predicting the impacts of natural hazards and extreme climate events on Earth and human systems, along with the impacts of wildfire, flooding, sea level rise and storm surges. We focus on understanding and mitigating environmental contamination and increasing the resiliency, security and sustainability of water resources. We provide geointelligence through advanced sensing and data analytics to forecast complex system behaviors and operational performance to understand human-natural systems. This includes informed decision making and enhanced community resilience, advanced monitoring, and remote sensing of environmental systems for energy and national security. It also includes developing energy systems, including geothermal energy, sustainable oil and gas production, storage and utilization, along with carbon sequestration.

Driven by a “science-to-solutions” philosophy, we provide scientific leadership and technology to enhance national security, mitigate natural hazards and optimize disaster response. In the critical areas of energy, environment, intelligence, and defense, we deliver insights and decision support through the development of tools and solutions.

**Responsibilities**

If you are a talented geophysicist and you want to join a highly dynamic team working in various application domains,this job is for you. The Geophysics & Geomechanics Team within the Subsurface Science & Technology Group is seeking a seismologist who can contribute to research in geothermal energy, environmental remediation monitoring, and underground nuclear detonation detection.

Discipline, principal job duties/expectations, and qualitative and quantitative measures of performance that exceed the Functional Descriptor:

+ Publishing in leading peer-reviewed journals.

+ Present research efforts and technical work products at project meetings and national forums

+ Close collaboration with the team and external collaborators.

**Qualifications**

Minimum Qualifications:

+ Candidates must have received a PhD within the past five years (60 months) or within the next 8 months from an accredited college or university.

Preferred Qualifications:

+ Demonstrated expertise in geophysics, seismological methods, field work, and data processing.

+ Proficiency with programming/scripting in MatLab, Python, Julia, C++, Linux/Unix environments as well as standard office software.

+ Familiarity with Distributed Fiber Optic Sensing (DAS, DTS, DSS).

+ Strong verbal and written communication skills

**Hazardous Working Conditions/Environment**

This position is office based with opportunities to work in laboratory and field. As such, travel to offsite locations may be required. Lab and field work conditions may include radiological, chemical, biological, and munitions hazards. Exposure to mechanical hazards, chemicals, etc., are kept to a minimum and mitigated using administrative and engineering controls, and the maintenance of a safety-conscious work environment.

**Additional Information**

Not Applicable.

**Testing Designated Position**

Not a Testing Designated Position.

**About PNNL**

Pacific Northwest National Laboratory (PNNL) is a world-class research institution powered by a highly educated, diverse workforce committed to the values of Integrity, Creativity, Collaboration, Impact, and Courage. Every year, scores of dynamic, driven people come to PNNL to work with renowned researchers on meaningful science, innovations and outcomes for the U.S. Department of Energy and other sponsors; here is your chance to be one of them!

At PNNL, you will find an exciting research environment and excellent benefits including health insurance, and flexible work schedules. PNNL is located in eastern Washington State—the dry side of Washington known for its stellar outdoor recreation and affordable cost of living. The Lab’s campus is only a 45-minute flight (or ~3 hour drive) from Seattle or Portland, and is serviced by the convenient PSC airport, connected to 8 major hubs.

**Commitment to Excellence and Equal Employment Opportunity**

Our laboratory is committed to fostering a work environment where all individuals are treated with fairness and respect while solving critical challenges in fundamental sciences, national security, and energy resiliency. We are an Equal Employment Opportunity employer.

Pacific Northwest National Laboratory considers all applicants for employment without regard to race, religion, color, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information (including family medical history), protected veteran status, and any other status or characteristic protected by federal, state, and/or local laws.

We are committed to providing reasonable accommodations for individuals with disabilities and disabled veterans in our job application procedures and in employment. If you need assistance or an accommodation due to a disability, contact us at [email protected] .

**Drug Free Workplace**

PNNL is committed to a drug-free workplace supported by Workplace Substance Abuse Program (WSAP) and complies with federal laws prohibiting the possession and use of illegal drugs.

If you are offered employment at PNNL, you must pass a drug test prior to commencing employment. PNNL complies with federal law regarding illegal drug use. Under federal law, marijuana remains an illegal drug. If you test positive for any illegal controlled substance, including marijuana, your offer of employment will be withdrawn.

**Security, Credentialing, and Eligibility Requirements**

In accordance with Homeland Security Presidential Directive 12 (HSPD-12) and Department of Energy (DOE) Order 473.1A, new employees are required to obtain and maintain a HSPD-12 Personal Identity Verification (PIV) Credential. To obtain this credential, new employees must successfully complete and pass a Federal Tier 1 background check investigation. This investigation includes a declaration of illegal drug activities, including use, supply, possession, or manufacture within the last year. This includes marijuana and cannabis derivatives, which are still considered illegal under federal law, regardless of state laws.

For foreign national candidates:

If you have not resided in the U.S. for three consecutive years, you are not eligible for the PIV credential and instead will need to obtain a favorable Local Site Specific Only (LSSO)risk determination to maintain employment. Once you meet the three-year residency requirement, you will be required to obtain a PIV credential to maintain employment.

**Mandatory Requirements**

Please be aware that the Department of Energy (DOE) prohibits DOE employees and contractors from having any affiliation with the foreign government of a country DOE has identified as a “country of risk” without explicit approval by DOE and Battelle. If you are offered a position at PNNL and currently have any affiliation with the government of one of these countries, you will be required to disclose this information and recuse yourself of that affiliation or receive approval from DOE and Battelle prior to your first day of employment.

**Rockstar Rewards**

Employees and their families are offered medical insurance, dental insurance, vision insurance, health savings account, flexible spending accounts, basic life insurance, disability insurance*, employee assistance program, business travel insurance, tuition assistance, supplemental parental bonding leave**, surrogacy and adoption assistance, and fertility support. Employees are automatically enrolled in our company funded pension plan* and may enroll in our 401k savings plan. Employees may accrue up to 120 vacation hours per year and may receive ten paid holidays per year.

* Research Associates excluded.

**Once eligibility requirements are met.

Click Here For Rockstar Rewards (https://careers.pnnl.gov/rockstar-rewards)

**Notice to Applicants**

PNNL lists the full pay range for the position in the job posting. Starting pay is calculated from the minimum of the pay range and actual placement in the range is determined based on an individual’s relevant job-related skills, qualifications, and experience. This approach is applicable to all positions, with the exception of positions governed by collective bargaining agreements and certain limited-term positions which have specific pay rules.

As part of our commitment to fair compensation practices, we do not ask for or consider current or past salaries in making compensation offers at hire. Instead, our compensation offers are determined by the specific requirements of the position, prevailing market trends, applicable collective bargaining agreements, pay equity for the position type, and individual qualifications and skills relevant to the performance of the position.

**Minimum Salary**

USD $69,000.00/Yr.

**Maximum Salary**

USD $119,100.00/Yr.

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology - it is all we do - combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking - we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients. Position Summary: The TD2 Research Associate - In Vitro Pharmacology is involved in many aspects of the lab's operations including tissue culture activities, various cell-based assays, and works in collaboration with Vivarium staff to support experiments involving small animals. The candidate should be able to independently work in a deadline-driven environment. Essential Functions: * Responsible for planning and procuring necessary resources for tissue culture activities, ensuring timely execution, availability of reagents and media, and adherence to experimental timelines and quality standards. * Works closely with laboratory management to support daily team activity scheduling and planning. * Executes in vitro and in vivo pharmacology studies as assigned, with minimal supervision. * Supports laboratory management in training and mentoring activities. * Provides technical input on protocol execution. * Ensures the quality and integrity of the tissue culture banks. * Supports additional laboratory techniques including but not limited to Western Blots, Elisa, or qPCR. * Maintains detailed laboratory files and documents. * Participate in weekly lab meetings by updating the department of progress, results, and future studies. * Ensure laboratory equipment records are up to date and provides assistance as needed to confirm maintenance or service are completed. * Performs general laboratory duties. * Assists in other laboratory duties as assigned. Job Requirements: * A minimum of a Bachelor's degree with 2-3 years direct in vitro pharmacology experience. Relevant laboratory experience may be substituted at TD2's discretion. * Experience in tissue culture techniques and other in vitro cell based assays is required. * Immunology assays experience is preferred. Required Specialized/Technical Skills: * Strong computer skills, including proficiency in the use of Microsoft applications and data analysis software. * Periodic weekend/holiday shifts. * Strong attention to detail. * Highly organized. TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran's status, gender, sexual orientation, gender identity, or gender expression. #LI-TD2

**Who Are You?**

As a Principal Statistician, you will be dedicated to one of our major Pharma clients, working as an extension of their staff to lead and support clinical trials for drug development, with the opportunity to leverage your experience in late-phase trials and regulatory submissions for Gastrointestinal studies.

**Sponsor-dedicated:**

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

**Position Overview:**

Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.

**As a Principal Biostatistician, your responsibilities will include:**

+ Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors.

+ Lead statistical teams on clinical development projects, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across clinical trials of each assigned project.

+ Provide statistical input into study protocols, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.

+ Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.

+ When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.

+ Contribute to the development of sourcing strategy for projects.

+ Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

**Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:**

+ Master’s degree in statistics or a related discipline. Ph.D. strongly desired.

+ 6+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.

+ At least 3 years of recent experience on late-phase (II & III) drug development including drafting SAPs/calculating sample size/reviewing TLFs

+ When in the lead role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.

+ Experience in Gastro-intestinal studies or submission is a plus

+ Strong knowledge of pharmaceutical industry and regulatory environment preferred

+ Strong SAS and/or R programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.

+ Ability to work independently, demonstrate initiative and flexibility through effective and innovative leadership.

+ Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviors

+ Team player: willingness to go the extra distance to get results, meet deadlines, etc.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

**Who Are You?**

As a Senior Statistician, you will be dedicated to one of our major Pharma clients, working as an extension of their staff to support or lead clinical trials for drug development, with the opportunity to leverage your experience in all phase's trials and regulatory submissions for Gastrointestinal studies.

**Sponsor-dedicated:**

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

**Position Overview:**

Our Senior Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.

**As a Senior Biostatistician, your responsibilities may include:**

+ Providing statistical support to clinical studies

+ Participating in the development of study protocols, including participation in study design discussions and sample size calculations

+ Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications

+ Performing statistical analyses and interpreting statistical results

+ Preparing clinical study reports, including integrated summaries for submissions

+ Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.

+ Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.

+ Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros

+ Participate in the development of CRFs, edit check specifications, and data validation plans

+ Provide review and/or author data transfer specifications for external vendor data

+ Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals

**Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:**

+ Master’s degree in statistics or a related discipline. Ph.D. strongly desired.

+ 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.

+ At least 3 years of recent experience on late-phase (II & III) drug development including drafting SAPs/calculating sample size/reviewing TLFs.

+ Experience in Gastro-intestinal studies or submission is a plus.

+ Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is a plus.

+ Strong knowledge of full clinical trial process with experience writing SAPs, reviewing and verifying key statistical outputs

+ Solid understanding & implementation of CDISC requirements for regulatory submissions.

+ Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviors

+ Team player; willingness to go the extra distance to get results, meet deadlines, etc.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

As Medical Affairs Biostatistician, you are responsible for statistical activities in support of Medical Affairs, including contributing to post approval study designs, study protocol and analysis plan development, reviewing and interpreting the analysis of study data, and conducting ad hoc and exploratory analyses.

**As a Principal Biostatistician, Medical Affairs, your responsibilities include:**

+ Collaborates with Medical Affairs (Medical Research and Value, Evidence & Strategy), Medical Communications and Publications, Epidemiology and Regulatory to design post approval studies.

+ Writes the statistical sections of study protocols, while consulting with internal and external experts.

+ Contributes to or prepares statistical analysis plans.

+ Collaborates with Data Management and Medical Research on design of eCRFs.

+ Provides statistical guidance on conduct of ongoing studies.

+ Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs

+ Contributes observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.

+ Contributes to scientific articles, summarizing data collected in studies.

+ Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed.

+ Reviews abstracts, manuscripts for publications and presentations.

**What we’re looking for:**

+ PhD in Biostatistics, Statistics, or equivalent with at least 3 years pharmaceutical biostatistics experience; or MS with at least 5 years’ relevant experience.

+ Excellent written and oral communication and presentation skills.

+ Extensive experience programming in SAS.

+ Extensive experiences working on data analysis with clinical studies database

+ Experience working on post-approval observational and clinical studies.

+ Understanding of ICH GCP as well as general knowledge of industry practices and standards.

+ Experiences in R programming language and other statistical software.

+ Experience with CDISC, including SDTM, ADaM, CDASH.

Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel’s scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value and unlock the full potential of their data.

Come be a part of a team where talent, experience and scientific rigor come together to advance the state of clinical development. As the industry's largest provider of statistical software and advanced analytics, Cytel is home to some of the most innovative, collaborative and rigorous biostatistics, statistical programming and data management talent. Cytel careers offer meaningful work and stimulating challenges within a welcoming and diverse global culture.

Whether your specialty is biostatistics, statistical programming, adaptive clinical trial design, clinical data management, Bayesian statistics, real-world evidence, artificial intelligence, health economics, or a corporate function, you will be growing an exciting career while contributing to advancing the future of human health at Cytel. Search our open jobs or get in touch today to find your fit!

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

**Who Are You?**

As a Principal Statistician, you will be dedicated to one of our major Pharma clients, working as an extension of their staff to lead and support clinical trials for drug development, with the opportunity to leverage your experience in late-phase trials and regulatory submissions for Gastrointestinal studies.

**Sponsor-dedicated:**

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

**Position Overview:**

Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.

**As a Principal Biostatistician, your responsibilities will include:**

+ Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors.

+ Lead statistical teams on clinical development projects, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across clinical trials of each assigned project.

+ Provide statistical input into study protocols, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.

+ Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.

+ When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.

+ Contribute to the development of sourcing strategy for projects.

+ Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

**Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:**

+ Master’s degree in statistics or a related discipline. Ph.D. strongly desired.

+ 6+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.

+ At least 3 years of recent experience on late-phase (II & III) drug development including drafting SAPs/calculating sample size/reviewing TLFs

+ When in the lead role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.

+ Experience in Gastro-intestinal studies or submission is a plus

+ Strong knowledge of pharmaceutical industry and regulatory environment preferred

+ Strong SAS and/or R programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.