FSP Principal Biostatistician, Study Powering and Design

IQVIA LLC; Durham (NC); Remote; USD 116,000 - 244,000; Full time

Benefits offered by this job

Remote work

Flexible schedule

Technical training

Career growth

Regulatory submissions

Long-term engagements

Job summary

IQVIA's Data Sciences Staffing Solutions (DSSS) is seeking a Principal Biostatistician to provide statistical support for pharmaceutical clinical trials in patients. This home-based role offers collaboration with cross-functional teams and exposure to regulatory submissions.

The candidate will perform sample size and power calculations, author SAPs, validate TLFs, and guide programmers while ensuring quality across IND/NDA activities. A PhD or MS with extensive industry experience is required.

Qualifications

• PhD in Statistics, Biostatistics, or related field with 3+ years of industry experience.
• MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
• At least 2 years in Phase 2/3 clinical trial experience.
• At least 3 years of experience in supporting simulations, sample size and power calculations
• Demonstrated ability to work pro-actively and independently.
• Able to effectively communicate statistical ideas and collaborate with cross-functional teams.
• Ability to efficiently use R or SAS to perform analyses.
• Support of various regulatory submissions.
• Understanding of relevant FDA guidance, ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
• Experience in validation/programming of ADAM and TLF.
• Experience with CDISC, including SDTM, ADAM, CDASH.
• Solid understanding of estimands and multiple imputation methods.

Responsibilities

• Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
• Perform samples size and power calculations for optimizing study design
• Author statistical analysis plans.
• Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
• Author or review analysis dataset and TLF specifications.
• Validation programming of efficacy analysis datasets plus tables, listings, and figures (TLF).
• Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures for safety, etc.
• Interpret study results and review reports of study results for accuracy.
• Support exploratory analyses.
• Participate in IND or NDA activities.
• Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
• Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, SCE (Summary of Clinical Efficacy), SCS (Summary of clinical Safety).

Skills

Statistical analysis

Cross-functional collaboration

Regulatory communication

Independent working

R or SAS

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

R

SAS

ADAM/TLF validation

CDISC (SDTM/ADAM/CDASH)

Job description

Job Level: FSP Principal Biostatistician, Study Powering and Design Location: Home-based in the U.S. or Canada

Why DSSS? Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This yields all the benefits of working for an industry leading global CRO and collaborating directly with cross-functional sponsor teams. Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market.

Job Summary: The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients.

Additional Benefits

• Home-based remote working opportunities.
• Work/life balance as well as flexible schedules.
• Collaborating with motivated, high-performance, statistical and research teams.
• Technical training and tailored development curriculum.
• Research opportunities that match your unique skillset.
• Promising career trajectory.
• Job stability: long-term engagements and re-deployment opportunities.
• Focus on bringing new therapies to market rather than project budgets and change orders.
• Experience with regulatory submissions.
• Engaging, fast-paced environment.
• Good work-life balance.

Job Responsibilities

• Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
• Perform samples size and power calculations for optimizing study design
• Author statistical analysis plans.
• Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
• Author or review analysis dataset and TLF specifications.
• Validation programming of efficacy analysis datasets plus tables, listings, and figures (TLF).
• Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures for safety, etc.
• Interpret study results and review reports of study results for accuracy.
• Support exploratory analyses.
• Participate in IND or NDA activities.
• Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
• Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, SCE (Summary of Clinical Efficacy), SCS (Summary of clinical Safety).

Qualifications (Required)

• PhD in Statistics, Biostatistics, or related field with 3+ years of industry experience.
• MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
• At least 2 years in Phase 2/3 clinical trial experience.
• At least 3 years of experience in supporting simulations, sample size and power calculations
• Demonstrated ability to work pro-actively and independently.
• Able to effectively communicate statistical ideas and collaborate with cross-functional teams.
• Ability to efficiently use R or SAS to perform analyses.
• Support of various regulatory submissions.
• Understanding of relevant FDA guidance, ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
• Experience in validation/programming of ADAM and TLF.
• Experience with CDISC, including SDTM, ADAM, CDASH.
• Solid understanding of estimands and multiple imputation methods.

Desired Experience

• Supporting written communications with regulators.
• 1+ years of experience with immunology therapeutic area.
• Bayesian methods
• #LI-Remote #LI-NITINMAHAJAN

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $115,900.00 - $243,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.