Description
Data Sciences Staffing Solutions (DSSS) is a unit within IQVIA that provides sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership.
The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients.
Responsibilities:
- Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
- Perform sample 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.
- 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.
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.