FSP Principal Biostatistician, Medical Affairs
About The Position
The Principal Biostatistician provides statistical analysis support for pharmaceutical research in Phase 2 and Phase 3 clinical trials. This role is part of IQVIA’s Data Sciences Staffing Solutions (DSSS), which provides embedded resources through Functional Service Provider partnerships and involves collaboration with sponsor teams. The position is home-based in the U.S. or Canada. The Principal Biostatistician works with multidisciplinary teams, develops statistical analysis plans, provides statistical expertise, guides programmers, programs or validates statistical outputs, interprets study results, reviews study reports, and supports exploratory analyses. The role also contributes to publications and presentations.
Requirements
- PhD in Statistics, Biostatistics, or a related field with 5 or more years of industry experience, or an MS in Statistics, Biostatistics, or a related field with 7 or more years of industry experience.
- At least 3 years of Phase 2/3 clinical trial experience.
- Ability to work proactively and independently in a fast-paced environment.
- Ability to communicate ideas effectively and manage programmers constructively.
- Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary.
- Understanding of ICH GCP and ICH E9, plus general knowledge of industry practices and standards.
- Experience with CDISC, including SDTM, ADaM, and CDASH.
Nice To Haves
- Experience contributing to peer-reviewed publications and presentations.
Responsibilities
- Collaborate with multidisciplinary project teams to establish project objectives and timelines.
- Author statistical analysis plans.
- Collaborate with Biostatistics, Statistical Programming, Clinical Development, and Clinical Operations to provide statistical expertise.
- Contribute to publications and presentations.
- Provide guidance and supervision to programmers in planning and executing analyses.
- Independently program or validate statistical outputs, including tables, listings, and figures, using SAS or R.
- Interpret study results and review reports of study results for accuracy.
- Support exploratory analyses.
Benefits
- Home-based remote working opportunities.
- Flexible schedules and work/life balance.
- Collaboration with motivated, high-performance statistical and research teams.
- Technical training and a tailored development curriculum.
- Research opportunities matched to the employee’s skillset.
- Promising career trajectory.
- Job stability through long-term engagements and redeployment opportunities.
- Experience with regulatory submissions.
- Engaging, fast-paced environment.
- Health and welfare benefits may be offered, depending on the position.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
