Description
We are seeking a highly skilled FSP Principal Biostatistician, Medical Affairs to join our team.
As a Principal Biostatistician, you will be responsible for providing statistical analysis support for pharmaceutical research in Phase 2 and 3 clinical trials.
Responsibilities:
- Collaborate with multi-disciplinary 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 execution of analysis.
- Independently program or validate statistical outputs (tables, listings and figures) using SAS or R.
- Interpret study results and review reports of study results for accuracy.
- Support exploratory analyses.
Qualifications:
- PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
- MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
- At least 3 years in Phase 2/3 clinical trial experience.
- Demonstrated ability to work proactively and independently in a fast-paced environment.
- Able to effectively communicate ideas and manage programmers in a constructive manner.
- Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary.
- Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
- Experience with CDISC, including SDTM, ADAM, CDASH.
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.