Role OverviewThe Principal Biostatistician is responsible for providing statistical analysis support for pharmaceutical research in Phase 2 and 3 clinical trials. This role involves collaborating with multi-disciplinary project teams, authoring statistical analysis plans, and providing guidance and supervision to programmers.
What You Will Do
The Principal Biostatistician will collaborate with project teams, author statistical analysis plans, contribute to publications and presentations, and provide guidance and supervision to programmers. They will also independently program or validate statistical outputs using SAS or R.
Why It Might Be a Fit
This role offers a promising career trajectory, job stability, and opportunities to influence the future of medicine and advance therapies to market. The Principal Biostatistician will have the opportunity to work with motivated, high-performance teams and receive technical training and tailored development curriculum.
Requirements
- 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 to 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
- 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
- Experience with regulatory submissions
- Engaging, fast-paced environment
- Good work-life balance
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