Sr. Principal Biostatistician
$134,000–$179,000 year
RemoteUnited States
Job Summary
Lead biostatistics representation on project teams by defining methodologies, analyzing data, and reporting results for clinical development plans. Oversee analysis plans, review study setup activities for randomization and CRF integrity, and conduct modeling and simulations as needed. Train and supervise contract and FSP statisticians to ensure quality deliverables while collaborating with programmers, data management, and vendors to interpret findings. Assist in addressing statistical issues for regulatory, legal, or other challenges and prepare responses accordingly. Prepare comprehensive clinical study reports and manuscripts in coordination with medical writers. Serve as a peer reviewer and internal consultant on broad statistical issues while contributing to process improvement initiatives.
Required Qualifications
- PhD in Biostatistics or equivalent
- Minimum of 3+ years relevant work experience in the pharmaceutical/biotech industry
- Thorough understanding of statistical principles and clinical trial methodology
- Ability to provide technical solutions to a wide range of difficult problems
- Conversant with R, SAS, or other statistical software programming languages
- Working knowledge of regulatory guidelines related to statistical analysis
- Strong ability to manage multiple projects and conflicting priorities
- Excellent written and verbal communication skills
- Hybrid presence to a Biogen office (Cambridge, MA or RTP, North Carolina)
Desired Qualifications
- Experience with statistical components of regulatory submissions
- Detailed knowledge of R or SAS procedures and computing tools for modeling and simulations
- Proven experience in mentoring junior staff and contributing to process improvements
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