Responsibilities:
- Contribute to statistical design and analysis of early- and late-phase clinical studies.
- Apply advanced statistical methods and data visualization to clinical summaries and interpretations, including integrated safety/efficacy analyses for regulatory submissions.
- Serve as biostatistics representative on cross-functional teams; align statistical approaches with study/program objectives.
- Provide input on study design, endpoint selection, and sample size planning.
- Draft Statistical Analysis Plans (SAPs) and support interpretation of results.
- Ensure quality/accuracy of statistical deliverables by independently producing and/or validating outputs from CROs or internal programming teams.
- Manage CROs and mentor junior staff/contractors.
Qualifications:
- Ph.D. in Biostatistics with 6+ years industry experience, or Master’s with 8+ years.
- Study statistician experience on global Phase III trials (ideally immunology/immune-mediated diseases).
- Track record supporting regulatory submissions (NDA/BLA/MAA), including integrated safety/efficacy analyses.
- Hands-on sponsor experience in biotech/pharma (not only CRO/site/academic).
- Ability to manage CROs and statistical programming teams in a sponsor setting.
- Strong foundation in clinical trial design, statistical analysis, and regulatory guidelines.
- Proficiency in SAS and R.
- Publication and/or real-world data experience preferred.
Skills:
- Strong analytical thinking and attention to detail.
- Excellent written/verbal communication; ability to influence without authority.
- Independent work in a fast-paced, regulated environment; strong organization and workflow management.