Sr Principal Biostatistician, WCH

Role: Senior Principal Biostatistician (West Coast Hub)

Responsibilities:
- Represent biostatistics on study/project teams; provide statistical expertise and operational insight.
- Support and contribute to study protocol, statistical analysis plan (SAP), clinical study report (CSR), and regulatory submission documents.
- Define and implement statistical methodologies; conduct modeling/simulations; analyze, interpret, and report results.
- Partner with statistical programmers, data management, and vendors to deliver quality data and analyses.
- Collaborate on data interpretation, reporting, and publication.
- Assist in addressing statistical issues in regulatory/legal or other challenges.
- Lead process improvement initiatives and mentor junior biostatisticians; supervise FSP statisticians.

Required Skills/Qualifications:
- PhD in Biostatistics (or equivalent).
- 3+ years pharmaceutical/biotech industry experience.
- Strong knowledge of statistical principles and clinical trial methodology.
- Ability to solve complex technical problems.
- Proficiency with R, SAS, or other statistical software programming languages.
- Working knowledge of regulatory guidelines for statistical analysis.
- Ability to manage multiple projects and conflicting priorities.
- Strong written/verbal communication; can explain methods and consequences in lay terms.
- Collaborative cross-functional skills.

Preferred Skills:
- Experience with late-stage trials and/or regulatory submissions.
- Experience in nephrology or immunology.
- Detailed R/SAS knowledge for modeling and simulations.

Benefits (selected):
- Medical, dental, vision, life insurance; fitness/wellness reimbursement; disability insurance.
- Paid vacation (minimum 15 days) plus end-of-year shutdown (Dec 26–Dec 31).
- 401(k) with company match; employee stock purchase plan; tuition reimbursement up to $10,000/year.