Senior Principal Biostatistician - Lead Late-Stage Trials

Biopharma Careers; San Francisco (CA); On-site; USD 141,000 - 188,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Bonus & Equity

Paid vacation

Parental Leave

401(k) matching

Tuition reimbursement

Job summary

Biogen is seeking a Senior Principal Biostatistician, West Coast Hub, to lead statistical support for late-stage nephrology programs and early indications. You will shape study design, analyze data, and author analysis plans and reports, mentoring junior statisticians and guiding FSP teams.

You will liaise with cross-functional teams to ensure robust statistical input aligns with development strategy and regulatory expectations, while driving process improvements and growth within the

Qualifications

• PhD in Biostatistics or equivalent.
• 3+ years of pharma/biotech industry experience.
• Strong understanding of trial design and statistics.
• Proficiency in R, SAS, or similar software.
• Experience with regulatory submissions.
• Excellent written and verbal communication; explain statistics to non-experts.

Responsibilities

• Represent biostatistics on study or project teams and provide statistical expertise.
• Support development of study protocol, SAP, CSRs, and regulatory submissions.
• Define and implement statistical methodologies; conduct modeling and simulations.
• Collaborate with statisticians, programmers, data management, and vendors.
• Interpret data and report results for clinical development plans.
• Address regulatory/statistical issues in filings and reviews.
• Mentor junior biostatisticians and supervise FSP statisticians.

Skills

PhD in Biostatistics

3+ years pharma/biotech experience

Statistical methods & trial design

Communication of statistics to non-ex\

Regulatory guidelines familiarity

Education

PhD in Biostatistics or equivalent

Tools

R

SAS

Job description

Biogen is seeking a Senior Principal Biostatistician, West Coast Hub, to lead statistical support for late-stage nephrology programs and early indications. You will shape study design, analyze data, and author analysis plans and reports, mentoring junior statisticians and guiding FSP teams.

You will liaise with cross-functional teams to ensure robust statistical input aligns with development strategy and regulatory expectations, while driving process improvements and growth within the