Sr Principal Biostatistician, WCH

Biogen•San Francisco, CA

12d•$141,000 - $188,000•Onsite

About The Position

As a Senior Principal Biostatistician, West Coast Hub (WCH), you will be part of a team working on exciting late-stage nephrology programs or new indications in early development. You will play a key role in clinical development, shaping study design and data analysis, and providing statistical expertise for the development of our products. Acting independently, you will provide statistical input in scientific discussions, participate in protocol development, and author analysis plans, specifications, and reports. You'll contribute to study setup activities, ensuring the integrity of randomization and CRFs, and leading biostatistical efforts for assigned projects. Your work involves performing statistical analyses, interpreting results, and preparing comprehensive clinical study reports. Additionally, you'll assist in preparing responses to statistical issues in regulatory or legal settings and liaise with clinical research personnel to align statistical support with our development strategy. Your contributions to process improvement initiatives and mentorship will aid in the long-term growth of our department. This position is ideally based in the Bay Area (San Francisco, CA).

Requirements

PhD in Biostatistics or equivalent
3+ years relevant work experience in the pharmaceutical/biotech industry
Understanding of statistical principles and clinical trial methodology with the ability to practice and implement them
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
Ability to manage multiple projects and conflicting priorities
Strong written and verbal communication skills; able to translate questions to meaningful and relevant statistical hypotheses and explain methodology and consequences of decisions in lay terms
Strong collaborative skills and ability to work effectively on cross-functional teams

Nice To Haves

Experience with late-stage clinical trials and/or regulatory submissions
Experience in Nephrology or immunology a plus
Detailed knowledge of R or SAS procedures and computing tools for modeling and simulations

Responsibilities

Represent biostatistics on study or project teams and provide statistical expertise and operational insight
Provide statistical support and contribute to the development of the study protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables
Define and implement statistical methodologies, conduct modeling and simulations as needed; analyze data, interpret and report results for clinical development plans
Work with statistical programmers, data management, and vendors to deliver quality data and analysis results
Collaborate closely with study or project teams for data interpretation, reporting and publication
Assist in addressing statistical issues in regulatory, legal, or other challenges
Participate in process improvement initiatives and mentor junior biostatisticians
Supervise FSP statisticians in assigned tasks

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation