About This Role: 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).
What You'll Do:- 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
Who You Are: You are a detail-oriented individual with a strong analytical and growth mindset, capable of managing multiple projects simultaneously. Your ability to effectively communicate statistical concepts in lay terms sets you apart, alongside your leadership skills and ability to work collaboratively with diverse teams. Your proactive approach to problem-solving and your dedication to continuous learning in statistical methodologies and drug development context make you an invaluable asset.
Required Skills:- 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
Preferred Skills:- 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
Job Level: Management
Additional InformationThe base compensation range for this role is: $141,000.00-$188,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Job Level: Management
