Sr Principal Biostatistician, WCH

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

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 Information

The 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

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.

Biogen is an E-Verify Employer in the United States.

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.