Associate Director, Biostatistics

Overview

Biogen’s West Coast Hub, based in South San Francisco, focuses on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. We are seeking top talent to join us on this journey.

About This Role

As Associate Director, Biostatistics, you will lead study design and data analysis, providing statistical expertise for products across various therapeutic areas. Your role is crucial in clinical development, biomarker development, research, and beyond. You will act independently, provide statistical input in scientific discussions, participate in protocol development, and oversee analysis plans and report specifications. You will review study setup activities to ensure the integrity of randomization and CRFs, and lead biostatistical efforts for assigned projects.

Your work includes performing statistical analyses, interpreting results, and preparing comprehensive clinical study reports. Additionally, you will 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. You will contribute to process improvement initiatives and mentorship for long-term department growth. This position reports to the Head of Biostatistics for Biogen's West Coast Hub and contributes to late-stage programs in nephrology or new indications in early development.

What You’ll Do

• Lead biostatistics representation on project or study teams and provide statistical expertise.
• Define statistical methodologies, analyze data, and report results for clinical development plans.
• Train and supervise contract statisticians, ensuring quality deliverables.
• Assist in addressing statistical issues in regulatory, legal, or other challenges.
• Serve as a peer reviewer and internal consultant on broad statistical issues.
• Participate in process improvement initiatives and mentor new/junior biostatisticians.
• Conduct modeling and simulations as needed.
• Collaborate closely with study or project teams for data interpretation and reporting.
• Work with statistical programmers, data management, and vendors to deliver analysis results.
• Collaborate with medical writers to complete study reports and manuscripts.
• Supervise FSP statisticians in assigned tasks.

Who You Are

You are a detail-oriented individual with a strong analytical mindset, capable of managing multiple projects simultaneously. Your ability to effectively communicate complex statistical concepts in lay terms, along with leadership skills and ability to work with diverse teams, sets you apart. A proactive approach to problem solving and a dedication to continuous learning in statistical methodologies make you an invaluable asset.

Required Skills

• PhD in Biostatistics or equivalent with a minimum of 6+ years of relevant work experience in the pharmaceutical/biotech industry.
• Thorough understanding of statistical principles and clinical trial methodology.
• 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.
• Strong ability to manage multiple projects and conflicting priorities.
• Excellent written and verbal communication skills.

Preferred Skills

• Experience with statistical components of regulatory submissions.
• Detailed knowledge of R or SAS procedures and computing tools for modeling and simulations.
• Proven experience in mentoring junior staff and contributing to process improvements.

Job Level: Management

Additional Information

The base compensation range for this role is: $-$

The 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 achievements and recognize future potential based on individual, business unit and company…