Senior Principal Biostatistician

Biogen; Cambridge (MA); On-site; USD 138,000 - 185,000; Full time

Job summary

An established industry player is seeking a Senior Principal Biostatistician to lead innovative statistical analyses and contribute to clinical development strategies. This role involves collaborating with project teams, defining statistical methodologies, and mentoring junior staff. The ideal candidate will possess a PhD in Biostatistics or Statistics, along with extensive experience in clinical trials. Join a dynamic team committed to excellence and innovation in biotechnology, where your expertise will directly impact the delivery of life-changing medicines. Embrace a culture that values diversity, learning, and shared success.

Benefits

Health Insurance

Wellness Programs

Paid Time Off

Parental Leave

401(k)

Tuition Reimbursement

Employee Resource Groups

Stock Options

Qualifications

• PhD in Biostatistics/Statistics or equivalent; 3+ years in clinical trials.
• Strong understanding of statistical principles and clinical trial methodology.

Responsibilities

• Lead study design and data analysis in clinical development.
• Mentor junior biostatisticians and contribute to process improvements.

Skills

Statistical Principles

Clinical Trial Methodology

Problem-Solving

SAS Programming

Regulatory Guidelines

Communication Skills

Education

PhD in Biostatistics/Statistics

Tools

SAS

Job description

Job Description

About This Role

The Senior Principal Biostatistician is responsible for leading study design and data analysis, providing statistical expertise within one or more therapeutic areas in clinical development. They act as an independent SMT or RDPT Biostatistician, contribute to scientific discussions, participate in protocol development, analysis plans, and file/report specifications, and review study setup activities such as randomization and CRFs. This person performs statistical analyses, interprets results, and prepares clinical study reports, including integrated summaries for submissions. They assist in responding to statistical issues in regulatory or legal settings and maintain liaison with clinical research personnel to support development strategies. They also contribute to departmental growth through process improvements, staying current with statistical methodologies, and mentoring junior biostatisticians.

What You’ll Do

• Represent Biostatistics on Project or Study Teams; provide statistical expertise for clinical development, objectives, and strategy.
• Define statistical methodology, analyze data, report results, and assist in strategic planning; supervise contract statisticians and ensure quality of deliverables.
• Respond to statistical issues in regulatory, legal, or other challenges; may represent Biostatistics in key meetings.
• Serve as peer reviewer for material authored by other statisticians and act as an internal consultant on broad statistical issues.
• Participate in process improvement initiatives, mentor junior staff, stay updated on statistical methodologies, and conduct modeling and simulations as needed.

Qualifications

• PhD in Biostatistics/Statistics or equivalent; 3+ years relevant experience in clinical trials preferred.
• Strong understanding of statistical principles and clinical trial methodology.
• Ability to develop innovative and practical solutions to complex problems.
• Working knowledge of medical terminology, clinical trial designs, and competitive landscape in relevant therapeutic areas.
• Proficiency in SAS or other programming tools, with detailed knowledge of SAS procedures and modeling/simulation tools.
• Knowledge of regulatory guidelines and requirements for clinical trial analysis and reporting.
• Ability to manage multiple projects, adapt to changing priorities, and communicate effectively, including explaining methodologies to non-statisticians.

Additional Information

The base salary range is $138,000 - $185,000, with offers based on skills, experience, location, and internal equity. Employees are eligible for incentives, including bonuses and stock options. Biogen offers comprehensive benefits supporting physical, financial, emotional, and social well-being, such as health insurance, wellness programs, paid time off, parental leave, 401(k), tuition reimbursement, and Employee Resource Groups.

Why Biogen?

We are a global team committed to excellence and innovation. As a mid-sized biotechnology company, we offer stability, growth opportunities, and a collaborative environment focused on delivering life-changing medicines. We value diversity and inclusion, believing diverse perspectives foster innovation. Join us to make a meaningful impact, with a culture that encourages learning, growth, and shared success. Caring Deeply. Achieving Excellence. Changing Lives.

We are an equal opportunity employer, committed to an inclusive environment. Qualified applicants will receive consideration without regard to protected characteristics. Biogen is an E-Verify Employer in the United States.