Principal Biostatistician

Biogen, Inc.; Cambridge (MA); On-site; USD 123,000 - 163,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Fitness reimbursement

Disability insurance

Paid vacation

Company holidays

Parental leave

401(k) with match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen, Inc. is seeking a Principal Biostatistician to lead biostatistics across products and therapeutic areas. You will shape protocol development, analysis plans, data edits, and study reports while ensuring quality and regulatory readiness. You will review analyses conducted by others and collaborate with regulatory, CROs, and external partners.

The role emphasizes leadership, rigorous statistical thinking, and the ability to drive standards across multiple projects in a global environment.

Qualifications

• PhD/MS in Biostatistics or equivalent with relevant industry experience.
• Strong understanding of statistical principles and trial design.
• Ability to provide innovative technical solutions and leadership.

Responsibilities

• Lead biostatistics for one or more drug programs and supervise study statisticians.
• Develop standards across protocols, analysis plans, and study reports.
• Review study setups (randomization, CRFs, data edits) for quality and consistency.
• Perform analyses, interpret results, and prepare clinical study reports.
• Collaborate with cross-functional teams including regulatory, CROs, and external partners.
• Contribute as CDT statistician under supervision as needed.

Skills

SAS programming

Clinical trial design

Statistical analysis

Regulatory guidelines

Leadership

Communication

Data interpretation

Education

PhD in Biostatistics/Statistics or equivalent

MS in Biostatistics/Statistics or equivalent

Job description

About This Role:

As a Principal Biostatistician, you will provide project leadership in Biostatistics for specific company products or therapeutic areas. You will play a pivotal role in developing standards across protocols, including protocol development, analysis plans, and file/report specifications. Your expertise will be crucial in reviewing study setup activities, such as randomization, CRFs, and data edits, while serving as the lead biostatistician on multiple projects. With your keen analytical skills, you will perform statistical analyses, interpret results, and prepare clinical study reports, including integrated summaries for submissions. Your role will also involve reviewing analyses performed by other study statisticians to ensure accuracy, consistency, and quality output. Additionally, you will address regulatory issues and collaborate with external development partners. As a Biostats SMT statistician, you will have the opportunity to act as a CDT statistician under supervision, contributing significantly to our mission of advancing healthcare solutions.

What You’ll Do:

Manage a moderate or large volume of complex tasks with minimal supervision across one or more drug programs. Proactively assess and adapt solutions for the Biometrics department, resolving technical issues. Make decisions at the study level across various studies, leading and prioritizing tasks globally. Collaborate closely with clinical research, regulatory affairs, CROs, Commercial, Worldwide Medical, KOLs, and other disciplines. Monitor needs and determine resources in consultation with line managers. Participate in organization-wide initiatives such as quality and standardization efforts.

Who You Are:

You are a detail-oriented and analytical individual who thrives in a collaborative environment. Your problem-solving skills enable you to navigate complex tasks with ease, and your proactive approach allows you to adapt solutions effectively. You possess strong leadership and communication skills that foster productive interactions with diverse teams. Your commitment to excellence drives you to deliver high-quality outputs, and your passion for biostatistics fuels your dedication to advancing healthcare solutions.

Required Skills:

• PhD in Biostatistics/Statistics or equivalent with 0+ years relevant industry experience
• MS in Biostatistics/Statistics or equivalent with 3+ years relevant industry experience
• Thorough understanding of statistical principles and clinical trial methodology
• Ability to provide innovative and practicable technical solutions
• Working knowledge of medical/biological terminology and clinical trial designs
• Proficiency in writing and presenting information effectively
• Conversant with SAS programming and detailed knowledge of statistical software
• Working knowledge of regulatory guidelines and needs for statistical analysis
• Demonstrated leadership and communication skills

Preferred Skills:

• Experience in global-scale task management and decision-making
• Familiarity with organization-wide initiatives such as quality and standardization
• Ability to interact with KOLs and collaborators across different disciplines

Job Level:

Management

Additional Information

The base compensation range for this role is: $123,000.00-$163,000.00 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

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.

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.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.

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.