About This Role
The Principal Biostatistician is responsible for supporting study design and data analysis in clinical development. He/She supports the study level biostatistician, provides statistical input in the scientific discussion, participates in the development of study protocols including participation in study design discussions. He/She also reviews study setup activities including but not limited to randomization, CRFs and may serve as primary biostatistician at the study level. He/she develops statistical analysis plans including data and report specifications, performs statistical analyses, interprets statistical results, and co-authors clinical study reports. He/she contributes to internal decision making, publications of the clinical data, and integrated summaries for regulatory submissions. Keeps up to date on current methodology research and conducts methodology research driven by study need.
What You’ll Do
Supports the study level Biostatistician to provide statistical expertise and operational insight.
Provides statistical support in the development of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
Analyzes and communicates study level resource and quality issues that may impact deliverables or timelines. Proposes and implements solutions. Escalates issues to management as appropriate.
Explores alternative analysis methodology and data presentation techniques. Performs modeling and simulations to identify solutions for complex statistical issues.
Supports the development and implementation of standard operation procedures. Participates in process improvement initiatives.
Who You Are
You have a good understanding of statistical methods and study designs in clinical trials. You are a detail-oriented individual with a strong analytical mindset, capable of managing multiple projects simultaneously. Your proactive approach to problem-solving and your dedication to continuous learning in statistical methodologies makes you an invaluable asset.
Required Skills
PhD in Statistics/Biostatistics or equivalent.
Understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.
Ability to provide solutions to a variety of technical problems of moderate scope and complexity.
Some knowledge of medical/biological terminology and clinical trial design.
Conversant with statistical programming languages and software, including SAS and R, and computing tools for modeling and simulations.
Strong attention to detail.
General project management skills.
Effective oral and written communication skills.
Good collaborative skills and ability to work with cross-functional teams.
Additional Information
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 our DE&I efforts.
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.
Top Skills
Biogen Cambridge, Massachusetts, USA Office
225 Binney Street, Cambridge, MA, United States, 02142
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