About This Role:
As a Senior Principal Biostatistician, you will be at the forefront of leading study design and data analysis, providing statistical expertise for our products across various therapeutic areas. Your role is crucial in clinical development, biomarker development, research, and beyond. Acting independently, you will provide statistical input in scientific discussions, participate in protocol development, and oversee analysis plans and report specifications. You'll play a key role in reviewing 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 will report to the Director of Biostatistics, overseeing an exciting late-stage program in transplantation as well as 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 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 make you an invaluable asset.
Required Skills:
· PhD in Biostatistics or equivalent with a minimum of 5+ years 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.
Although we are open to Remote candidates, the strong preference would be to have a Hybrid presence to a Biogen office (Cambridge, MA or RTP, North Carolina).
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.
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