Sr Principal Analyst, Statistical Programming
Biogen
Summary
The Senior Principal Analyst, Statistical Programming reports to the Head of Statistical Programming, West Coast Hub, and provides leadership and oversight of statistical programming activities across internal teams and external vendors at both the study and program levels. This role ensures the timely delivery of high-quality programming outputs in compliance with company SOPs, ICH/GCP guidelines, and regulatory requirements, while driving the implementation of data strategy initiatives and standardized programming practices across studies and development programs.
Job description
About This Role
The Senior Principal Analyst, Statistical Programming reports to the Head of Statistical Programming, West Coast Hub, and provides leadership and oversight of statistical programming activities across internal teams and external vendors at both the study and program levels. This role ensures the timely delivery of high-quality programming outputs in compliance with company SOPs, ICH/GCP guidelines, and regulatory requirements, while driving the implementation of data strategy initiatives and standardized programming practices across studies and development programs.
What You'll Do
- Lead and oversee statistical programming activities across studies or programs, including coordinating internal teams and external vendors to ensure timely, high-quality deliverables.
- Serve as the Statistical Programming Lead for one or more clinical programs, driving key milestones, managing priorities, and addressing resource or project challenges.
- Manage programming deliverables from database build through regulatory submission, including experience with eSub components such as define.xml, annotated CRFs, reviewer guides, and transport files.
- Partner with cross-functional stakeholders to communicate programming requirements, project status, risks, and resource needs.
- Develop ADaM specifications, support statistical analyses, and collaborate with Biostatistics to define and implement endpoint derivations and analysis algorithms.
- Identify opportunities to improve programming processes, standards, and efficiencies, and help drive adoption of best practices across teams.
- Ensure consistency and compliance with data, analysis, CDISC, and regulatory submission standards across studies and programs.
Who You Are
You love analytics and are passionate about using data to drive key business decisions. You love learning new technological skills and working through collaboration.
Required Skills
- Bachelor's degree required; Master's or PhD in Statistics, Mathematics, Biostatistics, or a related quantitative field preferred.
- 10+ years of pharmaceutical, biotechnology, or CRO industry experience with a focus on clinical data analysis and statistical programming.
- 10+ years of hands-on SAS programming experience, including extensive use of Base SAS; 7+ years utilizing SAS STAT, SAS Macro, and SAS Graph.
- 10+ years of experience supporting clinical trials across multiple phases of drug development.
- 5+ years of experience working with clinical databases and clinical data structures.
- Demonstrated expertise in CDISC standards (SDTM and ADaM) and regulatory submission deliverables.
- Strong understanding of the drug development lifecycle, clinical trial processes, and industry best practices.
- In-depth knowledge of global regulatory submission requirements, including ICH guidelines and FDA, EMA, and other international health authority standards.
- Working knowledge of UNIX/Linux environments.
- Proven leadership experience with the ability to effectively manage projects, oversee vendors, and collaborate across cross-functional teams.
- Exceptional attention to detail, organizational skills, and the ability to prioritize and manage multiple concurrent initiatives in a fast-paced environment.
Preferred Skills
- Experience with ISS/ISE development and NDA/BLA submissions
- Proficiency in R programming
- Experience working in a global regulatory environment
Requirements
- Bachelor's degree required
- Master's or PhD in Statistics, Mathematics, Biostatistics, or a related quantitative field preferred
- 10+ years of pharmaceutical, biotechnology, or CRO industry experience with a focus on clinical data analysis and statistical programming
- 10+ years of hands-on SAS programming experience, including extensive use of Base SAS
- 7+ years utilizing SAS STAT, SAS Macro, and SAS Graph
- 10+ years of experience supporting clinical trials across multiple phases of drug development
- 5+ years of experience working with clinical databases and clinical data structures
- Demonstrated expertise in CDISC standards (SDTM and ADaM) and regulatory submission deliverables
- Strong understanding of the drug development lifecycle, clinical trial processes, and industry best practices
- In-depth knowledge of global regulatory submission requirements, including ICH guidelines and FDA, EMA, and other international health authority standards
- Working knowledge of UNIX/Linux environments
- Proven leadership experience with the ability to effectively manage projects, oversee vendors, and collaborate across cross-functional teams
- Exceptional attention to detail, organizational skills, and the ability to prioritize and manage multiple concurrent initiatives in a fast-paced environment
- Experience with ISS/ISE development and NDA/BLA submissions
- Proficiency in R programming
- Experience working in a global regulatory environment
Benefits
- Medical, Dental & Vision
- Life Insurance
- Fitness & Wellness Programs
- Short- & Long-Term Disability
- 15 Days Paid Vacation
- End-of-Year Shutdown
- 12 Paid Holidays
- 80 Hours Sick Time
- Paid Maternity & Parental Leave
- 401(k) Matching
- Employee Stock Purchase Plan
- Tuition Reimbursement
- Employee Resource Groups
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.