Sr Principal Analyst, Statistical Programming

Biogen•San Francisco, CA

1d•$141,000 - $188,250•Remote

About The Position

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 the study and program levels. The role ensures timely, high-quality programming outputs that comply with company SOPs, ICH/GCP guidelines, and regulatory requirements, while advancing data strategy initiatives and standardized programming practices across studies and development programs. The position serves as Statistical Programming Lead for one or more clinical programs and manages programming deliverables from database build through regulatory submission. It partners with cross-functional stakeholders and Biostatistics, develops ADaM specifications, supports statistical analyses, and helps ensure consistency with data, analysis, CDISC, and regulatory submission standards. The role is ideally based in the Bay Area (San Francisco, CA), but remote candidates may be considered.

Requirements

Bachelor's degree required.
10+ years of pharmaceutical, biotechnology, or CRO industry experience focused 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.
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.
Leadership experience with the ability to manage projects, oversee vendors, and collaborate across cross-functional teams.
Exceptional attention to detail and organizational skills, with the ability to prioritize and manage multiple concurrent initiatives in a fast-paced environment.

Nice To Haves

Master's or PhD in Statistics, Mathematics, Biostatistics, or a related quantitative field.
Experience with ISS/ISE development and NDA/BLA submissions.
Proficiency in R programming.
Experience working in a global regulatory environment.

Responsibilities

Lead and oversee statistical programming activities across studies or programs, coordinating internal teams and external vendors to ensure timely, high-quality deliverables.
Serve as Statistical Programming Lead for one or more clinical programs, driving milestones, managing priorities, and addressing resource or project challenges.
Manage programming deliverables from database build through regulatory submission, including 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.
Ensure consistency and compliance with data, analysis, CDISC, and regulatory submission standards across studies and programs.

Benefits

Medical, dental, vision, and life insurance.
Fitness and wellness programs, including fitness reimbursement.
Short- and long-term disability insurance.
At least 15 days of paid vacation and additional end-of-year shutdown time off (December 26–31).
Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
80 hours of sick time per calendar year.
Paid maternity and parental leave.
401(k) program with company-matched contributions.
Employee stock purchase plan.
Tuition reimbursement of up to $10,000 per calendar year.
Employee Resource Groups participation.
Short-term and long-term incentives, including cash bonus and equity incentive opportunities.