Senior Principal Analyst, Statistical Programming

Biogen

. Lead and oversee statistical programming activities across studies or programs .

Posted 10/27/2026full-timeSan Francisco • California • United StatesSenior💰 $141,000 - $188,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in statistical programming and clinical data analysis, with a strong focus on SAS programming, CDISC standards, and regulatory submission processes. Proven ability to lead cross-functional teams, manage projects, and ensure compliance with industry best practices.

Highest-signal resume keywords

SAS ProgrammingCDISC StandardsStatistical Programming LeadershipClinical Data AnalysisRegulatory Submission Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

SASBase SASSAS STATSAS MacroSAS GraphADaM SpecificationsStatistical AnalysisClinical Trial ProcessesUNIX/LinuxR Programming

Soft Skills

LeadershipAttention to DetailOrganizational SkillsProject ManagementCollaboration

Industry Keywords

PharmaceuticalBiotechnologyCROClinical TrialsRegulatory ComplianceICH GuidelinesFDA StandardsEMA StandardsNDA/BLA SubmissionsISS/ISE Development

Tech Stack

Tools & technologies

LinuxUnix

About the role

Key responsibilities & impact

Lead and oversee statistical programming activities across studies or programs
Coordinate internal teams and external vendors to ensure timely, high-quality deliverables
Serve as the Statistical Programming Lead for one or more clinical programs
Drive key milestones, manage priorities, and address resource or project challenges
Manage programming deliverables from database build through regulatory submission
Develop eSub components including 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 and support statistical analyses
Collaborate with Biostatistics to define and implement endpoint derivations and analysis algorithms
Identify opportunities to improve programming processes, standards, and efficiencies
Drive adoption of best practices across teams
Ensure consistency and compliance with data, analysis, CDISC, and regulatory submission standards

Requirements

What you’ll need

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 preferred
Proficiency in R programming preferred
Experience working in a global regulatory environment preferred

Benefits

Comp & perks

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
Short term and long-term incentives, including cash bonus and equity incentive opportunities
Remote work consideration for qualified candidates