Senior Principal Statistical Programming Lead

TalentAlly; San Francisco (CA); Remote; USD 141,000 - 188,000; Full time

Benefits offered by this job

Medical, Dental, Vision & Life ins.

401(k) with company match

_equity incentive opportunities

Tuition reimbursement

Job summary

Biogen is seeking a Senior Principal Analyst, Statistical Programming, reporting to the Head of Statistical Programming, West Coast Hub. You will lead programming across studies and vendors, ensuring timely, regulator-ready outputs in line with ICH/GCP and SOPs.

You bring 10+ years in clinical data analysis and SAS programming, strong CDISC SDTM/ADaM expertise, and a proven track record delivering submissions. Bay Area preferred; remote candidates considered for the right background.

Qualifications

• 10+ years in pharmaceutical/biotech/CRO with clinical data analysis and statistical programming.
• 10+ years hands-on SAS programming with Base SAS; 7+ years SAS STAT, Macro, and Graph.
• Experience supporting clinical trials across multiple phases of drug development.
• Demonstrated CDISC SDTM/ADaM expertise and regulatory submission deliverables.
• Working knowledge of UNIX/Linux environments.

Responsibilities

• Lead and oversee statistical programming across studies or programs, 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 milestones, managing priorities, and addressing resource challenges.
• Manage programming deliverables from database build through regulatory submission (define.xml, annotated CRFs, reviewer guides, transport files).
• Partner with cross-functional stakeholders to communicate programming requirements, status, risks, and resource needs.
• Develop ADaM specifications, support analyses, and collaborate with Biostatistics on endpoints and derivations.

Skills

Leadership

Clinical data analysis

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Unix/Linux

Vendor management

Education

Master's or PhD in Statistics/Biostatistics/related quantitative field

Bachelor's degree in a quantitative field

Tools

Define.xml

SAS Macro

SAS Graph

R programming

Job description

Biogen is seeking a Senior Principal Analyst, Statistical Programming, reporting to the Head of Statistical Programming, West Coast Hub. You will lead programming across studies and vendors, ensuring timely, regulator-ready outputs in line with ICH/GCP and SOPs.

You bring 10+ years in clinical data analysis and SAS programming, strong CDISC SDTM/ADaM expertise, and a proven track record delivering submissions. Bay Area preferred; remote candidates considered for the right background.