Remote Senior Principal Statistical Programming Lead

Biogen; San Francisco (CA); Hybrid; USD 141,000 - 188,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Paid vacation and holidays

Parental leave

Job summary

Biogen in the United States seeks a Senior Principal Analyst, Statistical Programming to lead programming activities across studies and vendors, ensuring timely, compliant outputs in line with ICH/GCP and Biogen SOPs.

You will own ADaM specifications, support analyses with Biostatistics, and drive CDISC standards and data strategy adoption across development programs. Remote-friendly with Bay Area base.

Qualifications

• Bachelor's degree in a quantitative field required; advanced degree preferred.
• 10+ years in pharma/biotech/CRO with clinical data analysis
• 10+ years hands-on SAS programming with Base SAS
• 10+ years supporting clinical trials across phases
• 5+ years working with clinical databases and data structures
• CDISC SDTM/ADaM expertise and regulatory submission deliverables
• Strong understanding of drug development lifecycle and regulatory standards
• UNIX/Linux proficiency; leadership in cross-functional teams

Responsibilities

• Lead and oversee programming across studies and vendors to ensure timely, high-quality deliverables.
• Serve as Statistical Programming Lead for one or more clinical programs; manage milestones and resources.
• Manage deliverables from database build through regulatory submission (define.xml, annotated CRFs).
• Collaborate with cross-functional stakeholders to communicate status, risks, and needs.
• Develop ADaM specifications and support analyses with Biostatistics for endpoints and derivations.
• Identify opportunities to improve processes and drive best-practice adoption.
• Ensure consistency with CDISC standards and regulatory submission requirements.

Skills

Leadership

Project management

Cross-functional collaboration

Attention to detail

Prioritization

Communication skills

Education

Bachelor's degree

Master's degree or PhD preferred

Tools

Base SAS

SAS STAT

SAS Macro

SAS Graph

Unix/Linux

R programming

Job description

Biogen in the United States seeks a Senior Principal Analyst, Statistical Programming to lead programming activities across studies and vendors, ensuring timely, compliant outputs in line with ICH/GCP and Biogen SOPs.

You will own ADaM specifications, support analyses with Biostatistics, and drive CDISC standards and data strategy adoption across development programs. Remote-friendly with Bay Area base.