Senior Principal Statistical Programming Lead (Remote)

Biogen; United States; Remote; USD 141,000 - 188,000; Full time

Benefits offered by this job

Medical benefits

Wellness programs

Paid time off and holidays

Stock purchase plan

Tuition reimbursement

Job summary

Biogen seeks a Senior Principal Analyst, Statistical Programming to lead programming across studies and programs, coordinating internal teams and external vendors to deliver high-quality outputs on time per ICH/GCP and Biogen standards.

You will develop ADaM specifications, support statistical analyses, and collaborate with Biostatistics to define endpoint derivations and analysis algorithms while promoting best practices across development programs.

Qualifications

• Bachelor's degree in a quantitative field is required.
• 10+ years in pharma/biotech with clinical data analysis and statistical programming.
• 10+ years SAS programming experience including Base SAS, SAS/STAT, SAS Macro, SAS Graph.
• 10+ years supporting clinical trials across multiple phases of drug development.
• 5+ years working with clinical databases and data structures.

Responsibilities

• Lead and oversee statistical programming activities across studies or programs with internal teams and vendors.
• Serve as Statistical Programming Lead for one or more clinical programs, driving milestones and addressing challenges.
• Manage programming deliverables from database build through regulatory submission, including define.xml and annotated CRFs.
• Partner with cross-functional stakeholders to communicate requirements, status, risks, and resource needs.
• Develop ADaM specifications and support analyses in collaboration with Biostatistics.
• Identify opportunities to improve programming processes, standards, and efficiencies.
• Ensure consistency and compliance with data, analysis, CDISC, and regulatory standards across studies.

Skills

Leadership

Project management

SAS programming

CDISC (SDTM/ADaM)

Regulatory submissions

Education

Bachelor's degree

Master's or PhD in Statistics/Biostatistics

Tools

SAS (Base/STAT/Macro/Graph)

R programming

Job description

Biogen seeks a Senior Principal Analyst, Statistical Programming to lead programming across studies and programs, coordinating internal teams and external vendors to deliver high-quality outputs on time per ICH/GCP and Biogen standards.

You will develop ADaM specifications, support statistical analyses, and collaborate with Biostatistics to define endpoint derivations and analysis algorithms while promoting best practices across development programs.