Senior Principal Statistical Programming Lead (Remote)

Biogen; Boston (MA); Remote; USD 141,000 - 188,000; Full time

Benefits offered by this job

Medical Insurance

Wellness programs

401(k) match

Employee stock purchase plan

Tuition reimbursement

Paid vacation time off

Parental leave

Holiday pay

Job summary

Biogen is seeking a Senior Principal Analyst in Statistical Programming to lead programming across studies and vendors, ensuring timely, high-quality outputs in line with SOPs, ICH/GCP, and regulatory requirements. This role focuses on data strategy, standardization, and collaboration with Biostatistics and cross-functional teams.

The ideal candidate has 10+ years in pharma/biotech with SAS expertise (Base, STAT, Macro, Graph), SDTM/ADaM, and experience supporting regulatory submissions and eSub

Qualifications

• Bachelor's degree in Statistics, Biostatistics, Mathematics, or related field required.
• 10+ years in pharma/biotech/CRO with clinical data analysis and statistical programming.
• 10+ years SAS programming experience: Base SAS, SAS STAT, Macro, Graph.
• 10+ years supporting clinical trials across multiple phases of drug development.
• 5+ years with clinical databases and data structures.
• CDISC SDTM and ADaM expertise and regulatory submission deliverables.
• Strong understanding of drug development lifecycle and trial processes.
• Knowledge of ICH guidelines and FDA/EMA/global health authority standards.
• UNIX/Linux environments knowledge.
• Proven leadership to manage projects and cross-functional teams.

Responsibilities

• Lead and oversee programming activities across studies and programs with vendors.
• Serve as Statistical Programming Lead for one or more programs and manage priorities.
• Manage deliverables from database build through regulatory submission (define.xml, annotated CRFs, reviewer guides).
• Collaborate with cross-functional stakeholders to communicate requirements, status, risks, and resources.
• Develop ADaM specifications and support analyses with Biostatistics for endpoint derivations.
• Identify opportunities to improve programming processes and drive best practices.
• Ensure CDISC data standards and regulatory submission compliance across studies.

Skills

Leadership

Regulatory collaboration

Cross-functional collaboration

Education

Bachelor's degree in Statistics or related field

Master's or PhD preferred

Tools

SAS

SAS Macro

SAS Graph

SAS STAT

UNIX/Linux

R

Job description

Biogen is seeking a Senior Principal Analyst in Statistical Programming to lead programming across studies and vendors, ensuring timely, high-quality outputs in line with SOPs, ICH/GCP, and regulatory requirements. This role focuses on data strategy, standardization, and collaboration with Biostatistics and cross-functional teams.

The ideal candidate has 10+ years in pharma/biotech with SAS expertise (Base, STAT, Macro, Graph), SDTM/ADaM, and experience supporting regulatory submissions and eSub