Senior Principal Analyst, Statistical Programming

Biogen

Senior Principal Analyst at Biogen overseeing statistical programming activities and ensuring adherence to company SOPs and ICH/GCP. Leading initiatives to implement best practices and compliance in programming operations.

Posted 4/30/2026full-timeSan Francisco • California • 🇺🇸 United StatesSenior💰 $141,000 - $188,000 per yearWebsite

Tech Stack

Tools & technologies

Unix

About the role

Key responsibilities & impact

Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of study projects via internal and/or external staff oversight
Serves as the Statistical Programming Lead to achieve milestones for a drug program which may include individual study or integrated studies; evaluates task objectives, collaborates with PL and/or manager on issues or resource needs
Manage the end-to-end programming of deliverables from CRF collections through electronic submission including preparation of electronic submissions (eSUB) components (input to reviewer’s guides, annotated CRF, define and XPTs); works with SMEs in DS&G to ensure compliance to eSUB standards
Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs
Considered a statistical programming expert within the department.
Authors CDISC ADaM (analysis data model) analysis data set specifications including the identification of potential data issues or areas of critical data examination. Works with statistics on defining and documenting programming endpoint algorithms across a study, drug program and/or contributing to TA level algorithms
Identifies process inefficiencies and lead efforts to remedy the inefficiencies and train the department on the new processes in conjunction with QPT
Verifies program consistency and usage of data, analysis and submission standards across the department in consultation with data standards, statistical submissions management and the data strategy plan
You love analytics and are passionate about using data to drive key business decisions. You love learning new technological skills and working through collaboration.

Requirements

What you’ll need

Bachelor’s degree required, Masters or PhD in Statistics or Mathematics preferred
10 years relevant work experience within an organization with a focus on data management and analysis
10+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO
10+ years relevant industry experience
10+ years clinical trial experience
5+ years clinical database experience
CDISC and submissions experience
Extensive knowledge of drug development process and clinical trials
Extensive knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines
Familiarity with UNIX
Strong management skills, and ability to effectively lead and collaborate with all functions
High attention to detail including proven ability to manage multiple, competing priorities

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

SAS Base programmingSAS STATSAS GRAPHSAS MACROCDISC ADaMdata managementdata analysisprogramming endpoint algorithmseSUB componentsclinical database management

Soft Skills

management skillscollaborationattention to detailability to manage multiple prioritiesleadershipcommunicationproblem-solvingtrainingprocess improvementresource management