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Biogen

Statistical Programming Analyst

Biogen

Statistical Programming Analyst supporting Biogen in statistical programming and data management for clinical trials. Leading deliverable creation and ensuring compliance with standards and regulations.

Posted 6/11/2026full-timeResearch Triangle Park • North Carolina • 🇺🇸 United StatesJuniorMid-Level💰 $81,000 - $105,000 per yearWebsite

Tech Stack

Tools & technologies
Unix

About the role

Key responsibilities & impact
  • Co-lead (with supervision), coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects.
  • Co-author basic 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.
  • Manage under supervision 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 SSM to ensure compliance to ESUB standards.
  • Participate in efforts to remedy departmental inefficiencies in conjunction with QPT.
  • Serve as the Statistical Programming co-lead to achieve milestones for a study; collaborates with PL and/or manager on issues or resource needs.
  • Verify program consistency and usage of data, analysis and submission standards within a study in consultation with data standards, statistical submissions management, and the data strategy plan.
  • Inform internal and external project team members of statistical programming requirements, deliverable status, and resource needs.

Requirements

What you’ll need
  • Bachelor’s degree required, Masters or PhD in Statistics or Mathematics preferred
  • 2+ years relevant work experience within an organization with a focus on data management and analysis
  • 2+ years SAS Base programming with 5+ years using SAS STAT, GRAPH and MACRO
  • 2+ years relevant industry experience
  • 2+ years clinical trial experience
  • 2+ years clinical database experience
  • CDISC and/or submissions experience
  • Some knowledge of drug development process and clinical trials
  • Some knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines
  • Some familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)
  • Some familiarity AI and ML concepts

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 ADaMstatistical programmingprogramming endpoint algorithmselectronic submissions (ESUB)data managementdata analysis
Soft Skills
coordinationcollaborationcommunicationproblem-solvingresource managementoversightreviewtimelinessefficiency improvementstatus reporting