Principal Analyst, Statistical Programming

This hybrid role requires weekly presence at our offices and can be based in Durham, NC or Cambridge, MA.

The Principal Analyst, Statistical Programming leads and oversees statistical programming activities internally and with external vendors, including data standards application, production of analysis datasets, dataset specifications, tables, listings, figures, electronic submission components, and ad hoc analyses. You partner with Biostatistics to deliver high‑quality, submission‑ready statistical outputs with some supervision.

• Lead, coordinate, and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables.
• Author CDISC ADaM analysis dataset specifications, identify potential data issues or critical data examination areas.
• Work with statistics to define and document programming endpoint algorithms across a study, drug program, and/or contribute to therapeutic area level algorithms.
• Manage end‑to‑end programming of deliverables from CRF collections through electronic submission, including preparation of electronic submission components; collaborate with SMEs to ensure compliance with submission standards.
• Serve as the Statistical Programming Lead to achieve milestones for a study; collaborate 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.
• Provide input to the Portfolio Lead on overall study timelines, monitor milestones, and estimate resource needs.
• Lead a study team of statistical programmers, communicate issues to line management, and provide vendor quality oversight.
• Represent the statistical programming perspective to the study team and act as the sole functional representative.
• Help implement the Data Strategy, provide input to the Data Strategy Lead and DM lead on strategic direction, and serve as a reference for the study to the Data Sharing representative.
• Develop and implement standard programming practices and work with technical programming on tools and process improvement.

• Bachelor’s degree required;
  Master’s or PhD in Statistics or Mathematics preferred.
• 7+ years of relevant work experience in an organization focused on data management and analysis.
• 7+ years SAS Base programming and 7+ years using SAS STAT, GRAPH, and MACRO.
• 7+ years of relevant industry experience and 7+ years of clinical trial experience.
• 5+ years clinical database experience; experience with CDISC and/or submissions.
• Knowledge of drug development process, clinical trials, drug submission requirements, and ICH, FDA, EMEA, ROW guidelines.
• Familiarity with UNIX and software development packages (R, imaging and genomics software packages).
• Familiarity with AI and ML concepts.

Management

The base compensation range for this role is $ – $. Regular employees are eligible for short‑term and long‑term incentives, including cash bonuses and equity incentive opportunities, as well as a comprehensive benefits package that includes medical, dental, vision, and life insurance; fitness and wellness programs; short‑ and long‑term disability insurance; paid vacation and additional shutdown time off; paid holidays; paid days off for personal significance;

sick time; maternity and parental leave; 401(k) with company match; employee stock purchase plan; tuition reimbursement up to $10,000 per calendar year; and employee resource groups participation.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E‑Verify Employer in the United States.