Sr. Principal Analyst, Statistical Programming

Overview

This is a hybrid position that requires in-person workdays at our facilities in Durham, North Carolina.

The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internal and external vendors in the application of data standards, production of analysis datasets, data set specifications, tables, listings, figures, electronic submission components (define.xml, XPTs), and ad hoc analyses. He/She partners with Biostatistics to deliver high‑quality, submission‑ready statistical outputs. The person is responsible for providing input to the Statistical Programming Portfolio Lead on overall study timelines, monitoring and meeting agreed‑upon milestones, escalating issues, and estimating resource needs.

He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues to senior management, and ensures vendor quality oversight.

He/She represents the Statistical Programming perspective to the study team or Clinical Development Team and serves as the sole functional representative. The Senior Principal Analyst supports the implementation of the Data and Programming Strategy, works with the Data Standards team on strategic direction, partners with the PL to enforce programming standards, and provides reference for the study on data standards.

He/She develops and implements standard programming practices, and collaborates on tools and process improvements for Statistical Programming.

Leads, coordinates and manages the timely creation, oversight, review, completion and delivery of statistical programming activities and deliverables for study projects via internal and/or external staff oversight.

Authors CDISC ADaM analysis data set specifications, identifies potential data issues, and works with statistics on defining and documenting programming endpoint algorithms across studies and drug programs.

Manages end‑to‑end programming of deliverables from CRF collection to electronic submission (ESUB) components, including input to reviewer’s guides, annotated CRF, define.xml, and XPTs, and ensures compliance with eSUB standards.

Identifies process inefficiencies, leads remediation efforts, and provides training on new processes in conjunction with DVAD and PON.

Serves as Statistical Programming Lead to achieve drug program milestones, evaluates task objectives, collaborates with the PL or manager on issues or resource needs, and verifies consistent use of data, analysis and submission standards across the department.

Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs.

Senior principal analyst with strong statistical programming skills, able to lead and collaborate across functions. Pays close attention to detail and manages competing priorities.

• Bachelor’s degree required;
  Masters or PhD in Statistics or Mathematics preferred.
• 10 years relevant work experience within an organization focused 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/or 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 and software development packages (R, imaging and genomics software packages).
• Familiarity with AI and ML concepts.

Management

Base salary range: $–$

Regular employees are eligible for short‑term and long‑term incentives, including cash bonus and equity opportunities.

Full benefits include:

• Medical, dental, vision and life insurances
• Fitness and wellness programs with fitness reimbursement
• Short‑ and long‑term disability insurance
• Minimum 15 days of paid vacation plus end‑of‑year shutdown time off (Dec 26–Dec 31)
• Up to 12 company paid holidays and 3 paid days off for personal significance
• 80 hours of sick time per calendar year
• Paid maternity and parental leave benefit
• 401(k) with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement up to $10,000 per calendar year
• 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.