Senior Biostatistical Programming Lead

Biopharma Careers; United States; Hybrid; USD 130,000 - 140,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Job summary

Amgen seeks a Biostatistical Programming Manager to provide both strategic oversight and hands-on statistical programming support for high‑quality clinical trial deliverables. This role is part of the centrally managed QQ R Programming team and collaborates globally to meet tight timelines.

You will lead studies, ensure SDTM/ADaM data integrity, contribute to regulatory submissions, and mentor programmers while driving continuous improvement in obesity program initiatives.

Qualifications

• Doctorate or masters with relevant experience in statistical programming.
• Experience with SAS programming and regulatory submissions.
• Experience with SDTM/ADaM datasets and TFLs.
• Strong English communication skills.
• Experience in biopharma industry and obesity area preferred.

Responsibilities

• Provide rapid response statistical programming support for urgent internal and external requests.
• Lead programmers on studies and projects, including DAP activities and unblinding efforts.
• Deliver hands-on programming for SDTM, ADaM, Tables, Listings, and Figures for submissions.
• Oversee external partners per GSP Quality Oversight Plan.
• Ensure quality and timeliness of deliverables; mitigate at-risk projects.

Skills

SAS programming

R programming

Python

SDTM/ADaM

Pinnacle 21

Regulatory submission

Team leadership

Education

Doctorate degree

Master’s degree with 2 years experience

Bachelor’s degree with 4 years experience

Associate’s degree with 8 years experience

High school diploma / GED with 10 years experience

Tools

SAS Base

SAS Macro

SQL

SAS/Graph

Stat packages

Job description

Amgen seeks a Biostatistical Programming Manager to provide both strategic oversight and hands-on statistical programming support for high‑quality clinical trial deliverables. This role is part of the centrally managed QQ R Programming team and collaborates globally to meet tight timelines.

You will lead studies, ensure SDTM/ADaM data integrity, contribute to regulatory submissions, and mentor programmers while driving continuous improvement in obesity program initiatives.