Senior Biostatistical Programming Lead — Rapid Response

Amgen; Thousand Oaks (CA); Hybrid; USD 130,000 - 140,000; Full time

Job summary

Amgen is seeking a Biostatistical Programming Manager to provide strategic oversight and hands-on statistical programming support for high-priority clinical trial deliverables. You will collaborate across development programs, primarily in obesity-related areas, ensuring quality, timeliness, and regulatory readiness.

The role requires strong SAS/R/Python skills, experience with SDTM/ADaM datasets, and leadership of both in-house and external programming teams.

Qualifications

• PhD/MD/PhD-equivalent with strong statistical programming background.
• Graduate degree with relevant clinical/biostatistics focus preferred.
• Experience leading programming work for regulatory submissions is highly valued.

Responsibilities

• Provide rapid response statistical programming support for urgent requests.
• Lead programmers on studies and projects, including data access plans.
• Deliver SDTM/ADaM datasets and TFLs for regulatory submissions.
• Oversee quality and timeliness of outsourced and in-house deliverables.
• Support continuous process improvements and cross-functional training.

Skills

SAS programming

R programming

Python programming

SDTM/ADaM

Tables Listings Figures

Quality oversight

Data standards

Clinical trial analyses

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

SAS Base

SAS Macro

SQL

SAS/Graph

Stat packages

Python

Job description

Amgen is seeking a Biostatistical Programming Manager to provide strategic oversight and hands-on statistical programming support for high-priority clinical trial deliverables. You will collaborate across development programs, primarily in obesity-related areas, ensuring quality, timeliness, and regulatory readiness.

The role requires strong SAS/R/Python skills, experience with SDTM/ADaM datasets, and leadership of both in-house and external programming teams.