Lead Biostatistical Programmer (Global Trials)

BioSpace; Washington (District of Columbia); On-site; USD 130,000 - 140,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Flexible work models

Job summary

Amgen is seeking a Biostatistical Programming Manager to provide strategic oversight and hands-on support for clinical trial deliverables. You will lead programming efforts across studies, manage data access plans, and contribute to SDTM/ADaM deliverables for regulatory submissions.

Role requires extensive SAS expertise, familiarity with R/Python, and the ability to guide cross-functional teams and external partners to ensure quality and timely results.

Qualifications

• Advanced degree requirements as listed (PhD/Masters with programming experience or equivalent).
• Strong SAS programming expertise and experience with SDTM/ADaM data structures.
• Experience with R and Python for clinical trial analyses is preferred.
• Ability to lead programmers and provide technical guidance on processes.

Responsibilities

• Provide strategic oversight and hands-on statistical programming for clinical trials.
• Lead studies, handle data access plans, unblinding, and special projects.
• Deliver SDTM/ADaM tables, listings, and figures for regulatory submissions.
• Oversee outsourcing partners and ensure quality, timeline, and productivity.
• Contribute to training materials and cross-functional process improvements.

Skills

Leadership

Communication

Project management

Cross-functional collaboration

Quality oversight

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma

Tools

SAS programming (Base, Macro, SQL, SAS/Graph)

R programming

Python

SDTM/ADaM datasets

Regulatory submission tooling

Job description

Amgen is seeking a Biostatistical Programming Manager to provide strategic oversight and hands-on support for clinical trial deliverables. You will lead programming efforts across studies, manage data access plans, and contribute to SDTM/ADaM deliverables for regulatory submissions.

Role requires extensive SAS expertise, familiarity with R/Python, and the ability to guide cross-functional teams and external partners to ensure quality and timely results.