Biostatistical Programming Lead for High-Impact Trials

BioSpace; Washington (District of Columbia); Híbrido; USD 130.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation

Flexible work models

Health, dental, vision coverage

Retirement and savings plan

Descripción de la vacante

Amgen Biostatistical Programming Manager role located in the United States focuses on strategic leadership and hands-on programming to ensure timely clinical trial deliverables. You will oversee SDTM/ADaM work, collaborate across global teams, and support obesity program data standards and regulatory submissions.

The position demands strong SAS expertise, experience with R/Python, and leadership of in-house and outsourced programmers, with a competitive salary and comprehensive benefits.

Formación

• Doctorate degree OR Master’s with 2+ years of statistical programming experience OR Bachelor’s with 4+ years of statistical programming experience
• Associates degree with 8 years of statistical programming experience OR High school diploma with 10 years of statistical programming experience
• Strong SAS programming expertise including SAS Base, Macro, SQL, SAS/Graph and Stat packages
• Experience with R programming for clinical trial analyses, data manipulation, reporting and visualization preferred
• Familiarity with Python and other programming tools preferred
• Hands-on experience developing and validating SDTM, ADaM datasets, and TFLs
• Thorough understanding of clinical trial processes from data collection through analysis and reporting
• Ability to lead programmers and provide guidance on technical and process questions
• Knowledge of data standards and compliance checks including Pinnacle 21
• Experience providing quality oversight for outsourced and internal programming deliverables
• Ability to troubleshoot complex technical issues and turnaround at-risk projects
• Experience with globally dispersed teams on Phase 1-4 trials
• Understanding of obesity endpoints and regulatory considerations is desirable
• Excellent English communication, collaboration and organizational skills

Responsabilidades

• Provide rapid response statistical programming support for urgent internal and external requests
• Lead studies and projects, including DAP activities, unblinding, and special projects
• Deliver SDTM, ADaM, Tables, Listings, and Figures (TFLs) and other submission deliverables
• Oversee projects managed by FSP partners per GSP Quality Oversight Plan
• Ensure in-house and outsourced deliverables meet quality and timeline expectations
• Mitigate at-risk projects with technical expertise and guidance
• Contribute to training materials for internal teams and partners
• Provide guidance on Amgen processes, tools and utilities
• Lead continuous improvement initiatives across GSP and cross-functional programs
• Contribute to team performance metrics and data reporting
• Review project specifications, issue logs and deliverable status for accuracy and completeness

Conocimientos

SAS programming

R programming

Python

SDTM/ADaM

GxP quality oversight

Educación

Doctorate degree

Master's degree (2+ years experience)

Bachelor's degree (4+ years experience)

Associates degree (8+ years experience)

High school diploma (10 years experience)

Herramientas

SAS Base

SAS Macro

SAS SQL

SAS/Graph

R

Python

Pinnacle 21

Descripción del empleo

Amgen Biostatistical Programming Manager role located in the United States focuses on strategic leadership and hands-on programming to ensure timely clinical trial deliverables. You will oversee SDTM/ADaM work, collaborate across global teams, and support obesity program data standards and regulatory submissions.

The position demands strong SAS expertise, experience with R/Python, and leadership of in-house and outsourced programmers, with a competitive salary and comprehensive benefits.