Biostatistical Programming Manager

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

Benefits offered by this job

Competitive compensation

Flexible work models

Health, dental, vision coverage

Retirement and savings plan

Job summary

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.

Qualifications

• 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

Responsibilities

• 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

Skills

SAS programming

R programming

Python

SDTM/ADaM

GxP quality oversight

Education

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)

Tools

SAS Base

SAS Macro

SAS SQL

SAS/Graph

R

Python

Pinnacle 21

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award‑winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Biostatistical Programming Manager

What you will do

Lets do this. Lets change the world. In this vital role you will provide both strategic oversight and hands‑on statistical programming support to enable high-quality and timely clinical trial deliverables.

This role is part of the centrally managed Quality and Quick Response (QQR) Programming team and is responsible for supporting urgent and high-priority programming needs across development programs. The manager will serve as a technical programming expert who can rapidly respond to internal and external requests, support special projects, provide global quality oversight, and contribute directly to programming deliverables when needed.

This role will primarily support programs within the Obesity Therapeutic Area and requires close collaboration with cross‑functional teams to support fast‑paced development activities and evolving business priorities.

Responsibilities

• Provide rapid response statistical programming support for urgent internal and external requests
• Serve as a lead programmer for studies and projects, such as Data Access Plan (DAP) activities, unblinding efforts, and special projects
• Deliver hands‑on programming support for SDTM, ADaM, Tables, Listings, and Figures (TFLs), and other study and regulatory submission deliverables as needed
• Oversee the execution and quality of projects managed by our FSP partners per Amgen Global Statistical Programming (GSP) Quality Oversight Plan (QOP)
• Ensure that FSP and in‑house programming deliverables meet quality, compliance, timeline, and productivity expectations
• Mitigate at‑risk projects by providing technical expertise, programming support, and operational guidance
• Contribute to training material development and delivery to internal teams and FSP partners
• Provide guidance and technical consultancy to study programming team on Amgen processes, tools, and utilities
• Lead/contribute to GSP continuous improvement initiatives and support cross‑functional initiatives including inspection readiness, process improvement, innovation, and training activities
• Contribute to programming team performance metrics development, data collection, and reporting
• Review project documentation such as specifications, issue logs, deliverable status for accuracy and completeness

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a manager with these qualifications.

Basic Qualifications

• Doctorate degree OR
• Masters degree and 2 years of statistical programming experience OR
• Bachelors degree and 4 years of statistical programming experience OR
• Associates degree and 8 years of statistical programming experience OR
• High school diploma / GED and 10 years of statistical programming experience

Preferred Qualifications

• Masters in Statistics, Mathematics, Computer Science, Life Sciences or another relevant scientific subject
• 6+ years of statistical programming in biopharmaceutical industry
• Regulatory submission experience
• Strong hands‑on 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 additional programming languages and tools such as Python 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 in successful completion of all study programming activities and provide guidance on technical and process questions
• Strong understanding 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 working in a globally dispersed team on Phase 1-4 clinical trials
• Experience supporting clinical development programs within the Obesity Therapeutic Area preferred
• Understanding of obesity clinical endpoints, data standards, and regulatory considerations is highly desirable
• Excellent oral and written English communication skills; strong collaboration, negotiation, and organizational skills

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $130,000 to $140,000. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.

In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan
• Stock‑based long‑term incentives
• Award‑winning time‑off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.