Amgen Inc

Biostatistical Prograrmming Manager

Amgen Inc • $129K — $174K *
Wilmington, DE 19805In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Doctorate degree or equivalent experience in statistical programming.
  • 6+ years of statistical programming in the biopharmaceutical industry needed.
  • Strong hands-on expertise in SAS programming, including SAS Base and Macro.
  • Experience with R programming for clinical trials is preferred.
  • Understanding of obesity clinical endpoints and related data standards is highly desirable.

Responsibilities

  • Provide rapid response programming support for urgent requests.
  • Serve as lead programmer for studies and special projects.
  • Deliver hands-on programming support for regulatory submission deliverables.
  • Oversee projects managed by FSP partners to ensure quality and compliance.
  • Mitigate at-risk projects with technical expertise and operational guidance.
  • Contribute to the development of training materials for internal teams and partners.
  • Lead GSP continuous improvement initiatives and support cross-functional projects.

Benefits

  • Opportunity for professional growth in a global team.
  • Access to innovative projects in the Obesity Therapeutic Area.
  • Engagement in continuous improvement and training initiatives.
  • Supportive environment for risk mitigation and troubleshooting.
  • Collaboration with cross-functional teams in a fast-paced setting.
Full Job Description
Career Category
Clinical
Job Description

Biostatistical Programming Manager

What you will do

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 iniatives 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
• Master's degree and 2 years of statistical programming experience OR
• Bachelor's degree and 4 years of statistical programming experience OR
• Associate's degree and 8 years of statistical programming experience OR
• High school diploma / GED and 10 years of statistical programming experience

Preferred Qualifications:
• Masters in Computer Science, 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

Salary Range
129,056.35USD -174,605.65 USD

About Amgen Inc

Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases. The company is values-based and deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious diseases. They offer products for treating illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.

Amgen Inc Careers

Join the dynamic team at Amgen Inc, a biotechnology pioneer dedicated to discovering, developing, and delivering innovative human therapeutics. At Amgen, we offer more than just job opportunities; we invite you to be part of a culture of leadership, diversity, and innovation.

Work You’ll Do

At Amgen Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that brings real solutions to patients worldwide. Our commitment to your career growth is evident in our professional development and leadership training programs designed to nurture your potential.

Innovate and Lead

Amgen Inc stands at the forefront of biotech innovation. Our team is constantly pushing the boundaries of science and technology. By joining us, you will contribute to a legacy of medical breakthroughs that improve the lives of millions.

Be Part of a Great Team

Amgen’s inclusive culture and commitment to diversity are integral to our success. We believe in empowering our employees with the skills and networking opportunities they need to thrive. Our team’s collaboration is the key to developing groundbreaking solutions.

Future-Proof Your Career

Amgen Inc offers a variety of career paths, from research and development to marketing and sales, providing near-limitless opportunities for advancement. Whether you are looking for a full-time position, an internship, or a leadership role, Amgen has a place for you. Our robust benefits package supports the well-being of our employees and their families, contributing to a fulfilling work-life balance.

Explore Job Opportunities

Discover the impact you can make with a career at Amgen Inc. We are hiring creative, curious, and motivated individuals ready to face challenges head-on. Explore our open positions that match your skills and interests.

Stay Connected

Join our team and stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. See what exciting and rewarding opportunities await.

Interview and Resume Tips

Prepare for your future with Amgen Inc by utilizing our resources designed to enhance your interview skills and polish your resume. Our hiring process is designed to identify and attract professionals who are driven to make a difference.

Amgen Inc—Where Careers Grow

At Amgen Inc, we are committed to turning innovative science into value for patients. If you are passionate about joining a team that makes a difference, search Amgen jobs today and take the first step towards a fulfilling career.

SEARCH AMGEN JOBS

READ CAREERS BLOG

JOB ALERT EMAILS

Join us at Amgen Inc, where your career can flourish in an environment of innovation, leadership, and growth.
Learn more about Amgen Inc
Size
24,200 employees
Market Cap
$141.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7.2 billion
Founded
1980
5 Year Trend
+2.5%
Revenue
$25.4 billion
NASDAQ
AMGN
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Amgen Inc

More Pharmaceuticals & Biotech Jobs

Find similar Biostatistical Prograrmming Manager jobs:

NationwideWilmington, DE