Biostatistical Programming Manager

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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.

• 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

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.

• 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

• 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…