Biostatistical Programming Manager

Role Overview

• 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

Requirements

• 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
• 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.

Tech Stack

• Python
• SQL

Benefits

• 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
• 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.