Biostatistical Prograrmming Manager

Biostatistical Programming Manager

What you will do

Let’s do this. Let’s 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 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