Biostatistical Prograrmming Manager

Career Category

Job Description

Biostatistical Programming Manager

What you will do

Lets do this. Lets change the 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

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 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