Amgen Biostatistical Programming Manager in Uxbridge, United Kingdom

Biostatistical Programming Manager - Technical Manager

The company:

Amgen is one of the world's largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.

The Team:

The successful candidate will be part of a Global Statistical Programming team ensuring projects outsourced to Functional Services Provider (FSP) are aligned to priorities and meet Amgen timeline, quality, data standards and compliance expectations.

The Role:

As a Biostatistical Programming Manager - Technical Manager , you will ensure that projects outsourced to our Functional Service Providers (FSPs) are aligned with our priorities and meet Amgen timeline, quality, data standards and compliance expectations. You will also provide technical consultancy to our FSPs on Amgen processes, tools and utilities.

Responsibilities

  • Aligning FSP assignments with Amgen Development priorities

  • Providing estimation of project resource needs

  • Ensuring FSP programming meets quality, compliance, timeline, and productivity expectations

  • Ensuring FSP adherence to Amgen Policies, SOPs and other controlled documents as per Scope of Work

  • Contributing to FSP training material development and revisions, and conducting the initial training to FSP staff

  • Providing guidance to FSP Study Lead Programmers (SLP) on GSP processes, tools, and utilities

  • Contributing to FSP performance metrics data collection and reporting Key Project Responsibilities:

  • Align with Statistician, Product Lead Programmer, and FSP Study Lead Programmer on project priority, timelines, deliverables, quality oversight plan, and data standards

  • Conduct kickoff meeting with FSP staff for each outsourced project

  • Meet regularly with FSP SLP to assess project progress and help address project level operational issues

  • Collaborate with Amgen Statistician to develop the Project Delivery Plan for FSP deliverables and implement the plan

  • Routinely review project documentations such as issue logs, deliverable status, and Statistical Project Plan (SPP); follow up with FSP SLP on concerns or questions

  • Throughout project conduct and shortly before key milestones, verify adherence to GSP-wide and product-level standards

  • Represent Amgen in audits and determine responses to audit questions and findings

  • Maintain resource estimate for the outsourced project during Amgen's demand review cycle and update the estimate as a result of significant milestone or scope changes on the project

  • Capture specific issues leading to rework or timeline delays during the execution of the project

  • Provide technical consultancy to FSP SLP on functional and product-level processes and tools

  • Advise FSP SLP on study-specific questions for specifications, documentation, and coding Key Management Responsibilities:

  • Monitor and report on the performance of the FSP operating model; make recommendations for refining the model

  • Monitor and report on FSP performance, including metrics and adherence to service level agreements around quality, compliance, productivity, and timeliness of deliverables

  • Contribute to FSP training material development and provide initial training to FSP

Basic Qualifications:

  • Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject

  • Extensive statistical experience in biopharmaceutical industry

  • Thorough understanding of clinical trial processes from data collection to analysis reporting

  • Ability to lead programmers in successful completion of all study programming activities and provide guidance on technical and process questions

  • Experience working in a globally dispersed team on Phase 1-4 clinical trials

  • Excellent oral and written English communication skills; strong negotiation skills

  • Advanced SAS analysis and reporting skills including SAS Base, macro, and SQL

  • Hands-on experience in specifying and implementing SDTM and ADaM data sets, and TFLs

  • Ability to define and implement an effective standardization strategy for a product following the latest CDISC SDTM, ADaM and define standards

Preferred Skills:

  • Regulatory submission experience

  • Vendor and resource management experience

  • Familiarity with other programming languages such as R or Python

  • In-depth knowledge of SAS/Graph and Stat packages

Location: Uxbridge

Remuneration: Competitive salary & comprehensive benefits package including bonus scheme