Biostatistical Programming Manager - Technical Manager
Amgen Global Statistical Programming team is looking for an experienced Programming Manager who will be responsible the oversight of our Functional Services provider (FSP) focusing on operational excellence and delivering projects on time within agreed scope.
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Our Statistical Programming Team :
The successful candidate will be part of a Global Statistical Programming team ensuring projects outsourced to Functional Services Provider are aligned to priorities and meet Amgen timeline, quality, data standards and compliance expectations.
Biostatistical Programming Manager - Technical Manager role overview :
As a Biostatistical Programming Manager - Technical Manager, the successful candidate will oversee the execution and quality of projects managed by FSP and ensure that projects are prioritized according to the product strategy.
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 and deliverable status; 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 programming 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
Thorough understanding of data compliance checks such as Pinnacle 21
Location : Uxbridge or remote based working considered
Remuneration : Competitive salary & comprehensive benefits package including bonus scheme
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.