Biostatistical Programming Mgr
US - California - Thousand Oaks - Field/Remote
Career Category
ClinicalJob Description
HOW MIGHT YOU DEFY IMAGINATION?
Youâve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youâve worked hard to acquire and the passion you already have. At Amgen, our shared missionâto serve patientsâdrives all that we do. It is key to our becoming one of the worldâs leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Biostatistical Programming ManagerLive
What you will do
Letâs do this. Letâs change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate.
The Technical Manager 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. The Technical Manager will also provide technical consultancy to our FSPs on Amgen processes, tools and utilities.
Responsibilities:
Oversee the execution and quality of projects managed by our FSPs per Amgen Global Statistical Programming (GSP) Quality Oversight Plan (QOP)
Align FSP assignments with Amgen Development priorities
Ensure that FSP programming meets quality, compliance, timeline, and productivity expectations
Contribute to FSP training material development and revisions, and conducting the initial training to FSP staff
Provide guidance and technical consultancy to FSP Study Lead Programmers (SLP) on Amgen processes, tools, and utilities
Contribute to FSP performance metrics development, data collection, and reporting
Review project documentations such as specifications, issue logs, deliverable status for accuracy and completeness
Advise FSP SLP on study-specific questions for specifications, documentation, and coding
Lead/contribute to GSP continuous improvement initiatives
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is proficient with these qualifications.
Basic Qualifications:Doctorate degree OR
Masterâs degree and 2 years of statistical programming experience OR
Bachelorâs degree and 4 years of statistical programming experience OR
Associateâs degree and 8 years of statistical programming experience OR
High school diploma / GED and 10 years of statistical programming experience
Preferred Qualifications:
MSc in Computer Science, Statistics, Mathematics, Life Sciences or another relevant scientific subject
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 âŚ
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Tasks- Training
Biotechnology Clinical trials Collaboration Communication Compliance Computer Science Execution Python R SAS SAS/GRAPH SAS/MACRO SQL Statistics
Experience6 years
EducationAssociate Associates Bachelor's DO Doctorate Doctorate degree GED High school diploma Life Sciences Master's Mathematics Statistics
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9