Amgen
biotech
BiostatisticalProgrammingSeniorManager
“Biostatistical Programming Senior Manager at Amgen. Skills: Biostatistical Programming, Data & Analytic Center, real-world evidence (RWE) observational studies, programming staff management, technical solutions, process improvement, analysis dataset specifications, software programs, macros and utilities. programming activities supporting the obesity therapeutic area. development and execution of real-world evidence (RWE) observational studies”
What You'll Achieve.
ensures adequate and timely delivery of results; ensure high quality and timely delivery of observational research programming deliverables; produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
Industry & Context.
Provide technical solutions to programming problems within CfOR
Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies
What They're Looking For.
Must Have
Doctorate degree and 2 years of experience OR Master’s degree and 4 years of experience OR Bachelor’s degree and 6 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience, management of a technical team, comprehensive understanding of statistical programming languages and platforms, real world data, claims, EMR databases
Nice to Have
Bachelor’s or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject, ten (10) years clinical research and development programming and managing experience, ten (10) years project management, software application development and managing experience, Drug Development (pre-, early, late and/or observational) in related industries or academic research), Project planning and management, Process improvement leadership, Participation in the development of policies and SOPs, International co-operation, Computer programming, preferably SAS or other procedural languages, Understanding of computer operating systems, UNIX preferred, Biostatistical Programming within Drug Development, Drug Development Process & Operations, Software development & design
What You'll Do.
programming activities supporting the obesity therapeutic area
development and execution of real-world evidence (RWE) observational studies
oversight of the US programming team
and managing resources
develop and implement departmental standards
Write and/or review and approve all programming plans
Write and/or review and approve analysis dataset specifications
Review Requests for Proposals (RFPs) from outsourcing vendors for programming services
Lead and/or participate in the development and review of CfOR Policies
SOPs and other controlled documents
Participate in study and systems audits
Participate in the recruitment of programming staff
How You'll Work.
Team & Collaboration
Represent the programming function and participate in multidisciplinary project team meetings; Provide input to and participate in intra-departmental and CfOR meetings
Communication Scope
Respond to audit questions and findings
Process & Methodology
Project manage all programming activities, according to agreed resource and timeline plans, Project planning and management
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