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Amgen is seeking a dedicated Biostatistical Programming Manager to join our Center for Observational Research (CfOR) organization, based in Hyderabad, India. This crucial role involves leading a team of senior statistical programmers who will generate Real-World Evidence (RWE) to support Amgen products throughout the drug development lifecycle. This lead programming role will collaborate with teams across multiple time zones to oversee request fulfillment, clarify requirements, track projects, resolve issues, and deliver high-quality results. The Biostatistical Programming Manager will report to a locally based Director of Biostatistical Programming. The Biostatistical Programming Manager will be responsible for both hands-on programming as well as guiding junior programmers. Additionally, they will be responsible for manipulating large databases and generating reports to partner with epidemiologists to explore and generate RWE from real-world healthcare data assets.
Job Responsibility:
Provide technical solutions to programming problems within CfOR
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming function and participate in multidisciplinary project team meetings
Project manage programming activities, according to agreed resource and timeline plans
Ensure programming activities adhere to departmental standards and SOPs
Write and/or review and approve programming plans
Write and/or review and approve analysis dataset specifications
Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
Write, test, validate and execute department-, product- and protocol-level macros and utilities
Oversee the work of outsourced resources assigned to projects
Lead and/or participate in the development and review of CfOR policies, SOPs and other controlled documents
Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
Participate in the recruitment of programming staff
Actively participate in external professional organizations, conferences and/or meetings
Provide input to and participate in intra-departmental and CfOR meetings
Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D)
Manage staff performance and oversee staff assignments and utilization
Requirements:
Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
At least six (6) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in statistical programming projects
Proficiency in SQL programming and SAS or R programming is required
Scientific and technical excellence
Exceptional oral and written communication skills
Problem-solving abilities
Meticulous attention to detail
Ability to work effectively within a large, globally distributed team
Nice to have:
Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model
Experience with Python programming
Experience with real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
Experience working with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV)