Senior Associate - RWE Regulatory Statistical Programming

Amgen is seeking a dedicated Biostatistical Senior Programmer 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 Senior Biostatistical Programmer 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 withepidemiologists to explore and generate RWE from real-world healthcare data assets. The ideal candidate should possess a bachelors degree and have at least six years of relevant career experience in statistical programming. Proficiency in SQL programming and SAS or R programming is required. The successful candidate will demonstrate scientific and technical excellence, exceptional oral and written communication skills, problem-solving abilities, and meticulous attention to detail. The ability to work effectively within a large, globally distributed team is essential.

• Support a statistical programming team conducting analyses supporting Amgen''s Regulatory submission studies and projects
• Coordinate with functional leads to prioritize workflow
• Provide technical solutions to programming problems within CfOR
• Ensure the analysis and presentation of biomedical data is accurate and complete
• Adhere to Amgen policies, SOPs and other controlled documents
• Write, test, and validate programs in SAS, Databricks, or R to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications, and other internal and external communications
• Complete programming activities, according to agreed resource and timeline plans
• Review key study-related documents produced by other functions, e.g. SAPs, Data Management Plans, etc.
• Write and/or review programming plans and analysis dataset specifications
• Represent the programming function and participate in multidisciplinary project team meetings
• Lead and develop technical programming and process improvement initiatives within CfOR
• Write, test and validate department-, product- and protocol-level macros and utilities
• Provide input to and participate in intra-departmental and CfOR meetings
• Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings

Basic Qualifications

• Bachelors degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
• At least four (4) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting

• Masters degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject

• Working with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV)
• Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
• Team management
• Global collaboration
• Statistical programming: SQL required; SAS or R required; Python preferred

• CDISC (SDTM, ADaM)
• Hands-on programming
• Expert statistical programming knowledge using SAS or R
• Required: SAS or R
• Required: SQL
• Preferred: Python
• Excellent verbal and written communication skills in English
• Ability to have efficient exchanges with colleagues across geographical locations
• Agile project management
• Real-world data (RWD) including insurance claims databases, electronic medical records and patient registries; for example, MarketScan, Optum, PharMetrics, Flatiron, Medicare
• Drug development life cycle
• Statistics and basic epidemiology: Incidence and prevalence
• Scientific / technical excellence
• Oral and written communication, documentation skills
• Leadership
• Innovation
• Teamwork
• Problem solving
• Attention to detail