Associate - RWE Obesity Statistical Programming

Location: Prakāshamnagar

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Observational research (OR) is an increasingly important component in drug development and commercialization, because in the current environment, there is increased demand for information from OR studies for regulatory and reimbursement authorities. The Center for Observational Research (CfOR) at Amgen partners with teams to generate real world evidence for multiple stakeholders across the product lifecycle. CfOR contributes evidence regarding the frequency and distribution of disease or the clinical burden of disease, the natural history or clinical course of disease, the design of clinical trials, cost and utilization patterns, and the safety and effectiveness of interventions.

Amgen is seeking a dedicated Associate Biostatistical Programmer to join our Center for Observational Research (CfOR) organization, based in Hyderabad, India. This crucial role involves generating Real-World Evidence (RWE) to support Amgen products throughout the drug development lifecycle. The successful applicant will collaborate with teams across multiple time zones to fulfill requests, clarify requirements, escalate issues, and deliver high-quality results. The Associate Biostatistical Programmer will report to a locally based Biostatistical Programming Manager.

The Associate Biostatistical Programmer will be responsible for hands-on programming and results delivery. Additionally, they will be responsible for manipulating large databases and generating reports to enable epidemiologists to explore and generate RWE from real-world healthcare data assets. The ideal candidate should possess a bachelor's degree and have at least two years of relevant career experience in statistical programming. Proficiency in SAS and SQL programming is required, while experience with R and Python is preferred.

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.

Responsibilities:

Write, test and validate software programs in Unix and Databricks to produce analysis datasets and presentation output such as tables and figures, to be included in reports for submission to regulatory agencies, publications and other communications
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
Manage all programming activities, according to agreed resource and timeline plans
Ensure all programming activities on the project adhere to departmental standards
Write and/or review and approve all programming plans
Write and/or review and approve analysis dataset specifications
Write, test, validate and execute department-, product- and protocol-level macros and utilities
Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
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)

Basic Qualifications:

Bachelor's degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject

AND

At least two (2) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting

AND

Experience in statistical programming using SAS and SQL

Preferred Qualifications:

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:

Strong individual contributor, proficient in developing analysis datasets, identifying data anomalies, and ensuring program accuracy
Global collaboration on studies to clarify and implement analyses described in Statistical Analysis Plans
Project fulfillment, statistical programming, issue escalation, results delivery
Statistical programming: SAS and SQL required; R and Python preferred
Motivated to learn how to work with real-world healthcare data (RWD) such as healthcare claims (Market Scan, Optum Cl informatics, Medicare) and EHR databases (Optum EHR Pan Ther, Flatiron, CPRD, MDV)

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