Associate - RWE Regulatory 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.

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.

Responsibilities

Support a statistical programming team conducting analyses supporting Amgen's Regulatory submission studies and projects
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
Create key study-related documents produced by other functions, e.g. SAPs, Data Management Plans, etc.
Write programming plans and analysis dataset specifications
Develop technical programming and process improvement initiatives within CfOR
Write, test and validate department-, product- and protocol-level macros and utilities
Provide input for 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

Bachelor's degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
At least two (2) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting

Preferred Qualifications

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

Experience:

Working 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)
Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
Global collaboration
Statistical programming: SQL required; SAS or R required;
Python preferred

Key Competencies

CDISC (SDTM, ADaM)
Hands-on…