Associate - RWE Regulatory Statistical Programming

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 (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
• Global collaboration
• Statistical programming: SQL required; SAS or R required; Python preferred

Key Competencies

• 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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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.