Manager - 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 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. The ideal candidate should possess a bachelor’s 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.

Responsibilities

• Lead a statistical programming team conducting analyses supporting Amgen's Regulatory submission studies and Projects

• Coordinate with functional leads to prioritize and manage 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

• Project manage programming activities, according to agreed resource and timeline plans

• Review and approve key study-related documents produced by other functions, e.g. SAPs, Data Management Plans, etc.

• Write and/or review and approve 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

• Oversee the work of outsourced resources assigned to projects

• 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

• Manage staff performance and oversee staff assignments and utilization

Basic Qualifications

• 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

AND

• Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in statistical programming projects

Preferred Qualifications

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

Experience:

• Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials

• Team management

• Global collaboration

• Request fulfillment oversight, clarifying requirements, project tracking, project fulfillment, statistical programming, issue resolution, expert resource, results delivery

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

• Working with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV)

Key Competencies

• CDISC (SDTM, ADaM)

• Hands-on programming and lead role

• 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

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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.