Career Category
Clinical
Job Description
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peopleās lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worldās 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.ā 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 withĀ epidemiologists to explore and generate RWE from real-world healthcare data assets. The ideal candidate should possess a bachelorās 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:
- 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
- Project manage programming activities, according to agreed resource and timeline plans
- Ensure programming activities adhere to departmental standards and SOPs
- Write and/or review and approve programming plans
- Write and/or review and approve analysis dataset specifications
- Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
- Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
- Write, test, validate and execute department-, product- and protocol-level macros and utilities
- Oversee the work of outsourced resources assigned to projects
- Lead and/or participate in the development and review of CfOR policies, SOPs and other controlled documents
- 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
- 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)
- Manage staff performance and oversee staff assignments and utilization
Basic Qualifications:
- Bachelorās 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:
- Masterās 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:
- 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
- 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)
Key Competencies
- 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)ā including insurance claims databases, electronic medical records and patient registries; for example, MarketScan, Optum, PharMetrics, Flatiron, Medicare
- OMOP common data model
- Drug development life cycle
- Statistics and basic epidemiology: Incidence and prevalence
- [Required for Regulatory RWE role]: CDISC (SDTM, ADaM)
- 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 peopleās lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worldās leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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