- 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
- At least eight (8) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting.
- Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in a statistical programming team working with real-world healthcare data (RWD)
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
- Doctorate degree and 2 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject OR
- Master s degree and 8 to 10 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject OR
- Bachelor s degree and 10 to 14 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject OR
- Diploma and 14 to 18 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
Preferred Qualifications:
Experience:
- Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model.
- Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
- Department or multi-team management
- Global collaboration
- Request fulfillment oversight, clarifying requirements, project tracking, issue resolution, expert resource
- Statistical programming: SAS and SQL required; R and 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
- Required: SQL
- Preferred: R
- 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
- OMOP common data model
- Drug development life cycle
- Statistics and basic epidemiology: Incidence and prevalence
- [Required for International DAC role]: R or SAS
- [Required for Regulatory RWE role]: CDISC (SDTM, ADaM)
- [Required for RWD Engineering role]: Data quality platforms (for example: Informatica, Ataccama)
- Scientific / technical excellence
- Oral and written communication, documentation skills
- Leadership
- Innovation
- Teamwork
- Problem solving
- Attention to detail
