- Lead and develop technical programming and process improvement initiatives within CfOR
- Design data quality enhancements
- Represent the programming function and participate in multidisciplinary project team meetings
- Project manage all programming activities, according to agreed resource and timeline plans
- Ensure all programming activities on the project adhere to departmental standards
- Write and/or review and approve all 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 complete department-, product- and protocol-level macros and utilities
- Be responsible for the work of outsourced resources assigned to project
- 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:
- Bachelors degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject.
- At least 6-8 years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
Preferred Qualifications:
- Masters 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: 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
- Required: Experience with data quality or data quality platforms (for example: Informatica, Ataccama)
- Preferred: Python
- Preferred: R
- 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
- Scientific / technical excellence
- Oral and written communication, documentation skills
- Leadership
- Innovation
- Teamwork
- Problem solving
- Attention to detail
