Lead and develop technical programming and process improvement initiatives within CfORDesign data quality enhancementsRepresent the programming function and participate in multidisciplinary project team meetingsProject manage all programming activities, according to agreed resource and timeline plansEnsure all programming activities on the project adhere to departmental standardsWrite and / or review and approve all programming plansWrite and / or review and approve analysis dataset specificationsReview 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 communicationsWrite, test, validate and complete department-, product- and protocol-level macros and utilitiesBe responsible for the work of outsourced resources assigned to projectLead and / or participate in the development and review of CfOR Policies, SOPs and other controlled documentsParticipate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findingsParticipate in the recruitment of programming staffActively participate in external professional organizations, conferences and / or meetingsProvide input to and participate in intra-departmental and CfOR meetingsContribute to the continuous improvement of programming, CfOR, and Research and Development (R&D)Manage staff performance and oversee staff assignments and utilizationBasic 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
Skills Required
Data Quality, Sas, Programming, Sql