01Responsibilities
- Write, test and validate software programs in Unix and Databricks to produce analysis datasets and presentation output such as tables and figures, to be included in reports for submission to regulatory agencies, publications and other communications
- 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
- 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, validate and execute department-, product- and protocol-level macros and utilities
- 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
AND
- At least four (4) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
AND
- Experience in SQL, and statistical programming using SAS or R
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
- Robust individual contributor, proficient in developing analysis datasets, identifying data anomalies, and ensuring program accuracy
- Global collaboration on studies to clarify and implement analyses described in Statistical Analysis Plans
- Project fulfillment, statistical programming, issue escalation, results delivery
- Statistical programming: SQL required; SAS or R required; Python preferred
- Motivated to learn how to work 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 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
- OMOP common data model
- Drug development life .
