The Statistical Programmer is responsible for all statistical programming aspects for research, development, and marketed product needs. This position is a key contributor in terms of supporting data analysis, reporting and publication to meet business-critical and regulatory commitments.
The Statistical Programmer is accountable to:
- Lead statistical programming activities at project level.
- Co-ordinate activities of all programmers either internally or externally assigned to the study/studies.
- Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope)
- Review eCRF, discuss data structures and review activities as member of the Data Review Team.
- Comply with company, department and CDISC standards and processes, review and develop programming specifications as part of the analysis plans
- Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications
- Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
- Maintain up-to-date knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and trainings.
- Develop company SAS macros and utilities.
- Knowledge of relevant aspects of therapeutic areas, especially knowledge of oncology and immunology.
- Knowledge of statistical methodology.
- Extensive programming experience in SAS including Data step, Macros, Statistical procedures, and Output delivery system.
- Good knowledge of CDISC standards.
- Bachelor or advanced degree in statistics, computer science, mathematics, life sciences or related fields is required.
- At least 3-5 years in relevant experience in clinical research with emphasis in the development and support of the analysis of clinical data.
- Working experience in oncology projects.
- Experience in performing exploratory analysis to support publication.
- Project management experience.