The Statistical programmer/Senior Statistical Programmer is responsible for all statistical programming aspects at project level. The position is a key contributor with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high quality deliverable.
- Lead statistical programming activities at project level.
- Co-ordinate activities of all programmers either internally or externally assigned to the study/studies. Make statistical programming recommendations at study level.
- Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope), e.g. as member of the Clinical Trial Team.
- 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.
- Provide input into statistical programming solutions and/or ensure their efficient implementation.
- 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 deliverable 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 training.
- 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 including:
- Study Data Tabulation Model (SDTM)
- Analysis Data Model (ADaM)
- Clinical Data Acquisition Standards Harmonization (CDASH)
- BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related fields is required
- At least 2-3 years’ experience in pharmaceutical company or Clinical Research Organization (CRO) as statistical programmer
- Positive working attitude
- Working experience in oncology projects
- Self-management skills with a focus on deliverables
- Project management experience