What are the responsibilities and job description for the Statistical Programmer II position at Katalyst CRO?
Responsibilities
- Develop statistical programs in SAS to generate the clinical datasets, tables, listings and figures.
- Perform validation and QC of the programs, datasets and statistical reports per study requirements.
- Develop and review CDISC SDTM and ADaM mapping specifications.
- Responsible for study closeout and providing submission-ready statistical programming deliverables to the client.
- Ensure compliance of CDISC SDTM and ADaM datasets by running OpenCDISC validator and documenting issues.
- Generate and review submission documents such as define.xml, SDTM annotated CRF, and reviewers guide.
- Ensure review of study documents such as Protocol, CRF, and SAP.
- Communicates effectively within a project team to complete assigned tasks on time and within budget.
- Effectively implement and promote use of established standards, SOP and best practices.
- Provide training and mentoring to junior programmers in the team.
- Master's degree or equivalent and relevant formal academic / vocational qualification.
- 5yrs SAS programming experience.
- 1-2yrs CDISC implementation experience.
- Proficient in SAS and Macros and have developed macros to automate functionality.
- Participated as production or QC programmer at a product and/or study level.
- Experience working in Oncology, CNS or Rare Disease therapeutic areas.
- Good organizational, interpersonal, leadership and communication skills.
- Ability to independently manage multiple tasks and projects.
