What are the responsibilities and job description for the Statistical Programmer position at Katalyst CRO?
Responsibilities
- Provide statistical programming support to generate SDTM and ADaM datasets, tables, listings, and figures for individual studies and ISS/Client to FDA, EMA, and other worldwide regulatory agencies.
- Participate in the review of statistical analysis plans and TLF specifications.
- Review or annotate CRFs for SDTM mapping, review/author SDTM/ADaM dataset specifications.
- Review, and comment on CRFs, vendor data transfer specifications (DTS), edit checks and other study data related documents.
- Support in the preparation of study reports, regulatory submissions, and annual safety update reports.
- Perform additional analysis and validation for data checking, publication, presentation, poster, and ad hoc analysis.
- Work with CRO statistical programmers and perform statistical programming vendor oversight.
- Contribute to Biometrics SOPs and work instructions related to EDC studies, FDA requests, and statistical programming processes.
- Contribute to department process improvement initiatives.
- Support department infrastructure builds up by developing, validating, and testing the macros, utilities, and tools.
- Keep abreast of literature and advancements in SAS.
- Bachelor's or master's degree in biostatistics, computer science, or related fields, master's degree preferred.
- At least 8 years of relevant experience, including as a Lead Statistical Programmer, in the biotech or pharmaceutical industry.
- The ideal candidate must be able to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
- Proficient of SAS programming in a regulated clinical research environment.
- Experience of programming and validation of SDTM and ADaM data sets, tables, figures, and listings.