Statistical Programmer

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.

Requirements :