Job Description

• 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:

• 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.

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