Senior Statistical Programmer - Remote

Contact : Neisha Camacho / Terra Parsons - teamnt@penfieldsearch.com

No 3rd party candidates

Senior Statistical Programmer to support programming activities within CNS in support of clinical trials and regulatory submissions. In this role, you will transform raw clinical data into analysis ready datasets, generate high-quality TLFs, and contribute to the continuous improvement of analysis workflows and programming processes.

Key Responsibilities :

• Provide statistical programming support to generate SDTM and ADaM data sets, tables, listings, and figures for individual studies as well as ISS / ISE analyses.
• Provide programming support to internal teams including identifying, reporting, and resolving raw data issues
• Participate in the review of statistical analysis plans, table specification, develop specification for SDTM and ADaM data sets.
• Participate in study team meetings and address issues that may affect statistical programming.
• Support and participate in the preparation of clinical study reports, regulatory submissions, and annual DSUR and safety reports.
• Perform ad hoc analyses and data validation.
• Develop and maintain necessary programming macros or tools to effectively support all programming needs
• Develop and contribute to internal teams SOPs and working documents related to EDC studies, FDA requests, independent validation, and general statistical programming processes.

Qualifications