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 Bachelor's or Master's degree in biostatistics, computer science, or related fields 8 years in statistical programming within the pharmaceutical, biotechnology, or CRO industry, including regulatory submissions within CNS is preferred. Advanced SAS programming; CDISC standards expertise; knowledge of additional programming languages (R, Python) is a plus. Strong Macro and tool development and validation Experience in BLA, NDA/sNDA submissions. Proficiency in additional programming languages such as R or Python, along with experience using SAS/Graph and statistical packages, is preferred. Strong communication skills and the ability to collaborate within cross-functional teams to manage priorities and meet deadlines are essential.