ExecutivePlacements.com · 1 day ago
Senior Statistical Programmer - Remote
United States
Full-time
Remote
Senior Level, Lead/Staff
8+ years expExecutivePlacements.com is seeking a Senior Statistical Programmer to support programming activities within CNS for clinical trials and regulatory submissions. The role involves transforming raw clinical data into analysis-ready datasets and contributing to the improvement of programming processes.
Human ResourcesOnline PortalsRecruiting
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
Qualification
Required
Bachelor's or Master's degree in biostatistics, computer science, or related fields
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
Strong communication skills and the ability to collaborate within cross-functional teams to manage priorities and meet deadlines are essential
Preferred
8 years in statistical programming within the pharmaceutical, biotechnology, or CRO industry, including regulatory submissions within CNS is preferred
Proficiency in additional programming languages such as R or Python, along with experience using SAS/Graph and statistical packages, is preferred
Company
ExecutivePlacements.com
Online recruitment
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase