Description
* Provide statistical analysis and reports to Data Monitoring Committees.* Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
* Prepare statistical sections of clinical study reports.
* Generate randomization schedules.
* Provide sample size calculations.
* Generate/Validate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS.
* Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
* Review output across programs to ensure consistency.
* Provide input into development of case report forms (CRFs).
* Author statistical analysis plans, including development of table and listing shells.
* Review statistical analysis plans written by CRO Biostatisticians.
* Knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
* Experience with SAS.
Education & Experience Required: Master's Degree with a minimum of 5+ years of Pharmaceutical or CRO experience, PhD preferred.