To perform this job successfully an individual must be able to perform each essential function satisfactorily.
- Generate randomization schedules.
- Provide sample size calculations.
- 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 Bio-statisticians.
- Generate/Validate analysis data-sets, tables, figures, and listings to support the analysis of clinical trials data using SAS.
- Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
- Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
- Provide statistical analysis and reports to Data Monitoring Committees (DMCs).
- Review output across programs to ensure consistency.
- Prepare statistical sections of clinical study reports.
- Other duties as assigned.
- Master’s degree in Statistics and a minimum of 5 years of relevant industry experience.
- Knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
- Experience with SAS.
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
- Excellent communication and interpersonal skills to effectively interface with others.
REQUIRED KNOWLEDGE AND ABILITIES:
- Strong verbal and written communication skills are essential.
- Excellent organization and multi-tasking skills.
- Exceptional interpersonal skills and problem solving capabilities.
- Proven meeting planning skills.
- Ability to work effectively across a matrix organization.
- Ability to work independently and prioritize with minimal daily instruction.
- Ability to think strategically in order to improve current processes.