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Director of Biostatistics and Operations
2 months ago
**About the Role**
We are seeking a highly skilled and experienced Director of Biostatistics and Operations to join our team at Warman O'Brien. As a key member of our leadership team, you will be responsible for managing clinical trial programs and projects from one or multiple clients.
Key Responsibilities:
- Provide day-to-day technical and operational leadership to project teams supporting clinical trial programs and projects.
- Perform semi-annual and annual performance reviews and develop developmental plans contributing to the performance evaluation process.
- Lead statistical and programming teams, interact with clients and/or internal project leaders to plan and implement statistical and programming project plans, and deliver quality deliverables.
- Ensure sound statistical methodologies in study design, sample size estimation, statistical analysis planning, data handling, statistical modeling, testing, analysis, and reporting.
- Participate in the writing of trial protocols and research proposals.
- Review and provide input to clinical data management deliverables.
- Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports (CSRs).
- Perform hands-on statistical analysis and modeling; maintain expertise in state-of-the-art statistical methodology and regulatory requirements.
- Perform overall quality control (QC) review on statistical deliverables before they are released to clients.
- Perform QC activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians.
- Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.
- Interact with regulatory agencies and support Sponsor in new drug application.
- Perform statistical and programming resource management, capacity analysis, benchmarking, and generation of performance metrics.
- Assist in business development activities, including but not limited to the following: provide cost estimates of statistical and programming services; participate in generation of project proposals and bid defense meetings; Perform tracking of out-of-scope services on assigned projects, provide cost estimates, and draft change orders to existing services work orders.
Requirements:
- Degree in statistical science, mathematical analysis or related fields or a Master's degree in these fields.
- Demonstrated exceptional ability and performance.
