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Location: Maryland suburb
Up to $120k with bonus.
Associate Director of Biostatistics- (open to a Sr./Lead or Manager. This is for a pharmaceutical related company working with clinical biostatistics)
This position oversees all or part of the Department of Biostatistics and functions as a Senior Biostatistician, Project Director on projects as needed. The Biostatistics Department is responsible for the statistical aspects of clinical trials, including experimental design, statistical analysis, and reporting.
1. Oversees statistical input to study design, analysis, and reporting. Directs collaboration with medical scientists in the design of clinical studies and the development of study protocols. Ensures that appropriate analysis procedures are used and that study reports accurately describe statistical methods and results of analyses.
2. Oversees statistical activities that support Company's interactions with clients and regulatory agencies.
3. Provides input to client clinical and regulatory departments on statistical issues relating to client regulatory submissions.
4. Reviews and approves statistical methods sections of study protocols, statistical analysis plans, statistical analyses, and statistical input to reports.
5. Ensures that Biostatistics Department projects within the local office are conducted within budget and in a timely and quality manner.
6. Reviews and approves timesheets for direct reports. Reviews and approves project time reports for biostatistics projects conducted in the local office.
7. Conducts regular departmental meetings.
8. Organizes and conducts interdepartmental project review meetings designed to coordinate data management, biostatistics, statistical programming, quality assurance, medical writing, and business development resource allocation and timelines.
9. Assigns projects to biostatisticians within the local office and monitors staff utilization. Adjusts workloads when needed.
10. Monitors progress on biostatistics projects within the local office. Assists staff members with the identification of out-of-scope work and, when necessary, works with Business Development Associates to secure additional project funding.
11. Recruits, hires and trains new biostatisticians for the local office.
12. Conducts performance reviews.
13. Collaborates with Biostatistics Departments in other locations within Company to develop and maintain standard operating procedures (SOPs) and study specific procedures (SSPs). Ensures that biostatisticians within the local office operate according the SOPs and SSPs.
14. Prepares and approves research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients in the pharmaceutical, biotechnology, computer, and manufacturing industries. As needed, participates in proposal defense meetings and makes presentations at marketing meetings with prospective clients.
15. Documents all work to ensure an adequate audit trail and reproducibility. Participates in the setting of document standards.
16. Functions as a Senior Biostatistician, Project Director on projects as needed.
17. Performs additional duties as assigned.
Ph.D. or M.S. in statistics, biostatistics, or related field in statistical applications in the pharmaceutical industry. History of management responsibility, including at least 1 year experience in a leadership role. Knowledge of a wide variety of principles, theories, and concepts in statistics and experimental design; must be able to apply them to the development and analysis of clinical trials. Comprehensive knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS, are a must. Good interpersonal skills to motivate and direct activities of staff and interdisciplinary teams are essential.
Please contact: Craig at email@example.com, or call 952 473-2821