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Job Summary:
Everest Clinical Research Services Inc is seeking a highly skilled and experienced Director, Biostatistics to join our team. As a key member of our leadership team, you will be responsible for providing strategic direction and leadership to our biostatistics department.
Key Responsibilities:
- Provide leadership and expertise in resolving complex operational and technical problems in support of division/company objectives and projects.
- Maintain expertise in industry norms, trends across biostatistics, statistical programming, and regulatory requirements.
- Provide supervision to ongoing projects by applying management skills, regulatory standards and requirements, and quality management to ensure quality and timely deliverables.
- Build and maintain relationships with assigned clients to ensure biometrics services are well represented and that communication with the client and the functional teams are clear.
- Represent biostatistics and statistical programming for the company in external business development, regulatory or industry consortiums.
- Represent biostatistics and statistical programming functional service groups in external and internal audits, as well as qualification/maintenance audits for vendors contracted by Everest.
- Monitor and assess the progress status of ongoing projects. Ensure high quality standards, on time delivery within budget for all stages of the clinical trials – from the trial design, protocol development, statistical analysis planning and execution, to the writing of statistical sections of the Clinical Study Reports or the generation of publications of trial results.
- Provide leadership and expertise in day-to-day statistical operations and development of statistical methodologies to solve practical statistical problems.
- Serve as a principal level biostatistician, working effectively with interdisciplinary teams to contribute to drug development at the study and drug compound levels. Provide statistical consultation to trial medical/clinical personnel when required.
- Participate in development of study concepts and study protocols.
- Lead statistical and programming teams on assigned projects. Plan and manage resources, timelines, and quality of statistical and programming deliverables.
- Perform planned, ad hoc, and/or exploratory statistical analyses.
- Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports, publications, abstracts, posters, presentations, etc. Review statistical documents generated by others.
- Perform independent validation of statistical results generated by others and perform third level Quality Control review on statistical and programming deliverables before they are released to the clients.
- Interact with regulatory agencies and support client in New Drug Applications/Biologic License Applications. This includes participating as a statistical liaison to the regulatory agency on behalf of the client and ensuring documentation, statistical results, and study datasets meet the regulatory agency's requirements and expectations (e.g., CDISC).
- Mentor and supervise direct and indirect subordinates. Perform semi-annual and annual performance reviews and prepare developmental plans for direct subordinates and indirect subordinates, where appropriate, through contributing to the performance evaluation process.
- Plan and manage resourcing plans by working with the Project Management group in forecasting resource needs relative to the roles of the personnel. Proactively and continually update the plan with changes to demand, and identify/solution resourcing gaps or overage.
- Participate in recruiting and staffing for responsible functional area, as well as coaching, mentoring, and developing staff members.
- Contribute to the company's management team function and activities.
Qualifications and Experience:
A Ph.D. degree in statistical science, mathematical analysis, or related fields with at least 12 years of relevant experience or a Master's degree in these fields with at least 15 years of relevant experience and a minimum of 4 years managing people, with demonstrated exceptional ability and performance.
Significant contribution, and/or outstanding/sustained performance may be used in lieu of the requirement on the number of years of relevant experience.
