GENERAL SUMMARY/ OVERVIEW STATEMENT:
Leading the Biostatistics department, this position is responsible for oversight of all statistical analyses from assigned TIMI trials. The TIMI Study Group is an academic research organization that has led multiple large-scale, international randomized controlled clinical trials in cardiovascular medicine for over 20 years. The Director of Statistics, using a comprehensive understanding of biostatics with particular expertise in design and analysis of clinical trial data, will collaborate closely with Physician Investigators to determine the proper statistical plan and analyses and plan the statistical work flow of each trial. Additionally, the position is responsible for staff resourcing, achieving departmental objectives, and implementing plans for further improvement of departmental operational processes.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1. Possess a solid understanding of the purpose, objectives and goals of each trial.
2. Collaborates with Physician Investigators to develop statistical plans for investigational protocols and in the preparation of manuscripts, abstracts, and presentations at scientific meetings.
3. Directs and ensures the accuracy and timeliness of each analysis request. Anticipate and communicate quality issues that may impact deliverables or timelines and propose and implement solutions.
4. Ensures adequate staffing resources to meet departmental objectives, through recruiting, selecting, orientating, training, assigning, scheduling, coaching, counseling and disciplining employees; communicates job expectations, planning, monitoring, appraising, and reviewing job contributions, planning and enforcing policies and procedures of Biostatisticians.
5. Assures the maintenance of an up to date binder for all trials recording all data requests and data transmissions performed.
6. Manipulates or oversees the manipulation of datasets across a variety of statistical software formats to allow for integration and pooling across trials.
7. Oversees the compilation and organization of data for transmission to Investigators, Sponsors, and Director of Operations.
8. Develops novel ways to coordinate, manage and report data for new trials.
9. Represents Biostatistics in meetings with cross functional project teams (internally) and regulatory agencies (externally).
10. Ensures adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements by contributing to SOP development and training.
11. Performs other duties as required and as appropriate.