STRATEGIC CONSULTING STATISTICIAN
Department: Strategic Scientific Consulting
Supervisor: Chief Scientific Officer & Sr. Vice President Strategic Scientific Consulting
Job Summary:
SDC is seeking a committed, energetic, and detail-oriented Statistician to join our growing team. The Strategic Consulting Statistician will support the Chief Scientific Officer and Senior Vice President of Strategic Scientific Consulting. He/She will provide statistical science consultation, project management, and statistical analysis for clinical trials. As well as maintaining the statistical integrity of the clinical trials developed by SDC. He/She will lead the development and maintenance of strategic standard libraries towards ensuring the consistency of design and statistical analyses approaches across studies. Also, he/she will research and implement new statistical techniques.
Primary Responsibilities:
- Develops Clinical Study Protocol designs and statistical analysis strategies under the guidance of management, including endpoint determination, sample size calculation, analysis population definitions, and primary analysis strategies (primary model and missing data imputations strategies as well as sensitivity analyses).
- Manages communications with clients including determining available meeting times, maintaining brief action items, and ensuring timely follow-up
- Creates and maintains a library of:
- Standard protocol section text for frequently captured and summarized measures (i.e. Demographics, Disposition, and Safety Measures) under the guidance of management.
- Standard protocol section text for Multiplicity Considerations, Missing Data, and Estimands under the guidance of management
- Acceptable endpoints and time points by therapeutic area and indication
- Standard FDA feedback and responses thereto
- Consults internally and externally on complex statistical strategies, including researching and developing new models or techniques and presenting to the Biostatistics department.
- Completes one-off analyses for clients.
Required Skills:
- Strong statistical background in theory and application
- Fluent in English with the ability to communicate effectively in writing and verbally at all levels of clients, suppliers, and employees
- Ability to develop and deliver presentations
- Ability to think critically and consider multiple alternatives around an obstacle, anticipating advantages and drawbacks of each
- Good organizational and time management skills, with the ability to multi-task
- Ability to identify operational inefficiencies and present and implement solutions
- Some knowledge and familiarity with clinical trial design and analysis activities and regulatory guidelines (FDA/CFR, ICH/GCP) and requirements, especially as pertains to statistical and study design and analysis is an advantage
Education:
- A PhD in Biostatistics or other related mathematics field