About The Position
ClinChoice is searching for an Associate Director Biostatistician Consultant to join one of our clients. This is a client-facing role where candidates are expected to work independently while establishing a high-trust environment with the client’s counterparts. The position will require minimal supervision from senior department staff and will represent the Biostatistics function for complex studies or at a project level. The role involves contributing to the design of early/late-stage protocols across multiple therapeutic areas, drafting protocols or amendments, developing and writing statistical analysis plans, and performing statistical analyses for interim and final reports for regulatory submissions. Additionally, the position will support submission activities, including the design, analysis, and reporting of integrated summaries for safety and efficacy. Attendance and statistical contributions at study team meetings or project level meetings are expected. Leadership skills are needed to contribute to the organization and scheduling of study deliverables in collaboration with Statistical Programmers and Data Managers.
Requirements
- MS or PhD in Statistics or Biostatistics
- PhD + 6 years (or MS + 11 years) clinical trial experience in either a biotechnology or pharmaceutical company
- Hands-on Phase I/II/III clinical trial experience
- Proficient in SAS programming
- Excellent oral and written communication skills
Nice To Haves
- Excellence in R programming desirable
- Previous experience with regulatory submissions in the US, Europe, Japan, and Rest of the World, is desirable
Responsibilities
- Contribute to the design of early/late-stage protocols across multiple therapeutic areas.
- Draft protocols or amendments.
- Develop and write statistical analysis plans.
- Perform statistical analyses for interim and final reports for regulatory submissions.
- Support submission activities, including design, analysis, and reporting of integrated summaries for safety and efficacy.
- Attend and provide statistical contributions at study team meetings or project level meetings.
- Contribute to the organization and scheduling of study deliverables in collaboration with Statistical Programmers and Data Managers.
Benefits
- Professional development
- Supportive culture
- Additional career opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Senior
