The Director/Sr. Director will provide statistical leadership and expertise in support of the clinical development and postโmarketing activities for multiple therapeutic areas.
Duties and Responsibilities
The duties and responsibilities include but are not limited to the following:
- Responsible for leading the Biostatistics platform for assigned projects in ensuring effective, timely, high quality and compliant management and delivery of project goals and Provide expert statistical input and consultancy to Phase I - IV global clinical trials, lifecycle management activities as well as Translational Medicine research efforts
- Actively participate in project teams as the Biometrics Interacts strategically with crossโ functional teams and other functional areas to ensure timely project deliverables; maintains consistently high performance standards and quality of work and ensure all clinical development programs meet scientific, regulatory, quality and commercialization requirements
- Provides strategic thinking and statistical expertise to define the right questions to be answered in the design of clinical trials; specifically contributes from a statistical perspective to the creation of the Clinical Development Plans
Qualifications
- A PhD in statistics or biostatistics with minimum 12 years of clinical development experience in the pharmaceutical/biotech industry
- Proficiency with statistical analysis software such as SAS or R
- Solid understanding of clinical trial principles and regulatory requirements
- Knowledge of industry data standards
- Effective verbal and written communication and strong interpersonal skills
- Demonstrated ability to work in a team environment
