Due to recent growth among a project, a leader in the Biotech industry is looking to grow their Biometrics team. A Mid-Sized Biotech company is looking for a Associate Director of Biostatistics to add to their team. Here, you will be responsible for leading statistical activities for clinical development programs and also assigned projects. Supporting complex studies, monitoring, working on analysis and development of SAP's and drug development plans of clinical trials for assisting a submission to the NDA/FDA.
The AD of Statistics will be responsible for:
- Provide leadership and guiding biostatisticians and programmers with developing SAP's. Act as the main Statistical point of contact for assigned projects and assignments. Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.
The AD of Statistics should have the following qualifications:
- BA,B.S, or Masters minimum in Statistics, Computer Science, Mathematics, or related field.
- 8-10+ years of pharmaceutical/biotech industry experience
- Experience creating SAP's and CDPP's
- Prior CRO/Vendor Management Experience is preferred
- Background and understanding of PLA/NDA submissions
- Experience with Bayesian Statistics, adaptive design, and comparison procedures
- Strong Oral and Written communication skills
- Significant knowledge of pharmacology, clinical research, and medical terminology and use it for study design and results interpretation.
- Remote Opportunity
- Health Benefits (Dental, Vision, Medical)
- Competitive Pay