A global pharmaceutical organization is seeking an Associate Director / Director of Biostatistics to provide statistical assistance across Oncology, CNS, and Infectious Disease projects. You will be playing a major role in to build and lead the group of Biostatistics and Data function, beginning with study design through to final data set deliveries and submissions.
- Oversee all the biostats activities and act as a point of contact for all Sample design and statistics inquiries from internal and external stakeholders.
- Collaborates effectively with internal/external functional teams to ensure high quality deliverables and maintains efficient communication with all parties within the global team
- Interact and manage CROs and represent the company in external scientific meetings including interaction with KOLs and communication with worldwide regulatory agencies.
- Participating in the organization's future programs and oversee the growth of the biometrics division.
- Ph.D. in Statistics/ Biostatistics with 5+ years of experience in pharmaceutical industry.
- Experience in designing Phase I/II/III clinical trials, oncology/CNS trial design experience a plus.
- Experience in designing and implementing several dynamic randomization plans.
- Experience in CRO management a plus.
- Experience in interaction with regulatory authorities.
- Experience with application of a variety of statistical methods and ability to work on complex statistical problems.
- Solid knowledge of SAS and familiarity with other statistical software packages.
- Have thorough understanding of regulatory guidance and statistical methodology as applied to pharmaceutical development.