about 1 month ago
My client is a well-established biotechnology company with an international presence. Focused in developing cancer treatments, they successfully launched products globally and have an expansive pipeline of candidates in all phases of drug development. Currently seeking an 'Associate Director, Biostatistics' to oversee clinical design, data analysis, and review of scientific and regulatory documents. Offering an exceptional benefits package and the opportunity to work in an entrepreneurial environment.
- Manage statistical projects including clinical trial design randomization, sample size calculation, interim analyses, etc.
- Management and oversight of CROs and external biostatisticians
- Analyze and interpret clinical data
- Work cross-functionally with other departments including clinical and regulatory
- Author and manage statistical sections of regulatory documents, CDISC submission package, IB updates, and PSUR
- MA or PhD in Biostatistics or Statistics
- 6+ years pharmaceutical, biotech, or CRO experience
- Demonstrated ability to apply principals of advanced statistical methodology and interpret technical mathematical instructions with abstract and concrete variables
- Strong SAS programming skills
- Experience with oncology studies preferred
This is a great opportunity to take on greater responsibility and advance your career in an organization that values your opinion.
Please direct all questions to firstname.lastname@example.org or 347.305.7665.