Associate Director, Biostatistics
Proclinical is currently recruiting for an Associate Director of Biostatistics with a leading biotechnology company located in Boston, MA. Successful candidate will participate in meetings and teleconferences with regulatory agencies and prepare written responses to agency questions.
- Apply complex and innovative statistical approaches to your work (e.g. modeling and simulation, adaptive design/Bayesian statistics).
- Provide interpretive and analytical publication support, safety surveillance, pharmaco-economic initiatives and statistical consulting advice to other functions as needed.
- Participate in meetings and teleconferences with regulatory agencies and prepare written responses to agency questions.
Skills and Requirements:
- PHD in Biostatistics or Statistics with 6+ years of pharmaceutical, biotechnology or equivalent experience, or Masters in Biostatistics or Statistics with 10+ years of pharmaceutical, biotechnology or equivalent experience.
- Comprehensive knowledge of statistical theory and methods and demonstrated ability to apply it in designing data acquisition trials, assessing results, analyzing trend.
- Expertise in SAS programming including statistical analysis, data manipulation and scientific graphing.
- Prior experience communicating with and presenting to the US FDA and European Regulatory Authorities.
- Prior experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submission.
- Demonstrated knowledge of all relevant statistical regulatory guidance and standards (e.g. FDA, ICH and EMEA).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Miles Tobin at (+1) 617-545-5922 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.