FierceBiotech and FiercePharma Jobs
Manager, Biostatistics - verna scientific
Dec 20
Location: Raleigh, NCCategories: Pharmaceutical
Website: http://www.vernascientific.com
Position Description
Urgent requirement for one of our top clients located in “Raleigh, NC”.
Please contact me at your earliest convenience, along with job No. MB_122008 to glenn.davis@vernascientific.com
Description:
This position also supervises Biostatistics staff, and assists in the development and refinement of existing departmental processes. This role may also involve collaborating in protocol development as required (completing statistical section of protocols), writing and reviewing protocol analysis plans and mocks table shells, and preparing and submitting ICH and regulatory dossiers.
Requirements:
Ph.D. degree in Biostatistics plus 5 years experience with a minimum of 3 years design and analysis of clinical trials experience in a Contract Research Organization (CRO) or Pharmaceutical/Biotechnology company, or a Masters degree in Biostatistics/Statistics with 6 years experience. Experience with preparation and submission of ICH and regulatory dossiers required. Requires in-depth knowledge and application of FDA regulations. Working knowledge of a major statistical software program, e.g., SAS is necessary. Experience with other statistical software such as, StatXact, Nonlin and EaSt is preferred.
