Manager of Biostatistics - Pharmaceutical Client in Bridgewater, NJ area

Manager of Biostatistics - Pharmaceutical Client in Bridgewater, NJ area

send resumes to sruesch@csg-inc.com

Midsized pharmaceutical company in Bridgewater area has an immediate need for a Senior Manager/Manager of Biostatistics. No direct reports. Details are as follows:

Manage and lead biostatistical activities related to drug product development for assigned compounds, indications or studies. Mentor statistical and programming professionals in biostatistics. Collaborate with internal Data Management professionals and manage Data Management and Biostatistical personnel at CROs.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Collaborate with Biostatistics, Clinical and Medical Writing on clinical trial protocols, case report forms, statistical analysis plans, and other study related activities.
2. Assume responsibility to provide statistical services in drug development
3. Provide statistical support for submission of marketing applications (e.g., NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies
4. Collaborate with internal Data Management professionals and manage Data Management and Biostatistical personnel at CROs
5. Collaborate with development partners
6. Mentor statisticians/programmers/consultants
7. Lead statistical activities for assigned clinical trials

ESSENTIAL, KNOWLEDGE, SKILLS, EXPERIENCE:
1. M.S. required in Statistics, Biostatistics, Public Health or related field; PhD recommended
2. Five years experience in clinical trials including marketing applications (NDA/BLA) submissions, including FDA and EMEA experience
3. Excellent communication and writing skills
4. Experience with cancer clinical trials and/or time-to-event data is preferred
5. Excellent programming skills, especially in SAS. S-Plus is a plus
6. Knowledge of FDA, EMEA and ICH guidelines and regulations covering clinical trials, statistics, and data management
7. Knowledge of EDC and CDISC preferred