Watertown Categories:
Biostatistician EnVivo Pharmaceuticals
The Biostatistician is responsible for statistical activities in support of clinical trials, including: contributing to the statistical sections of protocols, preparing statistical analysis plans, reviewing and interpreting the analysis of clinical trial data, and proving guidance to statistical programming and data management functions. Job Objectives and Tasks:
? Works with the Clinical Development group to provide input to study design and the statistical section of clinical trial protocols
? Contributes to or prepares statistical analysis plans
? Generates and/or verifies sample size calculations and randomization schemes
? Performs quality control checks of SAS programs
? Provides guidance to Statistical Programmer for TFL specifications and statistical methodology required
? Provides input to database requirements and works closely with Clinical Data Manager to insure data quality standards are met
? Prepares summaries and graphical presentation of trial results
? Works as part of a collaborative, cross-functional team with members from other disciplines
? Participates in other activities and meetings to support Biostatistics and the Development Team as needed
Requirements:
Master's degree or Ph.D. in Biostatistics or Statistics
? Five years of pharmaceutical biostatistics experience
? SAS programming experience
? Written and oral communication and presentation skills
? Proficiency with Microsoft Office (Excel, Word, Outlook)
Desired Experience:
? Experience in clinical trials through Phase 3 (NDA submission)
? Understanding of ICH GCP as well as general knowledge of industry practices and standards such as CDISC-SDTM data standardization specifications
? Experience working on ISS/ISE
? Experience working on trials in CNS therapeutic area
| Location: | 480 Arsenal Street Building 1 Watertown, MA 02472 United States |
|---|
EnVivo Pharmaceuticals
Investors: BCM Technologies, Fidelity BiosciencesAll Jobs: at EnVivo Pharmaceuticals
| Web Site: | www.envivopharma.com |
|---|---|
| Headquarters: | 480 Arsenal Street Building 1 Watertown, MA 02472 United States |
| Industry: | Biotechnology |
Support EnVivo Pharmaceuticals with Social Media services
Find more Biostatistician jobs
