Director, Biostatistics | Cambridge, Massachusetts, United States | BlueRock Therapeutics

Position:	Director, Biostatistics
Institution:	BlueRock Therapeutics
Location:	Cambridge, Massachusetts, United States
Duties:	Provides key contributions to the clinical development strategy and plan including but not limited to design options, simulations to evaluate operating characteristics of study designs, and probabilities of Go/No Go decisions; Collaborates with external statistical experts and consultants to provide innovative solutions to clinical study designs; Provides technical leadership in the design and execution of clinical trials and statistical analysis plans; Provides statistical consulting to other functions within development; Generates and/or verifies sample size calculations and randomization schedules as needed
Requirements:	A PhD degree in statistics or biostatistics with at least 6 years’ experience in clinical trials with a pharmaceutical sponsor; Experience working on NDA/BLA/MAA development and submissions; Experience working on all phases of clinical studies

Text:	Director, Biostatistics Provides key contributions to the clinical development strategy and plan including but not limited to design options, simulations to evaluate operating characteristics of study designs, and probabilities of Go/No Go decisions; Collaborates with external statistical experts and consultants to provide innovative solutions to clinical study designs; Provides technical leadership in the design and execution of clinical trials and statistical analysis plans; Provides statistical consulting to other functions within development; Generates and/or verifies sample size calculations and randomization schedules as needed A PhD degree in statistics or biostatistics with at least 6 years’ experience in clinical trials with a pharmaceutical sponsor; Experience working on NDA/BLA/MAA development and submissions; Experience working on all phases of clinical studies