Provide statistical leadership in clinical development, design trials, consult on statistical methods, and ensure regulatory compliance for clinical programs.
This position will provide statistical strategic leadership in one or more therapeutic areas, including contribution to clinical development plans, protocol designs, statistical simulations, and regulatory interactions. Reporting to the Head of Biometrics, this position will also provide guidance to data management and statistical programming in data collection and analysis to support clinical programs within BlueRock, participate in the SOP development as well as oversee the activities of external vendor biostatistics teams to ensure deliverables are met with quality.
Responsibilities:
- Biostatistics representative in the Clinical Strategy Team
- 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
- Develops and implements innovative statistical methodologies such as Bayesian methods and adaptive designs for clinical trials and research studies.
- 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
- Biostatistics representative in regulatory interactions for assigned programs
- Provides education and training on statistical methods and keeps up to date on the latest developments in statistical methodologies in clinical research
- Writes statistical sections of the clinical trial protocols
- Provides statistical support and oversight of Data Monitoring Committees and Independent Statistical Analysis Centers.
- Contributes to clinical study reports and regulatory documents
- Contributes to the Biometrics SOPs development
- Participates in other activities and meetings to support Biometrics as necessary
Minimum Requirements:
- Excellent interpersonal and influencing skills
- A good team player with excellent strategic thinking skills
- Demonstrated ability to communicate complex statistical concepts to non-statisticians
- Extensive experience with Statistical software (e.g. SAS, R) and CDISC standards Experience working on NDA/BLA/MAA development and submissions. Strong understanding of regulatory requirements and guidelines (e.g. FDA, EMA)
- A PhD degree in statistics or biostatistics with at least 6 years’ experience or a master’s degree in Statistics or Biostatistics with at least 8 years’ experience in clinical trials with a pharmaceutical sponsor.
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BlueRock Therapeutics Cambridge, Massachusetts, USA Office
1 Broadway, , Cambridge, MA, United States
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