Senior Manager, Publications Systems & Operations
BeOne Medicines
Associate Director, Biostatistics
BlueRock Therapeutics
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts
Visit company websiteJob Level
Senior
Tech Stack
Go
About the role
- 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.
- Biostatistics representative in the Clinical Study Team
- Provides key contributions to the clinical development strategy and plan including but not limited to dose-finding strategy, design options, simulations to evaluate operating characteristics of study designs, and Go/No Go decisions.
- Provides technical leadership in the design, execution of clinical trials and statistical analysis plans.
- Plan and execute of exploratory analysis and statistical consultation within cross-functional teams.
- Generates and/or verifies sample size calculations and randomization schedules as needed
- Propose and implement innovative designs and methods to optimize drug development.
- Authors 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
- Lead statistical oversight of CROs to ensure timely, high-quality deliverables aligned with regulatory standards and clinical development objectives
- Effective partnership with other functions to ensure integrated quantitative input into project
- Participates in other activities and meetings to support Biometrics as necessary
Requirements
- A PhD degree in statistics or biostatistics with at least 6 years’ experience in clinical trials with a pharmaceutical sponsor
- Has advanced knowledge of applying statistics and innovative approaches expert knowledge in various statistical areas
- Excellent interpersonal and influencing skills
- A good team player with excellent strategic thinking skills
- Demonstrated ability to communicate complex statistical concepts to non-statisticians
- Experience working in early phases of clinical studies
