New

Associate Director, Biostatistics

BlueRock Therapeutics
United States, Massachusetts, Cambridge
238 Main Street (Show on map)
Aug 26, 2025
Who is BlueRock? BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson's disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. What Are We Doing? Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients' lives. 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 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 Minimum 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 #LI-AL1 BlueRock Therapeutics Company Culture Highlights Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023 Winner of Comparably's Award for Best Company for Diversity 2022 Winner of Comparably's Award for Best Company for Women 2022 Winner of Comparably's Award for Best CEO 2022 BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably. Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably. Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics Follow us on Linkedin: https://www.linkedin.com/company/bluerocktx/ Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.