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Director, Biostatistics

Employer
BlueRock Therapeutics
Location
Cambridge, Massachusetts
Start date
Nov 10, 2023

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Discipline
Science/R&D, Biostatistics
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Genetown
Who is BlueRock?
BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.
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. 
  • 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
  • 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
  • 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 concept to non-statisticians
  • Experience working on all phases of clinical studies
  • Experience working on NDA/BLA/MAA development and submissions
  • A PhD degree in statistics or biostatistics with at least 6 years’ experience in clinical trials with a pharmaceutical sponsor.
  • #LI-AL1
    BlueRock Therapeutics Company Culture HighlightsWinner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023Winner of Comparably's Award for Best Company for Diversity 2022Winner of Comparably's Award for Best Company for Women 2022Winner of Comparably's Award for Best CEO 2022BlueRock 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-therapeuticsFollow 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.

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