23 May Associate Director, Non-clinical Biostatistics
Associate Director, Non-clinical Biostatistics
Development – Biometrics · Cambridge, Massachusetts · Full time
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 to support non-clinical areas within BlueRock.
The candidate for this position must be a motivated and experienced statistician with a solid background in nonclinical statistics, strong consulting skills, and an interest in collaborating with research scientists in cell therapy discovery and development. Reporting to the Head of Biometrics, the candidate will work closely with non-clinical scientists seeking to discover new cell therapies in a variety of therapeutic areas by providing statistical support for all preclinical areas.
Responsibilities:
- Collaborates with preclinical scientists to design, analyze, and present experiments.
- Brings innovative statistical thinking and methods to help drive the enhanced quantitative solutions, and ensure rigorous approaches are taken with sound statistical methods and documented in protocols, analysis plans and manuscripts.
- Works with scientists to understand the scientific questions and develop “fit-for-purpose” statistical solutions.
- Represents Biostatistics in the Non-Clinical Strategy Team
- Provides key contributions to the non-clinical development strategy and plan including but not limited to design options, simulations to evaluate operating characteristics of study designs
- Collaborates with external statistical experts and consultants to provide innovative solutions
- Provides statistical expertise on regulatory submissions and ensure quality of deliverables.
- Uses statistical expertise to prepare both internal and external reports, regulatory interactions, presentations, and manuscripts, with the aim to improve the quality of internal decision making.
- Standardizes processes and methodologies in preclinical statistics.
- Develops statistical tools to make analyses efficient.
- Provides education and training on statistical methods and keeps up to date on the latest developments in statistical methodologies in nonclinical research.
- May contribute to the Biometrics SOPs.
- Participates in other activities and meetings to support Biometrics as necessary.
Minimum Requirements:
- PhD in Statistics/Biostatistics and at least 3-4 years of pharmaceutical experience or a MS in Statistics/Biostatistics and at least 5+ years of pharmaceutical experience.
- Strong preclinical and non-clinical statistics experience is required.
- Must have strong technical competence.
- Excellent interpersonal and influencing skills
- A good team player with excellent strategic thinking skills
- Good computational skills in SAS, or R.
- Demonstrated ability to communicate complex statistical concept to non-statisticians
- Capabilities to provide statistical leadership to cross-functional teams.
- Good knowledge of drug development regulations pertinent to statistical analysis
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BlueRock Therapeutics Company Culture Highlights
- 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
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.
Please click here to apply.
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