Director, Biostatistics

The Perfect Addition to Our Team

You are excited about the opportunity to lead biostatistics and support the progress of our clinical trials here at Entrada. You are well organized and will be able to independently provide strategic statistical input to drug development planning. You enjoy a fast-paced environment and juggling competing priorities and are willing to jump in and help wherever it is needed. You drive for results, efficiently connecting problems with solutions. You work successfully in a team environment and have strong interpersonal skills, to effectively build working relationships inside and outside of the company.

The Opportunity

Reporting to the SVP, this individual will guide day-to-day statistical operations and the development of statistical methodologies. You will work with internal and external stakeholders to support and oversee a portfolio of clinical studies.  The individual will support the strategic growth of the biostatistics function at Entrada. 

Responsibilities

• Responsible for leading statistical strategy for assigned drug programs, including input to clinical development plans, clinical study concepts and protocols design, SAPs, clinical study reports, regulatory documentation and associated publications.
• Accountable for oversight of the production of biostatistics deliverables (TFLs, including planned, post-hoc, and/or exploratory analyses) as performed by internal and/or external resources.
• Serve as a key leader in the clinical product team, providing statistical strategy and inputs in protocols, data monitoring committee (DMC) charters, clinical study reports (CSR) and other study-level documents.
• Serve as the biostatistical lead to support the team to design and support data collection, analyses, interpretation of efficacy, safety, and biomarker results.
• Author/review the statistical analysis plan for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and authors or oversees the development of shells for tables, figures and listings.
• Define/review the randomization procedures and oversight of the production of randomization lists.
• Review study Case Report Forms, data management plan and other data management related documentation to ensure that specific statistical requirements defined in the study protocol are met.
• Oversee outsourced statistical CRO activities and deliverables, ensuring high quality and timely delivery.
• Support and participate in the development of department strategies and cross functional initiatives on standards, infrastructure and processes.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
• Creativity - We are creative problem solvers.
• Collaboration - We are more than the sum of our parts.
• Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

• PhD with 10 + years or MS and 12 + years of relevant statistical analysis roles in the biotech/pharmaceutical industry is required.
• Experience with a broad array of statistical approaches and experience in proposing novel approaches to support acceleration of clinical programs in rare disease trials.
• Demonstrated track record in various disease indications, endpoints and appropriate statistical/regulatory requirements.
• Experience in supporting responses and submissions to health authorities (FDA, EMA).
• Strong vendor management and oversight experience.
• Proficiency in statistical analysis software (SAS and R) and sample size calculation software (e.g. EAST and/or NQuery).
• Excellent verbal and written communication skills.
• This is a US based remote position, with preference given to local New England based candidates. This role will require minimum quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA. 

Preferred Skills:

• Direct line people management.
• Deep understanding of Biomarkers, PK/PD, PRO and RWE.
• Neuromuscular drug development experience. #LI-Remote LI-JF1