Director, Biostatistics

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Job description

The Organization

What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.

Our Endosomal Escape Vehicle (EEV )-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological diseases, among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable. We have also partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.

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-JF1

The Perks

By becoming a team member here at Entrada, you'll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.

Third Party Staffing Agencies

Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.

Privacy Statement

Entrada Therapeutics, Inc. (the "Entrada," "we," "us," or "our") respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information. Please reference our privacy statement here to understand how and when your data is being used.

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