Biostatistician Lead Consultant

Posted 13 Days Ago
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Boston, MA, USA
In-Office
Expert/Leader
Biotech • Pharmaceutical
The Role
Lead and support statistical strategy for clinical trials, author SAPs and regulatory documents, oversee outsourced CRO biostatistics deliverables (TFLs), review randomization procedures, and manage vendor relationships. Part-time long-term contract (~20-25 hours/week) supporting rare-disease programs and regulatory submissions.
Summary Generated by Built In
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. Through proprietary and versatile approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy (DMD) who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered with Vertex Pharmaceuticals to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1 (DM1).

2026 represents a catalyst-rich period for Entrada. We expect multiple clinical data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four clinical-stage programs in our DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51). These programs are complemented by the ongoing clinical progress of our DM1 collaboration with Vertex (VX-670).

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 passionate about clinical trial research and driven to advance drug development through rigorous analytics. With a strong foundation in statistics and clinical methodologies, you combine classical techniques with cutting-edge innovations. You thrive in fast-paced settings, handle competing priorities with ease, and eagerly step in where needed.

The Opportunity

Reporting to the Head of Biometrics, this individual will lead daily statistical activities and support the development of statistical approaches for clinical trials in a part-time capacity of about 20 hours per week.

Responsibilities
  • Support or lead 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 external resources.
  • Review the randomization procedures and oversight of the production of randomization lists.
  • Oversee outsourced statistical CRO activities and deliverables, ensuring high quality and timely delivery.
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:

  • Ph.D. in Statistics or a related field, with 10 + years of experience in statistical analysis within the biotech/pharmaceutical industry.
  • Experience with a broad array of statistical approaches and experience in proposing novel approaches to support acceleration of clinical programs, specifically within rare disease indications.
  • Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical practice.
  • Strong statistical programming skills (R, SAS, Python).
  • Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications.
  • Strong vendor management experience.
  • Previous experience in Neuromuscular, Ophthalmology or related TA is preferred.
  • Excellent verbal and written communication skills, coupled with strong attention to detail and proactive mindset.
  • This is a long-term contract position based remotely in the US, with preference given to local New England based candidates. This role is for an expected 20-25 hours per week. #LI-JF1 #LI-Remote
Equal Opportunity Employer

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.

Skills Required

  • Ph.D. in Statistics or related field with 10+ years of statistical analysis experience in biotech/pharmaceutical industry
  • Experience proposing and applying a broad array of statistical approaches, including novel methods for rare disease indications
  • Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical practice
  • Strong statistical programming skills (R, SAS, Python)
  • Understanding of CDISC standards and development of SDTM and ADaM specifications
  • Experience overseeing biostatistics deliverables (TFLs) and reviewing randomization procedures
  • Strong vendor/CRO management experience
  • Previous experience in Neuromuscular, Ophthalmology, or related therapeutic area
  • Excellent verbal and written communication skills, attention to detail, and proactive mindset
  • Ability to work part-time (~20-25 hours per week) on a long-term contract, remote in the US (preference for New England)
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The Company
HQ: Boston, MA
122 Employees
Year Founded: 2016

What We Do

Headquartered in Boston’s Seaport community, Entrada Therapeutics is a growing biopharmaceutical company innovating to transform the treatment of devastating diseases through intracellular therapeutics. We’re establishing a new class of medicines, Endosomal Escape Vehicles (EEV™), with the potential to engage intracellular targets that have long been considered inaccessible and undruggable. Our EEV™ therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues with an improved therapeutic index. Through our proprietary, highly versatile, and modular EEV™ Platform, we are building a robust development portfolio of oligonucleotide-, antibody- and enzyme-based programs for the potential treatment of neuromuscular diseases, immunology, oncology, and diseases of the central nervous system. For more information about Entrada, please visit www.entradatx.com.

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