Principal Biostatistician

Entrada Therapeutics•Boston, MA

2d•$190,000 - $231,000•Remote

About The Position

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. 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. You are results-oriented and collaborative, and you thrive when build strong relationships across teams to deliver impactful solutions. Reporting to the Senior Director, Biometrics, this individual will contribute to daily statistical activities and support the development of statistical approaches for clinical trials. Working closely with internal and external stakeholders, you will help manage a growing portfolio of trials. This role also offers the opportunity to support the continued growth of the biostatistics function at Entrada and gain valuable experience in a collaborative, fast-paced environment.

Requirements

Ph.D. in Statistics or a related field, with 6 + 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.
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.
Excellent verbal and written communication skills with a strong attention for detail.

Nice To Haves

Knowledge in the latest developments in the analytical world including machine learning and artificial intelligence is a plus.
Previous vendor management experience is preferred.
Previous experience in Neuromuscular, Ophthalmology or related TA is preferred.
This is a US based remote position, with preference given to local New England based candidates.
This role will require a minimum quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA.

Responsibilities

Support 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.
Provide statistical strategy support and input in protocols, CSRs, and scientific presentations and manuscripts.
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.
Produce innovative tools and methodologies for statistical analysis through literature review.
Participate in the development of department strategies and cross functional initiatives on standards, infrastructure, and processes.