Principal Biostatistician

Entrada Therapeutics•Boston, MA

1d•$203,000 - $247,000•Remote

About The Position

Entrada Therapeutics is a clinical-stage biopharmaceutical company focused on developing a new class of medicines for intracellular targets. They are advancing a portfolio of genetic medicines for neuromuscular and inherited retinal diseases. The company has a partnership with Vertex Pharmaceuticals for a clinical-stage program for myotonic dystrophy type 1 (DM1). Entrada anticipates significant clinical milestones in 2026, including multiple data readouts for their Duchenne muscular dystrophy (DMD) programs. They are seeking colleagues who are passionate, dedicated, and ready to make a significant impact on patients' lives.

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.
Strong vendor management experience.
Excellent verbal and written communication skills, coupled with strong attention to detail and proactive mindset.

Nice To Haves

Knowledge in the latest developments in the analytical world including machine learning and artificial intelligence is a plus.
Previous experience in Neuromuscular, Ophthalmology or related TA is preferred.

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.