Biostatistician Lead Consultant

Entrada Therapeutics • Boston, MA

8d • Remote

About The Position

Entrada Therapeutics is a clinical-stage biopharmaceutical company focused on developing a new class of medicines for intracellular targets. The company is advancing a portfolio of genetic medicines for neuromuscular and inherited retinal diseases. Entrada has a catalyst-rich period approaching, with multiple clinical data readouts expected by 2026 for its Duchenne muscular dystrophy (DMD) programs and its collaboration with Vertex Pharmaceuticals for myotonic dystrophy type 1 (DM1). Entrada is seeking to grow its team with dedicated individuals who are ready to make a significant impact on patients' lives.

Requirements

• 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.
• Excellent verbal and written communication skills, coupled with strong attention to detail and proactive mindset.

Nice To Haves

• Previous experience in Neuromuscular, Ophthalmology or related TA is preferred.

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.

What This Job Offers

• Job Type: Part-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree