Skip to main content
Entrada Therapeutics

Biostatistician Lead Consultant

RemoteUnited States only
Published
Role
Data Science
Experience
Lead
Employment
Part-time20–25h/week
Salary not disclosed
Check eligibility

Open to US only. Set where you work from to check your eligibility.

No BS summary

Lead biostatistics consultant for clinical trial drug programs, 10+ years in biotech/pharma statistical analysis and a Ph.D. in Statistics or related field. Must be US-based remote, long-term contract, 20–25 hours/week. Needs R, SAS, Python, CDISC/SDTM/ADaM, regulatory submissions, vendor/CRO oversight, and rare disease clinical program experience.

Core skills

RSASBiostatistics

Required skills

PythonCDISCSDTMADaM

What you'll do

  • 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 they require

  • 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.
  • Preferred: 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.

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.

🇺🇸 United StatesBiopharmaceuticalsStartupentradatx.com
Salary not disclosed