Principal Biostatistician

Role Description

Reporting to the Head of 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.

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.

Qualifications

• 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.
• Knowledge in the latest developments in the analytical world including machine learning and artificial intelligence is a plus.
• 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.

Requirements

• 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.

Benefits

• Comprehensive health, dental and vision coverage.
• Life and disability insurance.
• 401(k) match.
• Paid, gender-inclusive parental leave.
• Holistic support for health and well-being.
• Education reimbursement.
• Discretionary time off.
• Commuting benefits aligned to your working model.