Biostatistician Lead Consultant

Role Description

Reporting to the Head of Biometrics, this individual will lead daily statistical activities and support the development of statistical approaches for clinical trials in a part-time capacity of about 20 hours per week.

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.

Qualifications

• 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.
• 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.

Benefits

• 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.

Equal Opportunity Employer

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.

Third Party Staffing Agencies

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