Part Time Remote Developer Jobs in Massachusetts

You are passionate about clinical trial research and driven to advance drug development through rigorous analytics. With a strong foundation in statistics and clinical methodologies, you combine classical techniques with cutting-edge innovations. You thrive in fast-paced settings, handle competing priorities with ease, and eagerly step in where needed.

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.

• 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.

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
• Creativity - We are creative problem solvers.
• Collaboration - We are more than the sum of our parts.
• Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

• 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.
• 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. #LI-JF1 #LI-Remote