Senior Biostatistician, Remote (US-Based)

Entrada Therapeutics; Boston (MA); On-site; USD 140,000 - 220,000; Full time

Benefits offered by this job

Health benefits

401(k) match

Paid parental leave

Education reimbursement

Discretionary time off

Commuting benefits

Job summary

Entrada Therapeutics is seeking a senior statistician to lead daily statistical activities and shape methodologies for multiple trials. You will collaborate with internal/external teams to manage a growing portfolio and advance the biostatistics function in a fast-paced biotech environment.

Reporting to the Head of Biometrics, you will oversee deliverables, develop innovative analytical approaches, and contribute to protocols, CSRs, and publications while ensuring regulatory compliance and

Qualifications

• Ph.D. in Statistics with 6+ years in biotech/pharmaceuticals.
• Experience with a broad array of statistical approaches and proposing novel methods to accelerate clinical programs.
• Strong understanding of regulatory guidelines for drug development and statistical practice.
• Strong statistical programming skills in R, SAS, Python.
• Understanding of regulatory guidelines related to submission of datasets using CDISC, SDTM and ADaM specifications.
• Previous experience in Neuromuscular, Ophthalmology, or related therapeutic area preferred.
• Excellent verbal and written communication skills, with strong attention to detail.

Responsibilities

• Support statistical strategy for assigned drug programs, including input to clinical development plans, study concepts and protocols design, SAPs, clinical study reports, regulatory documentation and associated publications.
• Accountable for oversight of the production of biostatistics deliverables (tables, figures, listings) produced by external resources, including planned, post-hoc, and exploratory analyses.
• Provide statistical strategy support and input in protocols, CSRs, and scientific presentations and manuscripts.
• Review randomization procedures and oversight of randomization lists.
• Review study Case Report Forms, data management plans, and other data management documentation to ensure statistical requirements are met.
• Oversee outsourced statistical CRO activities and deliverables, ensuring high quality and timely delivery.
• Develop 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.

Skills

Statistical analysis

R, SAS, Python

Machine learning / AI

Verbal and written communication

Attention to detail

Cross-functional collaboration

Regulatory knowledge for drug developm

Education

Ph.D. in Statistics or related field

6+ years in statistical analysis within biotech/pharmaceuticals

Tools

CDISC SDTM/ADaM specifications

Job description

Entrada Therapeutics is seeking a senior statistician to lead daily statistical activities and shape methodologies for multiple trials. You will collaborate with internal/external teams to manage a growing portfolio and advance the biostatistics function in a fast-paced biotech environment.

Reporting to the Head of Biometrics, you will oversee deliverables, develop innovative analytical approaches, and contribute to protocols, CSRs, and publications while ensuring regulatory compliance and