Principal Biostatistician
E
Entrada TherapeuticsBiopharmaceutical
This is a US based remote positionFull-TimePrincipal
Salary203,000 - 247,000 USD per year
Apply NowOpens the employer's application page
Job Details
- Experience
- 6+ years
- Required Skills
- PythonR
Requirements
- Ph.D. in Statistics or a related field.
- 6+ years of experience in statistical analysis within the biotech/pharmaceutical industry.
- Strong statistical programming skills (R, SAS, Python).
- Solid understanding of regulatory guidelines on drug development and regulatory submissions.
- Knowledge of CDISC, SDTM, and ADaM datasets and specifications.
- Strong vendor management experience.
- Experience with a broad array of statistical approaches; machine learning/AI knowledge is a plus.
- Previous experience in Neuromuscular, Ophthalmology or related therapeutic area preferred.
- Excellent verbal and written communication skills with strong attention to detail.
- Proactive mindset.
Responsibilities
- Support statistical strategy for assigned drug programs, including input to clinical development plans, study protocols, SAPs, CSRs, and regulatory documents.
- Accountable for oversight of biostatistics deliverables (TFLs) produced by external resources.
- Provide statistical strategy support for scientific presentations and manuscripts.
- Review randomization procedures and lists.
- Review Case Report Forms and data management documentation to ensure protocol alignment.
- Oversee outsourced statistical CRO activities and ensure quality and timeliness.
- Produce innovative analytical tools and methodologies via literature review.
- Participate in departmental strategy and infrastructure initiatives.
View Full Description & ApplyYou'll be redirected to the employer's site
