What are the responsibilities and job description for the Principal Statistician position at Infotree Global Solutions?
Key Responsibilities:
- Serve as the statistical leader in a cross-functional development team, providing expertise in the development and implementation of clinical programs for one compound/indication.
- Contribute to the development strategy and decision-making by interpreting clinical trial data, ensuring robust statistical methodologies are applied.
- Collaborate closely with program partners and stakeholders to deliver high-quality statistical outputs for clinical trials and/or health authority (HA) submissions.
- Ensure all functional responsibilities are carried out in compliance with company guidelines and regulatory standards.
- Report to the Disease Area Team Leader, contributing to the broader biostatistics and statistical modelling efforts within the organization.
Qualifications and Skills:
- Education: Master’s or Ph.D. in Statistics, Biostatistics, or a related field.
- Experience:
- Ph.D.: Minimum 6 years of experience in a regulatory drug development environment.
- Master’s: Minimum 8 years of experience (including relevant doctoral research in biostatistics).
- Industry Expertise: Extensive experience in the pharmaceutical or biotech industry (not in a CRO) with a deep understanding of regulatory drug development.
- Technical Expertise:
- Proficiency in advanced biostatistics and its application to clinical trials.
- Expertise in Bayesian statistical methods and clinical trial design, including scenario planning.
- Strong knowledge of statistical software, including SAS and R.
Salary : $58 - $77
