Key Responsibilities
- Leadership and Management: Lead and mentor a team of statisticians, fostering a collaborative and innovative work environment. Provide guidance on statistical methodologies and best practices.
- Statistical Strategy: Develop and implement statistical strategies for clinical trials, ensuring alignment with regulatory requirements and industry standards.
- Collaboration: Work closely with cross-functional teams, including clinical operations, regulatory affairs, and data management, to ensure seamless integration of statistical analysis into project workflows.
- Bid Defense Participation: Participate in bid defenses, offering statistical expertise and presenting sample size calculations to support the company’s proposals.
- Client Interaction: Serve as the primary statistical contact for clients, providing expert advice and support throughout the project lifecycle.
- Quality Assurance: Ensure the accuracy and integrity of statistical analyses and deliverables. Oversee the preparation of statistical reports and presentations for clients and regulatory submissions.
- Continuous Improvement: Stay current with industry trends and advancements in statistical methodologies. Identify opportunities for process improvements and implement best practices within the team.
Qualifications
- Education: Ph.D. in Biostatistics, Statistics, or a related field.
- Experience: Minimum of 8 years of experience in biostatistics, with at least 3 years in a leadership role within a CRO or pharmaceutical company.
- Technical Skills: Proficiency in statistical software (e.g., SAS, R, or similar) and a strong understanding of clinical trial design and analysis.
- Regulatory Knowledge: Familiarity with regulatory guidelines (FDA, EMA, ICH) and experience in preparing statistical sections for regulatory submissions.
- Communication Skills: Excellent verbal and written communication skills, with the ability to convey complex statistical concepts to non-statistical audiences.
Interested candidates should submit their resume and a cover letter to Anna Bashmakova at anna.bashmakova@palleos.com