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Senior Director of Biostatistics and Biometrics
2 months ago
The Senior Director of Biostatistics and Biometrics will be responsible for establishing and leading the Biometrics function within Planet Pharma.
This role will report directly to the Chief Development Officer and will be critical in developing the strategy, systems, and processes necessary to support clinical development programs, regulatory submissions, and overall data-driven decision-making.
The ideal candidate will have deep expertise in biostatistics, data management, and statistical programming, coupled with strong leadership skills and experience building high-performing teams.
Key Responsibilities:- Develop and execute the global biometrics strategy in alignment with the company's clinical development and regulatory goals.
- Establish and lead the biometrics function, including biostatistics, data management, and statistical programming, ensuring integration across all clinical programs.
- Provide strategic input into the design and execution of clinical trials, ensuring robust statistical methodologies are applied.
- Build and lead a high-performing biometrics team, fostering a culture of excellence, collaboration, and innovation.
- Oversee the development, implementation, and maintenance of biometrics processes and systems, ensuring data integrity and compliance with regulatory standards.
- Lead the planning and execution of statistical analyses, ensuring accurate and timely delivery of high-quality data for clinical trials and regulatory submissions.
- Ensure all biometrics activities comply with global regulatory requirements, including FDA, EMA, and other international health authorities.
- Lead the statistical aspects of regulatory submissions, including the preparation of statistical analysis plans (SAPs), clinical study reports (CSRs), and responses to regulatory inquiries.
- Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, and other cross-functional teams to ensure seamless integration of biometrics into the clinical development process.
- Provide expert statistical consultation and guidance to internal stakeholders, supporting data-driven decision-making across the organization.
- Advanced degree in biostatistics, statistics, mathematics, or a related field (PhD strongly preferred).
- A minimum of 10 years of experience in biostatistics and biometrics within the biopharmaceutical industry.
- Extensive experience with global regulatory requirements and submissions, including FDA and EMA guidelines.
- Proven track record of building and leading successful biometrics teams and functions.
- Strong strategic and analytical thinking, with the ability to develop and execute comprehensive biometrics strategies.
- Expertise in statistical methodologies and clinical trial design, with a deep understanding of the biopharmaceutical industry.
- Excellent leadership and team-building skills, with the ability to inspire and motivate a diverse team.
- Superior communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders, including regulatory authorities.
