Key Responsibilities:
Leadership and Strategy:
- Provide visionary leadership to shape and execute statistical programming strategies aligned with project objectives.
- Collaborate seamlessly with cross-functional teams to ensure a cohesive approach to programming in clinical development programs.
Team Management:
- Lead, mentor, and foster the professional development of a team of statistical programmers.
- Implement effective resource allocation and workload management strategies to optimize team performance.
Technical Expertise:
- Oversee and contribute to the development and validation of statistical programs for various clinical studies.
- Offer subject matter expertise in statistical programming methodology and adhere to industry standards.
Quality Assurance:
- Ensure rigorous compliance with regulatory requirements and uphold the company's quality standards.
- Conduct thorough quality control checks on statistical outputs to guarantee precision and reliability.
Collaboration:
- Foster collaborative relationships with biostatisticians, data managers, and other cross-functional teams to facilitate the seamless integration of statistical programming activities.
Continuous Improvement:
- Identify opportunities for process enhancement and spearhead the implementation of best practices.
- Stay abreast of industry developments, contributing to the ongoing evolution of departmental capabilities.
Qualifications:
- Master's in statistics, biostatistics, or a related field.
- Extensive experience in statistical programming within the pharmaceutical industry.
- Proficiency in SAS programming and other relevant statistical programming languages.
- Proven leadership and people management skills.
- In-depth knowledge of regulatory requirements related to statistical programming in clinical trials.