Title: Director / Senior Director, Statistical Programming
Location: Greater Philadelphia Area
Job Summary: The Director/ Senior Director of Statistical Programming will lead and oversee all statistical programming functions, ensuring the delivery of high-quality support for clinical trials and regulatory submissions. This role involves strategic planning, resource management, and collaboration with cross-functional teams to achieve team and company-wide goals.
Key Responsibilities:
- Oversee the planning, execution, and delivery of statistical programming projects, ensuring timelines and quality standards are met.
- Develop and implement programming standards, guidelines, and best practices. Ensure compliance with regulatory requirements and industry standards.
- Work closely with biostatisticians, data managers, and other stakeholders to ensure seamless integration of statistical programming activities within clinical trials.
- Lead the preparation and review of programming deliverable for regulatory submissions, ensuring accuracy and completeness.
Qualifications:
- Masters in Statistics, Biostatistics, Computer Science, or a related field.
- Minimum of 8 years of experience in statistical programming within the pharmaceutical or biotechnology industry
- Proficiency in SAS, R, and other statistical programming languages.
- Strong understanding of CDISC standards (SDTM, ADaM).
- Demonstrated experience in leading a clinical asset through all phases of development
- Proven expertise in regulatory submissions, including leading and managing submission processes
- Report onsite 3 days a week