Title: Associate Director / Director, Statistical Programming
Location: Philadelphia
Job Summary: The AD/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:
- Master's in Statistics, Biostatistics, Computer Science, or a related field.
- Minimum of 10 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).
- Proven ability to lead and motivate teams, manage complex projects, and drive strategic initiatives.
- Report onsite 4 days a week
