Job Description

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

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