Assoc Director, Statistical Programming

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Accountabilities:

• Lead and oversee statistical programming activities for clinical studies, ensuring timely and high-quality deliverables.
• Develop and/or supervise the creation of analysis datasets, tables, listings, and figures for clinical trial reporting and regulatory submissions.
• Collaborate with Clinical Development, Biostatistics, and cross-functional teams to align on study deliverables and timelines.
• Ensure programming outputs and documentation comply with internal standards, regulatory requirements, and industry best practices.
• Design, review, and validate analysis files and programming specifications for clinical data reporting.
• Support regulatory submission activities, including integrated analyses, filings, and responses to health authority queries (FDA, PMDA, etc.).
• Anticipate resource needs and manage workload prioritization across multiple concurrent projects.
• Drive process improvements and harmonization of statistical programming practices across therapeutic areas.
• Provide technical leadership and mentorship to programming team members.
• Resolve complex programming, data, and reporting issues in time-sensitive environments.

Requirements:

• Bachelor’s, Master’s, or PhD in Biostatistics, Computer Science, or a related quantitative field, with relevant pharmaceutical/biotech experience (3–10+ years depending on degree).
• Extensive experience in statistical programming within pharmaceutical or CRO environments.
• Strong hands-on expertise with SAS programming, including macros and advanced analytics.
• Deep understanding of clinical trial design, analysis, and regulatory submission requirements (FDA, PMDA, ICH, GCP).
• Advanced knowledge of CDISC standards (SDTM, ADaM, CDASH).
• Proven experience supporting regulatory submissions, integrated analyses, and post-submission activities.
• Strong ability to manage multiple complex, time-sensitive projects simultaneously.
• Excellent communication, collaboration, and stakeholder management skills.
• Strong problem-solving skills with the ability to resolve technical and operational issues independently.
• Experience in oncology, virology, hematology, or inflammation therapeutic areas is highly desirable.
• Demonstrated leadership in driving programming standards and strategic initiatives.

Benefits:

• Competitive annual salary range of approximately $177,905 to $230,230 depending on experience and location.
• Eligibility for annual discretionary bonus and long-term incentive programs.
• Comprehensive healthcare coverage including medical, dental, vision, and life insurance.
• Paid time off, holidays, and flexible work arrangements (remote eligible).
• Retirement savings plan with additional employer-supported benefits.
• Opportunity to contribute to global regulatory submissions and life-changing therapies.
• Professional growth within a highly specialized, science-driven environment.
• Exposure to advanced clinical development and global regulatory processes.

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