Associate Director, Statistical Programming

As Associate Director, Statistical Programming, this role provides statistical programming support for compounds at various stages of development, including clinical trials, regulatory filings, and commercialization. Reporting to the Director, Statistical Programming Lead, the role involves:

Responsibilities:

• Serve as the study lead programmer for assigned clinical trial(s), collaborating with study statisticians, data management, and other team members to provide statistical programming support.
• Review and ensure the quality of Define packages, including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML for assigned clinical trials.
• Ensure compliance with CDISC standards and regulatory requirements for integrated datasets during electronic submissions.
• Work closely with the study lead biostatistician to manage vendor deliverables, ensuring quality and adherence to timelines.
• Perform independent validation (QC) to verify the accuracy of statistical vendor deliverables, datasets, and analytic outputs.
• Validate analytic outputs produced by internal biostatisticians or statistical programmers.
• Collaborate with the Clinical Data Management group to produce systematic data reports for efficient clinical trial data review and cleaning.
• Review CRF and/or Data Transfer Specifications to ensure data collection meets study objectives, requirements, and CDISC standards.
• Provide input to Statistical Analysis Plans and TLF Shells for Tables/Listings/Figures.
• Conduct statistical analyses to support publications and regulatory correspondence as needed.
• Perform other duties as assigned.

Qualifications and Skills:

• A Master’s Degree in Biostatistics, Statistics, Computer Science, or a related field with at least 12 years of experience in statistical programming support within clinical trials.
• Deep understanding of data standards and experience in Pinnacle 21 validation reports and creating Define XML packages for regulatory filings.
• Proficient in statistical computational software such as SAS, including complex data steps, SAS macro languages, and commonly used analysis procedures (e.g., PROC Freq, PROC REPORT, PROC GLM, PROC MIXED).
• Demonstrated ability to collaborate with biostatisticians, Clinical Data Management, and colleagues across functions to achieve common goals.
• Strong organizational and project management skills, with a demonstrated interest in continuous learning and growth.
• Proven ability to work effectively on multiple projects in a fast-paced environment.
• Detail-oriented with high standards for excellence in statistical programming deliverables.
• Effective communication and teamwork skills, particularly in a work-from-home environment.

Preferred Experience:

• Experience in data structure and data analysis in CNS (Central Nervous System) clinical trials.
• Experience in providing integrated data analysis support for regulatory filings.