Senior Manager, Statistical Programming

Role Summary

Senior Manager, Statistical Programming role focused on driving the development and validation of statistical programs for late-stage clinical studies. Ensure programming activities align with SOPs and regulatory requirements, delivering high-quality and timely results. This role contributes to critical drug development efforts while driving efficiency and compliance in statistical programming. Location: South San Francisco, CA.

Responsibilities

• Lead the development and validation of statistical programs to ensure high-quality deliverables for both in-house and outsourced projects, adhering to company and regulatory requirements.
• Drive ISS/ISE analysis tasks in support of NDA submissions.
• Assist in planning and coordinating project work to ensure timely and high-quality delivery across multiple studies.
• Develop and review programming plans, dataset specifications, and TLFs; apply expertise in CDISC standards, including SDTM and ADaM models.
• Review documents produced by biometric functions such as SAPs, CRFs, data review plans, and data transfer agreements.
• Oversee CRO programming activities, reviewing and validating CRO deliverables including SDTM, ADaM and TLFs, while providing solutions to any issues raised by CROs.
• Review eSubmission datasets and data documentation such as aCRF, reviewer guides, define documents and programs to ensure all files meet submission requirements.
• Develop macros to support study and project activities, contributing to global macro tools that enhance the overall efficiency and capacity of the programming function.
• Maintain deep familiarity with ICH guidelines and advanced knowledge of regulatory submission requirements, ensuring all statistical programming deliverables meet industry and company standards.
• Support the preparation of clinical study reports, regulatory submissions, DSURs, and safety reports across multiple studies.
• Contribute to the development, implementation and continuous improvement of programming processes and standards.
• Communicate effectively within project teams, across departments, and with external collaborators.

Qualifications

• Expert-level SAS programmer with a proven track-record of delivering complex programming assignments and analyses.
• Skilled in writing original cold, developing macros and modifying existing code.
• Experience in developing and implementing statistical programming standards and procedures.
• Expert level knowledge and extensive hands-on experience with CDISC standards including CDASH, SDTM, and ADaM.
• Experience leading teams supporting FDA, EMEA, and CDE regulatory filings.
• Strong interpersonal skills with excellent written and verbal communication.
• Meticulous attention to detail and consistency.

Education

• Bachelor’s degree (or equivalent), preferably in a computational or biological science, with a minimum of 8 years of direct experience in drug development.
• Master’s degree with minimum of 6 years of related experience.