Senior Manager, Statistical Programming & Analysis

Role Summary

Senior Manager, Statistical Programming & Analysis, responsible for the management and oversight of programming activities in support of the brelovitug program. The role provides operational oversight of statistical programming vendors and performs in-house programming for clinical trial analysis, regulatory filings, and internal decision-making processes. It collaborates with cross-functional teams to ensure data quality, regulatory compliance, and timely analysis delivery.

Responsibilities

• Provide programming expertise in support of statistical analysis across multiple clinical trials for inclusion in clinical study reports, regulatory submissions, periodic reporting, and publications.
• Perform oversight of statistical programming vendors to ensure quality and on-time delivery of programming packages.
• Develop and maintain CDISC-compliant and submission-ready SAS programs, SDTM, ADaM and summary tables and figures.
• Work collaboratively with multiple stakeholders to manage priorities and resources; understand and perform in accordance with regulatory standards and drug development principles.
• Monitor and evaluate ongoing clinical trial data and contribute to the resolution of data discrepancies.
• Contribute to overall Biometrics group in developing innovative processes to ensure high data quality and efficient reporting of analysis results.
• Ensure proper filing of study documentation consistent with regulatory compliance and conducive to inspection readiness.
• Take on initiative to stay current on relevant technologies, industry standards and guidelines to improve programming efficiency and facilitate review of clinical trial data.
• Other duties as assigned.

Qualifications

• 5+ years of experience as a statistical programmer within the biotech/pharmaceutical industry with at least 2 years of demonstrated study lead programming experience and career progression.
• Experience in effectively managing statistical programming vendors and/or internal statistical programming resources for the purposes of clinical trial reporting, regulatory filings, and key internal deliverables.
• Experience in regulatory GCP inspections/audits is a plus.

Education

• Master’s degree in statistics, biostatistics, data science, or a closely related field preferred.

Skills

• Advanced SAS programming skills in performing clinical trial data analysis and reporting.
• Strong analytical skills and demonstrated experience in gathering, interpreting, and analyzing data in clinical research and drug development.
• Working knowledge of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
• Strong communication skills, ability to develop rapport among cross-functional stakeholders, and passion to analyze complex issues to develop relevant and realistic programming solutions.
• Ability to at times take initiative to work with minimal supervision and efficiently adjust workload based upon changing priorities.