Sr. Mgr / Assoc Dir, Statistical Programming & Reporting

JOB SUMMARY:

The Sr. Manager/Associate Director, Statistical Programming will support ongoing efficacy and safety analyses across entire clinical pipeline programs. This role will help with critical data interpretations used for internal decision-making and health authority interactions.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Oversee the preparation clinical and statistical reports using SAS.
• Create tables, data listings, graphs and analysis to support medical and clinical review, and to enable the data-driven operation and decision in clinical trials.
• Provide expert-level, hands-on support, and technical support to all clinical development programs and regulatory submissions
• Develop or validate programming specifications and programs to generate Study Data Tabulation Model (SDTM) and analysis datasets using ADaM standards or study-specific/submission-specific requirements
• As the owner of business intelligence, communicate with management and project teams for report requirements and specifications and standardize the basic reports in supporting the Risk-based Monitoring and solving operational or data problems for clinical trials.
• Oversee the work with study statisticians to support abstracts, posters, manuscripts and other clinical publications.
• Provide valuable input into key study documents such as Case Report Forms (CRFs), data management plans, database specifications, Statistical Analysis Plans (SAPs), and other clinical documents
• Work on oncology studies to perform safety and efficacy analysis.
• Develop SAS macros, templates and utilities for data reporting and visualization.
• Be able to write and validate SAS programs to generate tables, listings, and figures (TLFs) for clinical study reports (ICH E3 Clinical Study Reports) and analysis datasets.
• Follow best practice in programming documentation.
• Participate in establishing and maintaining statistical programming standards at Zentalis
• Other duties and projects as assigned.

EDUCATION/KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

• 8-10 years of experience in statistical programming in biotech or pharmaceutical companies.
• Minimum Bachelor’s or Master’s degree in statistic preferred, computer science with a particular focus in biostatistics considered.
• Extensive experience analyzing and interpreting clinical trial data.
• Knowledge of Medidata Rave and Oracle Inform system and clinical database structure.
• Experience in Phase 1/2/3 oncology clinical trials preferred.
• Excellent communication skills.