Sr. Mgr

2 weeks ago

New York, United States Zentalis Full time
Job DescriptionJob DescriptionSalary: $155-180k

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.

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