Zeno Management, Inc. seeks a Senior Manager, Statistical Programming and Reporting in San Diego, California or remote anywhere in the U.S. The Senior Manager, Statistical Programming and Reporting will utilize their experience working in a statistical programming position for pharmaceutical or biotechnology clinical research and/or development to 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.
Specific responsibilities for the role include:
- Preparing clinical and statistical reports using SAS;
- Creating tables, listings, figures (TLFs) and analysis datasets to support medical and clinical review, and to enable the data-driven operation and decision in oncology-related clinical trials;
- As the owner of business intelligence, communicating 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;
- Working with study statisticians to support abstracts, posters, manuscripts and other oncology related clinical publications;
- Understanding Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards and regulatory requirements;
- Creating SDTM/ADaM datasets while following CDISC standards;
- Developing independent programs to validate analysis datasets and TLFs generated by vendors, ensuring compliance with CDISC and submission requirements;
- Working on oncology studies to perform safety and efficacy analysis; and
- Developing and maintaining SAS programming macros, templates and utilities to support internal data review, monitoring, data reporting and visualization.
Education Requirement:
Bachelor’s degree or foreign equivalent in pharmacy, statistics, or a related field.
Experience Requirement:
Five (5) years of experience working in a statistical programming position for pharmaceutical or biotechnology clinical research and/or development.
Three (3) years of experience in:
- Creating SDTM/ADaM datasets while following CDISC standards;
- Creating Tables, Data Listings, and Figures (“TLFs”);
- Developing independent programs to validate analysis datasets and TLFs generated by vendor while ensuring compliance with CDISC and submission requirements; and
- Developing and maintaining SAS programming macros to support internal data review and monitoring.
Experience must also include two (2) years of experience working on oncology-related projects.
Travel:
None. This position permits teleworking/remote working anywhere in the U.S.
Pay:
Pay is $164,000 to $180,000, depending on experience.
Employer Contact:
To apply, email resume to Sheena Delgado ([email protected]) referencing REQ 211017.
Top Skills
What We Do
Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing azenosertib (ZN-c3), a potentially first-in-class and best-in-class WEE1 inhibitor for patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC). Azenosertib is being evaluated as a monotherapy and in combination across multiple tumor types in clinical trials and has broad franchise potential. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types. The Company is also leveraging its extensive experience and capabilities to translate its science to advance research on additional areas of opportunity for azenosertib outside PROC.
