Sr. Manager, Statistical Programming & Reporting

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.