Senior Manager, Statistical Programming

Role Summary

We are seeking a Senior Manager, Statistical Programming, who will report into the Director, Statistical Programming. You will be responsible for providing technical expertise, and oversight of programming by CRO partners for the analysis and reporting of clinical study data in accordance with departmental SOPs and regulatory guidelines. This role is also responsible for hands-on generation of analysis results for rapid responses, ad hoc analyses, exploration of biomarkers, etc.

The Senior Manager of Statistical Programming will work as part of a multidisciplinary team, providing programming support for clinical trials. The Statistical Programmer will execute on the preparation, production, validation, reporting, and documentation of statistical programming activities internally and externally (CRO). They will demonstrate state-of-the-art programming knowledge/skills, develop datasets and analysis result displays for study monitoring and clinical study reports and develop analysis datasets to support exploratory analyses and data analytics for biomarkers, publications, and/or modeling work.

The successful candidate will effectively design and develop SAS programs to execute statistical analysis and produce clinical trial reporting deliverables, including tables, listings, graphs for clinical study reports, displays for publications, interim and/or ad hoc analysis, and submission-ready data in alignment with assigned clinical plans and strategies. This role will develop and perform appropriate quality control and validation of output in support of assigned clinical studies, while creating and maintaining statistical programming documentation including programming specifications as appropriate and in alignment with industry and regulatory standards.

This role will also support database programming activities providing data listings, TFLs, and other results for medical data review and monitoring, metrics generation, etc.

Responsibilities

• Aggressively seek out needed specification details for the deliverables.
• Perform quality control of datasets (ADaM, SDTM, SEND) based on CDISC dataset specifications, standard and custom data tables, listings, and graphs, as well as derived datasets and specifications.
• Ensure the quality of tables, figures, and listings (TFLs) on time for electronic submission to regulatory agencies.
• Develop SAS validation procedures and test plans, as necessary.

Qualifications

• Minimum 5 to 10 years of industry experience (pharmaceuticals, biotechnology, or CRO) in developing or overseeing efficient development of submission ready programming code for clinical trials using the SAS-based Statistical Computing Environment.
• Strong CRO oversight experience
• Solid verbal and written communication skills.
• Demonstrated ability to speak up appropriately and ask necessary questions.
• Experienced hands-on skill in programming with SAS is required. Knowledge of additional programming languages is a plus.
• Good knowledge of statistics and oncology drug development process.
• Strong experience performing quality control of datasets (ADaM, SDTM, SEND) based on CDISC dataset specifications, standard and custom data tables, listings, and graphs, as well as derived datasets, associated metadata, and specifications.