Senior Statistical Programmer at Katalyst HealthCares & Life Sciences

Responsibilities:

• Programs SAS Non-System Edit Checks, Protocol Deviations and SAS Data Listings
• Ability to independently develop innovative and complex SAS programs to support activities including, but not limited to, data review and reporting, and development of patient profiles.
• Supports the maintenance of the Non-System Edit Check Global Library to ensure consistency across programs and studies and concordance with the EDC Global Library
• Create SAS program Specifications for Non-System Edit Checks based on CRF and non-CRF data.
• Responsible for participating in the development and review of data transfer specifications, processing of clinical data downloads, and data transfers to/from service providers.
• Create Clinical Data Review Tools [i.e., Data Listing Reports (DLRs); External Data Reconciliation Listings, Medical Safety Listings for reconciliation, etc.] for all studies based on study-specific specs and requirements.
• May oversee development of datasets (SDTMs/ADaMs) in CDISC-compliant format by CROs including clear documentation of the process that was followed in the form of specifications, trackers, and checklists.
• May be involved in QC of CRO deliverables like ADaMs, and tables, listings and figures.
• Independently develop SAS or other programs and specifications for the production of output to support study needs including publications, safety reporting, and ad hoc analyses in a timely fashion
• Independently verify other programmers' results
• Develop and/or validate standard macros to automate output production.
• Adhere to company SOPs and department guidelines.
• Work concurrently on multiple projects
• Troubleshoot technical and project issues.
• Help with infrastructure development of the department.
• Communicate effectively with internal cross-functional groups and external partners.

Requirements:

• BS/BA degree in related discipline
• At least 5 years of experience in statistical programming with clinical data and SAS
• Experience in oncology therapeutic area strongly preferred.
• Strong SAS programming skills required with proficiency in SAS/Base, SAS/Stat and SAS/Macros
• CDISC proficiency required.
• SAS/GRAPH experience desirable.
• Knowledge of appropriate regulations, industry standards and guidance documents
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.
• Good interpersonal communication skills to collaborate effectively with internal cross-functional groups and external partners.