Senior Statistical Programmer
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Dallas, TX 75217
Description:
Responsibilities:
- Programs SAS Non-System Edit Checks, Protocol Deviations and SAS Data Listings.
- bility 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.
- dhere 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.
- BS/BA degree in related discipline
- t 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.