Job Details. Responsibilities. The Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials. This role is key to implementing programming standards and supporting the standardization of CDISC-compliant datasets (e.g., SDTM, ADaM) across clinical programs. Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures...
Job Details. Responsibilities. Engage directly with cross-functional teams and contribute to high-visibility clinical initiatives. Work on-site in a collaborative setting that encourages knowledge sharing and technical excellence. Lead programming efforts supporting clinical studies and regulatory deliverables. Develop and validate SDTM and ADaM datasets in alignment with CDISC standards. Produce high-quality analysis outputs, including tables, l...
Job Details. Responsibilities. Review protocols for CDISC conformance. Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements. Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with Emmes' SDTM Implementation Guide, project standards, and the study protocol. Create DEFINE specifications for mapping of SDTM and ADaM compliant datasets. Review and QC submission ready SDTM datasets, ...
Responsibilities. Review protocols for CDISC conformance. Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements. Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with Emmes' SDTM Implementation Guide, project standards, and the study protocol. Create DEFINE specifications for mapping of SDTM and ADaM compliant datasets. Review and QC submission ready SDTM datasets, define.xml, a...
Responsibilities. Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development ...
Responsibilities. Conduct statistical programming and analysis of clinical research studies. Provide programming support for publication efforts and regulatory submissions. Manage the timely creation, review, completion, and delivery of statistical programming activities and deliverables for study projects. Perform acquisition and curation of data, including full Clinical Data Interchange Standards Consortium (CDISC) standardization and Pseudo-CD...
Responsibilities. Demonstrating proficiency in CDISC, SDTM, and ADaM to support various submission activities, including IA, CSR, DSUR, and publications. Providing statistical programming support to generate tables, listings, and figures for assigned projects. Overseeing all aspects of statistical programming, working closely with statisticians to ensure timely and accurate delivery of statistical outputs. Creating detailed specifications for ind...
Responsibilities. Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development ...
Responsibilities. Review protocols for CDISC conformance. Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements. Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with Emmes' SDTM Implementation Guide, project standards, and the study protocol. Create DEFINE specifications for mapping of SDTM and ADaM compliant datasets. Review and QC submission ready SDTM datasets, define.xml, a...
Job Details. Responsibilities. Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget. Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences. Ensure all relevant deliverables including inv...
