Katalyst Healthcares and Life Sciences
Principal Statistical Programmer
Katalyst Healthcares and Life Sciences, Boerne, Texas, United States, 78006
Responsibilities:
The Principal Statistical Programmer consultant will lead and support all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support ongoing clinical studies and requests for study report and regulatory submission. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks. Develop Tables, Figures, Listings (TFLs) deliverables from existing SAS programs for Clinical Study Report (CSR) if similar TFLs exist and from scratch for new outputs. Capacity for independent programming and review of reports and outputs. Customize outputs and graphics according to delivery specifications of target audience on the direction of biostatisticians. Responsible for supporting the Programming deliveries of a clinical study or project. Programs independently with high efficiency and quality. Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function. Ensures compliance with standards and automation usage. Plans and support team activities and tasks. Communicates and escalates risks within the assigned studies and/or projects. Requirements:
Bachelor's degree in computer science (CS), statistics, or related scientific disciplines with 8 yrs. of clinical programming (CDISC) experience; Master's degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience. Oncology/Hematology TA experience is required. ISS & Client experience is required. SAS and R programming is required. Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology. Good understanding of the clinical drug development process. Strong communication skills and coordination skills. Current knowledge of technical and regulatory requirements relevant for the role. Ability to proactively manage concurrent activities within a project.
The Principal Statistical Programmer consultant will lead and support all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support ongoing clinical studies and requests for study report and regulatory submission. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks. Develop Tables, Figures, Listings (TFLs) deliverables from existing SAS programs for Clinical Study Report (CSR) if similar TFLs exist and from scratch for new outputs. Capacity for independent programming and review of reports and outputs. Customize outputs and graphics according to delivery specifications of target audience on the direction of biostatisticians. Responsible for supporting the Programming deliveries of a clinical study or project. Programs independently with high efficiency and quality. Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function. Ensures compliance with standards and automation usage. Plans and support team activities and tasks. Communicates and escalates risks within the assigned studies and/or projects. Requirements:
Bachelor's degree in computer science (CS), statistics, or related scientific disciplines with 8 yrs. of clinical programming (CDISC) experience; Master's degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience. Oncology/Hematology TA experience is required. ISS & Client experience is required. SAS and R programming is required. Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology. Good understanding of the clinical drug development process. Strong communication skills and coordination skills. Current knowledge of technical and regulatory requirements relevant for the role. Ability to proactively manage concurrent activities within a project.