Job Summary (Primary function)
The Sr. Principal PK/PD SAS Programmer processes PK/PD data required for Phase I — III clinical trials, develops SAS macros to facilitate data management and analyses, and performs exposure-Qtc analysis and exploratory statistical analyses on PK/PD relationship.
Essential Functions of the Job (Key responsibilities)
·Work independently to ensure the accuracy and quality of delivered results to satisfy the requirement of healthy authorities.
·Develop standard SAS macros for efficient analyses of clinical data which will be validated and can be production use.
·Interact with members of the multidisciplinary team to establish project timelines; computerized data validation checks and ad hoc requests.
·Design and implement statistical algorithms and code in conformance with defined programming processes and standard operating procedures.
·Ensure that all programs, outputs and documentation are consistent with relevance.
·Generate PK/PD analysis data sets and provide summary tables, graphs and data listings using SAS to support NCA or pop PK/PD analysis.
·Write statistical analysis plan and perform exposure-analysis on Qtc as requested.
·Work with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure timelines and deliverables are met.
·Assess data accuracy and consistency.
Qualifications (Minimal acceptable level of education, work experience, and competency)
·BA/BS degree.
·Minimum 10 years of programming experience using SAS/Base/Macro/GRAPH in the biopharmaceutical and/or CRO industries.
·Data Management experience is highly desirable.
·SAS programming skills and attention to detail are essential.
·Demonstrated knowledge of regulatory biostatistics, SOPs, and guidelines.
·Highly motivated and able to work well independently
·May lead other jr. programmers
·Strong organizational, time management and project coordination skills.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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