Responsibilities: Data preparation and cleaning. Cleaning and transforming raw clinical trial data from various sources to ensure accuracy and consistency for PK/PD analysis. Programming PK/PD analyses. Writing SAS code to perform descriptive analysis of PK/PD data and statistical analysis of exposure-response relationships. Data visualization. Creating clear and informative graphs and tables to effectively communicate PK/PD findings. CDISC compliance. Ensuring data is formatted according to CDISC standards for regulatory submissions. Validation and quality control. Performing thorough validation checks on programming code and analysis results to maintain data integrity. Identifies problems and develops tools that increase the efficiency and capacity of the Clinical PK/PD Programming group. Provide trainings to fellow programmers on industrial guidances, new or enhanced features of software tools that are relevant or applicable to job function above. Requirements: Bachelor's degree in Stats, Computer Science or any life sciences degree. 7+ years of industrial experience. Must have advanced SAS programming skills, with knowledge of other statistical software like R being beneficial. Knowledge of CDISC standards (SEND, SDTM, and ADaM) is required. Experience visualizing/presenting data for internal stakeholders or clients. Capable of implementing more advanced modeling and statistical procedures as requested by study team. Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis, and reporting/modeling of analysis results. Including handling of data issues and uncleaned data. Professional attitude, self-motivated, logical thinking. Excellent attention to detail. Strong organization skills and ability to work on multiple tasks simultaneously while achieving quality standards and meeting deadlines. Good verbal and written communication skills. Strong interpersonal skills and ability to work collaboratively across teams. Ability to problem solve and develop innovative approaches along with a drive to learn and master new techniques and technologies. Katalyst Healthcares and Life Sciences
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