Job Description

• 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.

• 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.

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