Associate Director - Statistical Programming

October 21

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Clinical Outcomes Solutions

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Patient Reported Outcomes • Health Economics and Outcomes Research • Clinical and Observational Research Design and Execution • Outcomes Regulatory Support • Statistics and Psychometrics

51 - 200

Description

• Working fully embedded within pharmaceutical clients. • Responsible for implementing reporting and analysis activities for clinical trials. • Provides expert technical support to team members. • Participates in overseeing CRO programmers to ensure consistency and quality.

Requirements

• At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred • 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies • Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment • Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation • Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities • Must be able to work independently • Outstanding communication skills (written and verbal) and strong leadership skills • Prior work experience with pharmacokinetic data and the neuroscience field, proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)