• *Must work onsite**
• Absolutely no VISAs/3rd party
• Develop SAS code according to specifications to create accurate, complete and efficient statistical analysis datasets (ADS) using raw data from multiple sources
• Develop programs to generate output tables, listings and graphs (TLG) according to the statistical analysis plan (SAP) in a timely fashion.
• Assist in the validation of derived datasets, programming specifications and tables, listings and graphs.
• Review data to verify integrity and consistency for completeness, accuracy, and suitability
• Create and maintain documentation for analysis dataset specifications and validation.
• Participate in the review of statistical analysis plans (SAP), CRFs, clinical study reports (CSR) and other documents essential to the conduct of statistical programming work for clinical trials.
• Conduct ad-hoc analyses
• Assist with developing tools and techniques for improving process efficiencies.
• Review and make recommendations for process development and improvement.
• Work collaboratively with Biostatisticians, other Statistical Programmers, Clinical Affairs and Safety to meet project deliverables and timelines for statistical data analysis and reporting
• **With a master’s 2-4 yrs experience is enough*
• A minimum of five (5) years of solid SAS programming experience with clinical data required.
• A bachelor’s degree, preferably in Mathematics, Statistics, Computer Science or related field required. A Master’s degree in Statistics is preferred and may be considered to offset minimum experience requirement.
• Knowledge of Windows operating systems required.
• Good oral and written communication skills are essential.
• Clinical trial and/or device experience in an industry setting is a plus.
• Programming experience in the pharmaceutical/medical device industry setting is a plus
• Knowledge of R is a plus
• Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department
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