Senior Statistical Programmer

3 weeks ago


Long Beach, United States Katalyst Healthcares and Life Sciences Full time

Responsibilities:

Program and validate datasets and SDTMs, including complex efficacy, labs, etc. Program complex non efficacy outputs/figures Perform Senior Review and Deliver QC of non- statistical output Develop and debug complex macros Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc. Knowledge, interpretation and implementation of current SDTM, ADAM standards Knowledge of FDA CRT requirements including define.xml and define.pdf Become familiar with and follow study documentation Lead a team for furthering programming development Responsible for study level resources ttend and input to company resourcing meeting Point of contact for programming issues for the team, proactively ensuring everything is working cohesively Develop and deliver company-wide training as and when required Experience of programming to SDTM and ADaM standards (CDISC)

Requirements: BSc or above in Computer Science, Mathematics or a Science related discipline SAS Programming experience within a clinical trials environment (CRO, pharma or academia) Good awareness of clinical trial issues, design, and implementation Familiarity with GCP and regulatory requirements Excellent written and verbal communication skills

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