Job Description

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases. Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs. Programs for quality checks for clinical study raw data and report the findings to Data Management. Provides input in the design and development of case report forms and clinical study databases. Reviews or author aCRF, SDTM and ADaM datasets specifications for datasets programming. Requirements: MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years. Experience in providing statistical programming support to early and late phase clinical trials. Excellent skills in SAS programming and statistical reporting. Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements. Familiarity with FDA and ICH regulations and guidelines. Excellent problem-solving skills. Good written and verbal communication skills and organizational and documentation skills. Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc. Ability to prioritize and multi-task effectively. Demonstrated positive attitude and the ability to work well with others.

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