Job Description

• 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.
• Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)
• Programs 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 eCRF, SDTM and ADaM datasets specifications for datasets programming
• Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s)
• Provides programming support for adhoc analysis.

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 4+ 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.

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