Katalyst CRO
Responsibilities
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 study objectives 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 reports the findings to Data Management. 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. Provides programming support for adhoc analysis. Qualifications
MS in Statistics, Computer Science, or a related field with at least 3 years or a 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. Job details
Seniority level: Associate Employment type: Contract Job function: Information Technology Industries: Pharmaceutical Manufacturing
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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 study objectives 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 reports the findings to Data Management. 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. Provides programming support for adhoc analysis. Qualifications
MS in Statistics, Computer Science, or a related field with at least 3 years or a 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. Job details
Seniority level: Associate Employment type: Contract Job function: Information Technology Industries: Pharmaceutical Manufacturing
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