Katalyst CRO
Overview
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Statistical Programmer
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Katalyst CRO Responsibilities
Demonstrated practical understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry. Demonstrated satisfactory ability to apply SAS programming knowledge and work independently to solve problems related to non-routine situations. Responsible for the creation and validation of SDTM, ADaM and TLFs for CSR, ISS, and Client following SOPs, department, and project standards. Ensure internal consistency of output and assess consistency with other activities for the project (e.g., ISS, Client), as applicable. Responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and resolving Pinnacle21 checks. Responsible for the creation and accuracy of derivations as defined in the protocol and statistical analysis plan. Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications. Ensure consistency across studies within a project. Responsible for the creation of data definition documents, TOCs, and support submission related activities. Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers. Develop new macros and utilities. Provide accurate and timely responses to requests from clients with a sense of urgency. Be compliant with training requirements. Qualifications/Requirements
MS in Statistics, Computer Science, or a related field with 3+ years of SAS programming experience in Pharmaceutical or related industry OR BS in a related field with 5+ years of SAS programming experience in Pharmaceutical or related industry. E-sub experiences (CDISC dataset, creating define file, etc.). Strong experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. Strong working experience/skill in SDTM and ADaM datasets creation/validation. Strong technical and communication skills, both oral and written. Competent in SAS programming, macro, and utilities development. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Biotechnology IT Services and IT Consulting
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Join to apply for the
Statistical Programmer
role at
Katalyst CRO Responsibilities
Demonstrated practical understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry. Demonstrated satisfactory ability to apply SAS programming knowledge and work independently to solve problems related to non-routine situations. Responsible for the creation and validation of SDTM, ADaM and TLFs for CSR, ISS, and Client following SOPs, department, and project standards. Ensure internal consistency of output and assess consistency with other activities for the project (e.g., ISS, Client), as applicable. Responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and resolving Pinnacle21 checks. Responsible for the creation and accuracy of derivations as defined in the protocol and statistical analysis plan. Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications. Ensure consistency across studies within a project. Responsible for the creation of data definition documents, TOCs, and support submission related activities. Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers. Develop new macros and utilities. Provide accurate and timely responses to requests from clients with a sense of urgency. Be compliant with training requirements. Qualifications/Requirements
MS in Statistics, Computer Science, or a related field with 3+ years of SAS programming experience in Pharmaceutical or related industry OR BS in a related field with 5+ years of SAS programming experience in Pharmaceutical or related industry. E-sub experiences (CDISC dataset, creating define file, etc.). Strong experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. Strong working experience/skill in SDTM and ADaM datasets creation/validation. Strong technical and communication skills, both oral and written. Competent in SAS programming, macro, and utilities development. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Biotechnology IT Services and IT Consulting
#J-18808-Ljbffr