Katalyst CRO
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Clinical Application Specialist III
role at
Katalyst CRO .
Responsibilities
In-depth knowledge of CDISC Standards, SAS programming concepts, and techniques appropriate to the pharmaceutical industry.
Experience leading compound-level data integration efforts to create pooled ADAM datasets from multiple studies across indications.
Experience in ADaM specification and SAS programs development supporting ISS/Client ADaM programming and submissions.
Oversee and be responsible for the creation and validation of SDTM, ADaM and TLFs for CSR, ISS, and Client following Client's SOPs, department, and project standards.
Support IB, DSUR, and Annual Safety Reporting deliverables.
Ability to quickly learn internal macros, processes, and programming environment.
Team player with excellent communication skills, engaging with statisticians, data management personnel, and Pharmacovigilance stakeholders.
Ensure accurate derivations as defined in the protocol and statistical analysis plan.
Ensure internal consistency of output and assess consistency with other activities for the project (Pooled data vs. ISS, Study data).
Interpret statistical analysis plans to develop analysis data set specifications.
Implement all Client's process improvements.
Provide accurate and timely responses to client requests with urgency.
Maintain compliance with training requirements.
Requirements
BS or MS in Statistics, Computer Science, or related field with at least 8 years of SAS programming experience in the pharmaceutical or related industry.
Extensive experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA.
Excellent working experience in SDTM and ADaM datasets creation and validation.
High degree of technical competence and excellent oral and written communication skills.
Hands‑on experience in SAS programming, macro, and utilities development.
Des Plaines, IL $92,412 - $115,032
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Clinical Application Specialist III
role at
Katalyst CRO .
Responsibilities
In-depth knowledge of CDISC Standards, SAS programming concepts, and techniques appropriate to the pharmaceutical industry.
Experience leading compound-level data integration efforts to create pooled ADAM datasets from multiple studies across indications.
Experience in ADaM specification and SAS programs development supporting ISS/Client ADaM programming and submissions.
Oversee and be responsible for the creation and validation of SDTM, ADaM and TLFs for CSR, ISS, and Client following Client's SOPs, department, and project standards.
Support IB, DSUR, and Annual Safety Reporting deliverables.
Ability to quickly learn internal macros, processes, and programming environment.
Team player with excellent communication skills, engaging with statisticians, data management personnel, and Pharmacovigilance stakeholders.
Ensure accurate derivations as defined in the protocol and statistical analysis plan.
Ensure internal consistency of output and assess consistency with other activities for the project (Pooled data vs. ISS, Study data).
Interpret statistical analysis plans to develop analysis data set specifications.
Implement all Client's process improvements.
Provide accurate and timely responses to client requests with urgency.
Maintain compliance with training requirements.
Requirements
BS or MS in Statistics, Computer Science, or related field with at least 8 years of SAS programming experience in the pharmaceutical or related industry.
Extensive experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA.
Excellent working experience in SDTM and ADaM datasets creation and validation.
High degree of technical competence and excellent oral and written communication skills.
Hands‑on experience in SAS programming, macro, and utilities development.
Des Plaines, IL $92,412 - $115,032
#J-18808-Ljbffr