Katalyst CRO
Join to apply for the
Sr. Statistical Programmer
role at
Katalyst CRO .
New York, NY $65,885.00-$98,827.00
Responsibilities
Conduct a comprehensive review of study documents, including Protocol, CRF, and SAP.
Create and assess statistical programs in SAS and/or R to produce CDISC-compliant SDTM and ADaM datasets.
Execute validation and quality control procedures for programs, datasets, and statistical reports, ensuring alignment with study requirements.
Develop and review CDISC SDTM and ADaM mapping specifications.
Produce and review Tables, Figures, and Listings (TFLs) in accordance with the statistical analysis plan.
Review datasets for any pending compliance issues and meticulously document identified issues.
Generate and review submission documents such as define.xml, SDTM annotated CRF, and reviewers guide.
Generate utility macros and efficient code to streamline programming processes.
Communicate effectively within project teams to ensure timely and budget‑compliant completion of assigned tasks.
Requirements
Master's degree or equivalent, along with relevant formal academic/vocational qualifications and a minimum of 4 years of SAS programming experience. Alternatively, a bachelor's degree with at least 6 years of SAS programming experience.
Minimum of 2 years of hands‑on CDISC implementation experience. Experience with R programming will be considered a significant plus.
Proficiency in SAS programming.
Previous involvement as a production or QC programmer at both product and study levels.
Strong organizational, interpersonal, leadership, and communication skills.
Ability to autonomously manage multiple tasks and projects.
In‑depth understanding of FDA regulatory guidance around Study Data and Submission, including familiarity with the Study Data Technical Conformance Guide, FDA Data Submission Standards Catalog, and associated requirements.
Strong understanding of CDISC Metadata Submission Guidelines (MSG), Define standards, CDASH, SDTM, ADaM, and controlled terminology standards.
Seniority Level Associate
Employment Type Contract
Job Function Information Technology
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr
Sr. Statistical Programmer
role at
Katalyst CRO .
New York, NY $65,885.00-$98,827.00
Responsibilities
Conduct a comprehensive review of study documents, including Protocol, CRF, and SAP.
Create and assess statistical programs in SAS and/or R to produce CDISC-compliant SDTM and ADaM datasets.
Execute validation and quality control procedures for programs, datasets, and statistical reports, ensuring alignment with study requirements.
Develop and review CDISC SDTM and ADaM mapping specifications.
Produce and review Tables, Figures, and Listings (TFLs) in accordance with the statistical analysis plan.
Review datasets for any pending compliance issues and meticulously document identified issues.
Generate and review submission documents such as define.xml, SDTM annotated CRF, and reviewers guide.
Generate utility macros and efficient code to streamline programming processes.
Communicate effectively within project teams to ensure timely and budget‑compliant completion of assigned tasks.
Requirements
Master's degree or equivalent, along with relevant formal academic/vocational qualifications and a minimum of 4 years of SAS programming experience. Alternatively, a bachelor's degree with at least 6 years of SAS programming experience.
Minimum of 2 years of hands‑on CDISC implementation experience. Experience with R programming will be considered a significant plus.
Proficiency in SAS programming.
Previous involvement as a production or QC programmer at both product and study levels.
Strong organizational, interpersonal, leadership, and communication skills.
Ability to autonomously manage multiple tasks and projects.
In‑depth understanding of FDA regulatory guidance around Study Data and Submission, including familiarity with the Study Data Technical Conformance Guide, FDA Data Submission Standards Catalog, and associated requirements.
Strong understanding of CDISC Metadata Submission Guidelines (MSG), Define standards, CDASH, SDTM, ADaM, and controlled terminology standards.
Seniority Level Associate
Employment Type Contract
Job Function Information Technology
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr