Katalyst CRO
Position Overview
As a senior SAS programmer, you will support the Biostatistics team by carrying out programming activities, overseeing external vendors, and ensuring timely and accurate programming, validation, and reporting for clinical studies and publications.
Responsibilities
Support Biostatistics team with programming activities and oversee external vendors as needed.
Provide statistical programming and validation support for clinical study reports, SDTM/ADaM datasets, tables, figures, listings, and publication requests.
Convert data to SAS from database management systems and PC file formats (e.g., Excel, text).
Work with external vendors to develop or monitor SAS dataset content and structure.
Collaborate with clinicians, statisticians, and publication managers to generate and QC outputs for publications, reviewing abstracts and manuscripts for accuracy and soundness of statistical methodologies.
Provide input to database and CRF development, creating edit check programs and giving feedback to Data Management.
Contribute to the development of statistical analysis plans, dataset specifications, validation plans, and related documents.
Maintain standards for programming activities.
Work independently to accomplish tasks and goals defined by the supervisor.
Bring in new ideas to improve the programming process.
Requirements
Minimum bachelor’s degree in a related science discipline.
7+ years of experience in SAS programming for Phase I‑IV clinical trials in a pharmaceutical/CRO environment.
Experience using SAS Base, Macro, Stat, Graph, Access, MS Office.
Experience with CDISC data standards, e.g., SDTM and ADaM.
Proven experience with Unix and Windows operating systems.
Understanding of the software development life cycle.
Understanding of FDA guidelines.
Good organization, time‑management, and attention‑to‑detail skills to work in a stressful environment under tight deadlines.
Good judgment and initiative to resolve issues.
Strong verbal, written, and interpersonal communication skills.
Seniority level Mid‑Senior level
Employment type Contract
Job function Information Technology
Industries Pharmaceutical Manufacturing
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Responsibilities
Support Biostatistics team with programming activities and oversee external vendors as needed.
Provide statistical programming and validation support for clinical study reports, SDTM/ADaM datasets, tables, figures, listings, and publication requests.
Convert data to SAS from database management systems and PC file formats (e.g., Excel, text).
Work with external vendors to develop or monitor SAS dataset content and structure.
Collaborate with clinicians, statisticians, and publication managers to generate and QC outputs for publications, reviewing abstracts and manuscripts for accuracy and soundness of statistical methodologies.
Provide input to database and CRF development, creating edit check programs and giving feedback to Data Management.
Contribute to the development of statistical analysis plans, dataset specifications, validation plans, and related documents.
Maintain standards for programming activities.
Work independently to accomplish tasks and goals defined by the supervisor.
Bring in new ideas to improve the programming process.
Requirements
Minimum bachelor’s degree in a related science discipline.
7+ years of experience in SAS programming for Phase I‑IV clinical trials in a pharmaceutical/CRO environment.
Experience using SAS Base, Macro, Stat, Graph, Access, MS Office.
Experience with CDISC data standards, e.g., SDTM and ADaM.
Proven experience with Unix and Windows operating systems.
Understanding of the software development life cycle.
Understanding of FDA guidelines.
Good organization, time‑management, and attention‑to‑detail skills to work in a stressful environment under tight deadlines.
Good judgment and initiative to resolve issues.
Strong verbal, written, and interpersonal communication skills.
Seniority level Mid‑Senior level
Employment type Contract
Job function Information Technology
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr