Katalyst CRO
Overview
Be among the first 25 applicants to support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors as needed, ensuring timely and accurate programming and validation activities for clinical studies and publications. Responsibilities
Provide statistical programming and validation support for clinical study reports, oversee programming activities by external vendors (e.g., CROs) when necessary, and coordinate programming activities among study programmers to achieve timely progress in areas such as SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests (e.g., publications). Access and convert data to SAS from database management systems and PC file formats (e.g., MS Excel, text files). Work with external vendors to develop or monitor the content and structure of SAS datasets. Collaborate with clinicians, statisticians, and publication managers to generate and QC outputs for publications; review publications (abstracts/manuscripts) to ensure accuracy, quality, and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activity metrics for management review. Provide input to database and CRF development, create edit check programs, and provide feedback to Data Management. Contribute to developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents. Maintain standards for programming activities and work independently to accomplish tasks and goals defined by supervisor; bring in new ideas to improve the programming process. Qualifications / Requirements
Minimum of bachelor’s degree in related science discipline. Minimum 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, and MS Office. Experience in CDISC data standards (SDTM and ADaM). Proven experience with Unix and Windows operating systems. Understanding of the software development life cycle and FDA guidelines. Strong organization, time management, and attention to detail; able to work under tight deadlines while maintaining quality. Good judgment, initiative to resolve issues, and strong verbal, written, and interpersonal communication skills for effective teamwork. Seniorities
Mid-Senior level Employment type
Contract Job function
Information Technology Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Be among the first 25 applicants to support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors as needed, ensuring timely and accurate programming and validation activities for clinical studies and publications. Responsibilities
Provide statistical programming and validation support for clinical study reports, oversee programming activities by external vendors (e.g., CROs) when necessary, and coordinate programming activities among study programmers to achieve timely progress in areas such as SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests (e.g., publications). Access and convert data to SAS from database management systems and PC file formats (e.g., MS Excel, text files). Work with external vendors to develop or monitor the content and structure of SAS datasets. Collaborate with clinicians, statisticians, and publication managers to generate and QC outputs for publications; review publications (abstracts/manuscripts) to ensure accuracy, quality, and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activity metrics for management review. Provide input to database and CRF development, create edit check programs, and provide feedback to Data Management. Contribute to developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents. Maintain standards for programming activities and work independently to accomplish tasks and goals defined by supervisor; bring in new ideas to improve the programming process. Qualifications / Requirements
Minimum of bachelor’s degree in related science discipline. Minimum 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, and MS Office. Experience in CDISC data standards (SDTM and ADaM). Proven experience with Unix and Windows operating systems. Understanding of the software development life cycle and FDA guidelines. Strong organization, time management, and attention to detail; able to work under tight deadlines while maintaining quality. Good judgment, initiative to resolve issues, and strong verbal, written, and interpersonal communication skills for effective teamwork. Seniorities
Mid-Senior level Employment type
Contract Job function
Information Technology Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr