Katalyst CRO
Sr. SAS Programmer
role at
Katalyst CRO
Responsibilities
To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies and publications.
Contributes to the overall efficiency and best practice of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.
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 the study programmers to achieve timely progress.
Areas include: SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests (e.g., publications).
Access data 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 data sets.
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 the development of 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' 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 in CDISC data standards, e.g., SDTM and ADaM.
Proven experience with Unix and Windows operating systems.
Understanding of the software development life cycle and FDA guidelines.
Good organization, time management and attention to detail skills; ability to work under tight deadlines while maintaining quality.
Strong judgment, initiative, and problem-solving abilities.
Strong verbal and written communication skills; ability to work effectively in a team environment.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Information Technology
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
role at
Katalyst CRO
Responsibilities
To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies and publications.
Contributes to the overall efficiency and best practice of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.
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 the study programmers to achieve timely progress.
Areas include: SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests (e.g., publications).
Access data 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 data sets.
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 the development of 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' 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 in CDISC data standards, e.g., SDTM and ADaM.
Proven experience with Unix and Windows operating systems.
Understanding of the software development life cycle and FDA guidelines.
Good organization, time management and attention to detail skills; ability to work under tight deadlines while maintaining quality.
Strong judgment, initiative, and problem-solving abilities.
Strong verbal and written communication skills; ability to work effectively in a team environment.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Information Technology
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr