Sr. SAS Programmer

Katalyst CRO; Worcester (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO in Worcester, MA seeks an experienced SAS Programmer to support the Biostatistics team by performing programming activities and overseeing external vendors to ensure timely and accurate programming and validation for clinical studies and publications.

You will collaborate with clinicians, statisticians, and publication managers, contribute to SDTM/ADaM data handling, create analysis outputs, and help develop statistical analysis plans while maintaining programming standards and

Qualifications

• Bachelor's degree in a related science discipline.
• 7+ years SAS programming for phase I–IV clinical trials in pharma/CRO.
• Proficient in SAS Base, Macro, STAT, GRAPH and ACCESS.
• Experience with CDISC SDTM/ADaM and FDA guidelines.
• Strong organization, time management and attention to detail.

Responsibilities

• Support Biostatistics by programming and overseeing external vendors as needed.
• Ensure timely, accurate programming and validation for studies and publications.
• Coordinate activities among study programmers to progress SDTM/ADaM outputs.
• Create/edit check programs and contribute to analysis plans.
• Review publications for methodological soundness and QC outputs.
• Maintain programming standards and work independently per supervisor.

Skills

SAS programming

SAS Macro

CDISC SDTM/ADaM

Clinical trial experience

Unix/Windows

Education

Bachelor's degree in related science

Tools

SAS Base

SAS Macro

SAS STAT

SAS GRAPH

SAS ACCESS

MS Office

Unix

Windows OS

CDISC standards

Job description

• 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
• Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following
• areas: SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests (e.g.,publications)
• Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files)
• Working with external vendors in order to develop or monitor the content and structure of SAS data sets
• Working closely with clinicians, statistician, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review
• Providing input to the Database and CRF Development, creating edit check programs and providing feedback to the Data Management
• Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents
• Maintaining standards for programming activities
• Working independently to accomplish tasks and goals defined by supervisor
• Bringing in new ideas to improve the programming process

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
• Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following
• areas: SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests (e.g.,publications)
• Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files)
• Working with external vendors in order to develop or monitor the content and structure of SAS data sets
• Working closely with clinicians, statistician, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review
• Providing input to the Database and CRF Development, creating edit check programs and providing feedback to the Data Management
• Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents
• Maintaining standards for programming activities
• Working independently to accomplish tasks and goals defined by supervisor
• Bringing in new ideas to improve the programming process

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
• Understanding of FDA guidelines
• Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality
• Applies good judgment and demonstrates initiative to resolve issues
• Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment