7+ years of SAS programming experience in phase I-IV clinical trials
Proficient in SAS-Base, MACRO, STAT, GRAPH, ACCESS, and MS Office
Familiarity with CDISC data standards such as SDTM and ADaM
Experience with Unix and Windows operating systems
Understanding of software development life cycle and FDA guidelines
Strong organizational, time management, and attention to detail skills
Responsibilities
Support Biostatistics team by overseeing programming and validation activities for clinical studies
Contribute to the efficiency and best practices of the Biostatistics group
Provide programming and validation support for clinical study reports and publications
Access and convert data to SAS from various formats
Collaborate with external vendors to develop and monitor SAS datasets
Work with clinicians and statistician to QC publication outputs
Provide input for Database and CRF Development, creating edit check programs
Benefits
Collaborative team environment
Opportunity to improve and innovate programming processes
Involvement in high-impact clinical research activities
Support for professional development and learning
Exposure to advanced statistical methodologies
Working with experienced professionals in the field
Full Job Description
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
reas: SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests (e.g.,publications)
ccessing 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
pplies good judgment and demonstrates initiative to resolve issues
Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment
