7+ years of SAS programming experience in clinical trials
Proficient in SAS-Base, MACRO, STAT, GRAPH, and MS Office
Familiarity with CDISC standards (SDTM and ADaM)
Experience with Unix and Windows operating systems
Knowledge of the software development life cycle and FDA guidelines
Strong organizational and time management skills
Responsibilities
Support the Biostatistics team with programming and vendor oversight
Enhance efficiency and best practices within the Biostatistics group
Provide programming support for clinical study reports and coordinate with external vendors
Access and convert data to SAS from various formats
Collaborate with external vendors to develop and monitor SAS data sets
Work with clinicians and publication managers to ensure statistical output quality
Contribute to Database and CRF development and create edit check programs
Benefits
Opportunities for professional development and training
Collaboration with a dynamic clinical team
Engagement with external partners and vendors
Emphasis on quality and best practices in programming
Innovative work environment fostering new ideas and improved processes
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 areas: 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.
