About the role
General Summary
Under general supervision of a Statistics Project Manager or higher, prepares analysis programs to support the preparation and statistical analysis of clinical data. Works closely with other programmers, biostatisticians, and clinical data managers with a leading role in the collection, analysis, and reporting of clinical data for trials.
Specific Duties and Responsibilities
•Following specifications, develops algorithms and writes programs to create datasets.* •Produces data listings, summary tables and graphs using analysis software.* •Independently checks data listings, summary tables and graphs.* •Imports and exports data.* •Assists data management group in performing data edit checks to facilitate data cleaning. •Maintains complete and in-depth understanding of all Clinical Data Interchange Standards Consortium (CDISC) guidance documents and implementation guides, as well as FDA guidance and regulations regarding electronic submission of data. Keeps abreast of industry trends in data mapping, data management, standards compliance methodologies, metadata management and data warehousing.* •Prepares clinical trial datasets and programs for regulatory submission. •Following statistical analysis plan, writes specifications for analysis datasets. •Interacts with the project statistician and other programmers participating on a project team. •Manage the data warehouse used to manage libraries of clinical study data. •Interact with regulatory affairs, quality assurance staff, and external clinical system vendors. •Mentors less experienced statistical programmers. •Act as the subject matter expert on CDISC and good statistical programming practices. •Builds efficient SAS coding and macro libraries. •Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements.* •Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.* •Ensure other members of the department follow the QMS, regulations, standards and procedures.* •Perform other work-related duties as assigned. *Indicates an essential function of the role
Position Qualifications
Minimum education and experience
•Bachelor's degree in Statistics, Computer Science or related field with 5+ years of statistical programming experience with 3+ years of experience in clinical statistical programming within medical device or related industry (biotechnology, pharmaceutical, Clinical Research Organization (CRO)) experience, or equivalent combination of education and experience