Statistical Programmer

June 29

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MCRA

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Leading Global Full-Service Medical Device, Diagnostics & Biologics CRO & Integrated Consulting Advisory Firm.

Clinical Affairs • Quality Assurance • Regulatory Affairs • Reimbursement • Healthcare Compliance

51 - 200

Description

• Process Electronic Data Capture (EDC) data into analytical datasets • Create Tables, Listings, and Figures to support Regulatory Clinical Trials • Develop and maintain SAS programs for data importing, quality assurance, and reporting • Produce Define XML/PDFs, aCRFs, and Reviewers Guides to support SDTMs and ADaMs • Create listing and safety outputs (analysis datasets, tables, figures) to a high standard of quality and accuracy • Create, document and validate macros at the table, listing and figure level • Maintain PDVD according to the procedures for Planning, Executing, Tracking and Documentation of Programming and Validation activities • Trouble-shoot and resolve programming issues in a timely and efficient manner • Perform various tasks per project specific timelines under supervision • Interface with client/sponsor organizations in team meetings • Collaborate with other departments within MCRA • Technical writing and review of documents and deliverables • Represent MCRA at conferences and meetings as needed • Complete other duties and projects as assigned • Ensure all work products comply with SOPs, regulations, standards, policies, and the mission of MCRA

Requirements

• Bachelor's degree in Mathematics, Statistics, Biostatistics, Epidemiology, or related scientific field • 3+ years of experience with statistical programming in the CRO, medical device, or pharmaceutical industry is required • SAS certified preferred • Experience and familiarity with medical devices is highly preferred • Must have expertise of R programming as well as SAS® Base, and good knowledge of SAS® graph and SAS® Macros • Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician • Strong knowledge of data standards for clinical research and statistical analysis including CDISC SDTM, ADaM, and ICH Statistical Principles for Clinical Trials • Thorough understanding of relational database components and theory • Excellent application development skills • Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results • Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes • An understanding of quality control as it relates to regulatory documentation requirements is preferred • Experience with adaptive trials and Bayesian analysis techniques is desired • Ability to read, analyze, and interpret complex documents • Strong research, analytical, critical-thinking, and problem-solving skills • Must be able to manage multiple projects and deliverables simultaneously and generate meaningful results • PC/Technical skills: strongly proficient in MS Office Suite, Excel, Word, PowerPoint • Excellent oral and written communication skills and presentation skills

Benefits

• Less than 10% travel required