Statistical Programmer

Summary

Join MCRA, a leading medical device advisory firm and CRO, as a Statistical Programmer. You will be a key member of the Biostatistics team, responsible for creating and validating statistical programs, generating accurate outputs from clinical trial data, and collaborating with various teams. This role involves processing data, creating tables, listings, and figures, developing SAS programs, and ensuring compliance with standards. You will work on multiple projects simultaneously, collaborating with internal and external stakeholders. The ideal candidate is a self-starter with a passion for delivering high-value results and assisting device manufacturers.

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
• 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
• 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

Responsibilities

• 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
• Set- up standard programming directories and start-up utilities
• Participate in the review of in- progress audit findings and implement corrective actions, as required
• Establishes and maintains effective working relationships with clients and MCRA project team members (internal and external), including Data Management personnel, Statistical Programmers, and Clinical Research personnel
• Participates in presentations at client and investigator meetings
• Assist in business development functions (i.e., provide insight on BD calls, bid defenses, etc.) to secure new clients and projects and be a proactive advisor for all types of analysis from the proposal process through the project life cycle
• Interface with client/sponsor organizations as a representative of the biostatistical and statistical programming team in team meetings
• Work collaboratively with other MCRA departments, including clinical and regulatory to support their needs in terms of biostatistical resources
• 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 fully with SOPs, regulations, standards, policies, and the mission of MCRA

Preferred Qualifications

• Experience and familiarity with medical devices is highly preferred
• An understanding of quality control as it relates to regulatory documentation requirements is preferred
• Experience with adaptive trials and Bayesian analysis techniques is desired