77 applicants

Company

Original Job Post

MCRA · 4 days ago

Statistical Programmer

United States

Full-time

Remote

Mid Level

3+ years exp

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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.

Establish and maintain effective working relationships with clients and MCRA project team members (internal and external), including Data Management personnel, Statistical Programmers, Clinical Research personnel, and Regulatory Affairs personnel.

Participate in presentations at client and investigator meetings.

Assist in business development functions to secure new clients and projects.

Interface with client/sponsor organizations as a representative of the biostatistical and statistical programming team.

Work collaboratively with other MCRA departments 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.

Ensure all work products comply fully with SOPs, regulations, standards, policies, and the mission of MCRA.

Qualification

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Statistical programmingMedical devicesSASR programmingSAS BaseSAS MacrosAdvanced statistical proceduresData standardsCDISC SDTMADaMICH Statistical PrinciplesRelational databaseApplication developmentClinical trial dataData manipulationICH guidelinesProject managementMS OfficeExcelWordPowerPointProblem-solvingAnalyticalCritical-thinkingCommunicationPresentationTime-managementAdaptive TrialsBayesian AnalysisQuality Control

Required

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.

Experience and familiarity with medical devices is highly preferred.

SAS certified 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

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