Contractor Biostatistician

Biostatistician Role at RQM+

Collaborate with medical writers and subject matter experts to support regulatory submissions for medical devices. Lead statistical design for post-market clinical activities and analysis.

Responsibilities:

• Understand study materials (CERs, study plans, questioners).
• Check and clean data (raw, summary, summary+ excel).
• Perform data validation checks.
• Produce tables and figures for planned objectives.
• Generate statistical reports and presentations for client delivery.
• Provide statistical guidance for clinical studies (pre-market & post-market).
• Develop Statistical Analysis Plans, and sample size calculations.
• Provide materials and guidance to other team members for clinical data collection.
• Develop evidence generation strategy.
• Develop Post-Market Activity Presentation Materials.
• Provide initial interpretations of results.
• Address regulatory authority questions related to statistical design & analysis.
• Conduct data analysis to support clinical study reports, evaluation reports, publications.
• Represent Biostatistics function in cross-functional teams.
• Collaborate for development of Clinical Investigational Plans, Clinical Study Reports.
• Work with Data Management to define edit specifications and critical variable lists, support data cleaning.
• Manage database lock & unblinding processes.
• Build relationships with study investigators to identify publication needs.
• Provide statistical support throughout the publication process.
• Stay updated on industry and academic developments.
• Manage resources and budget for statistical analysis.
• Provide leadership and guidance to team members.

Requirements:

• Advanced degree in Biostatistics or Statistics (Master's or Ph.D).
• 2-8 years of clinical research biostats experience.
• Experience in the development of Statistical Analysis Plans for regulatory submissions.
• Strong capability to interact with internal & external teams.
• Proven track record in designing clinical studies.
• Experience in adaptive design.
• In-depth knowledge and experience in statistical analysis and clinical study reports.
• Proficient in R and/or SAS programming.
• Bridge analytics to clinical interpretation.
• Analysis of large datasets.
• Knowledge of 21 CFR part 812, GCP, ISO14155.
• Excellent communication, presentation, teamwork skills.
• Attention to detail and scientific integrity.
• Strong organizational, planning, project management skills.

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