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Biostatistics Consultant

Compass Consulting

Miami, FL

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JOB DETAILS
SKILLS
Bayesian Networks, Biostatistics, Biotech and Pharmaceutical, Clinical Data Interchange Standards Consortium (CDISC), Clinical Trial, Communication Skills, Consulting, Contract Research Organization (CRO), Cross-Functional, Drug Development, FDA (Food and Drug Administration), GCP (Good Clinical Practices), Healthcare, ICH Regulations, Leadership, R Programming Language, Regulations, Regulatory Compliance, Regulatory Submissions, Standard Operating Procedures (SOP), Team Lead/Manager, Time Management, Willing to Travel
LOCATION
Miami, FL
POSTED
30+ days ago

Are you a seasoned biostatistics expert with a passion for advancing healthcare through cutting-edge scientific leadership? Our client is seeking a highly skilled Director of Biostatistics to spearhead our clinical development programs. In this pivotal role, you will shape the future of our clinical studies, ensuring the highest standards of scientific excellence, regulatory compliance, and innovation. Lead a dynamic team and collaborate across functions to bring transformative therapies to patients worldwide.


What You’ll Bring to the Table:
  • Master’s or PhD in Biostatistics or a related field
  • Minimum of 10 years’ experience in the pharmaceutical, biotechnology, or CRO industry
  • Proven expertise in biostatistical methodologies, including survival analysis, Bayesian methods, missing data, and adaptive designs
  • Proficiency in SAS and/or R; familiarity with CDISC standards (SDTM, ADaM)
  • Strong understanding of FDA, EMA, and ICH regulations, and experience with regulatory submissions
  • Excellent communication skills and the ability to work seamlessly within cross-functional teams
  • Ability to work independently with minimal supervision
  • Willingness and ability to travel up to 5%


Additional Skills That Set You Apart:
  • Deep experience in applying advanced statistical techniques in clinical contexts
  • Experience managing CROs and external vendors to ensure high-quality, timely deliverables
  • Familiarity with regulatory authority interactions and submissions
  • Background in developing departmental SOPs aligned with ICH, GCP, and CDISC standards

About the Company

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Compass Consulting