Senior Biostatistician
$70 - $85 per hourCollabera
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Seeking an experienced Biostatistician III to support clinical development programs by analyzing ongoing clinical trial data and providing data-driven insights to study teams. This role will partner with statisticians, programmers, and cross-functional stakeholders to monitor study progress, evaluate predefined criteria, conduct exploratory analyses, and support informed decision-making throughout the clinical trial lifecycle. Key Responsibilities:
- Review and analyze accumulating clinical trial data to evaluate study progress and performance metrics.
- Conduct exploratory, interim, and monitoring analyses to identify trends, risks, and opportunities.
- Partner with study statisticians, programmers, and cross-functional teams to support trial oversight activities.
- Develop and execute statistical analysis plans for clinical research studies.
- Provide timely statistical insights and recommendations to support study execution and decision-making.
- Support statistical planning and analysis activities across clinical development programs.
- Coordinate with internal and external programming teams to ensure accurate and efficient data analyses.
- Maintain compliance with applicable regulatory and scientific standards throughout study execution.
- Communicate analytical findings through reports, presentations, and technical documentation. Required Qualifications:
- Master's degree or Doctorate in Statistics , Biostatistics , Data Science , Mathematics , Epidemiology , or a related quantitative discipline.
- Minimum 5 years of experience in the pharmaceutical, biotechnology, or clinical research industry.
- Strong knowledge of statistical methodologies and clinical trial data analysis.
- Experience with statistical programming using R .
- Experience preparing analysis programs for Phase I, Phase II, and Phase III clinical trials.
- Strong understanding of clinical trial design and statistical applications within clinical research.
- Ability to analyze complex datasets and translate findings into actionable business and scientific insights.
- Excellent written, verbal, and technical communication skills.
- Experience conducting data monitoring, interim analyses, and exploratory analyses. Preferred Qualifications:
- Doctorate in a quantitative discipline.
- Experience using SAS for clinical data analysis.
- Experience serving as a lead or primary statistician for regulatory submissions.
- Knowledge of drug development regulations and statistical requirements supporting clinical research programs.
- Experience supporting New Drug Application or Biologics License Application submissions.
- Biostatistics
- Clinical Trials
- R Programming
- Statistical Analysis
- SAS
- Data Monitoring
- Exploratory Analysis
- Interim Analysis
- Clinical Research
- Study Design
- Regulatory Submissions
- Data Science
- Recruiter
- Phone
- Gagandeep Singh
- View email address on click.appcast.io
- View phone number on click.appcast.io
Vacancy posted 4 days ago
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