Company Overview
The Cardiovascular Research Foundation® (CRF®) is a world-renowned leader in interventional cardiovascular medicine. Committed to advancing the field, CRF® drives medical innovation, conducts pioneering research, and delivers transformative education. Through its dedication to excellence, CRF® empowers healthcare professionals with the knowledge and tools needed to improve patient outcomes, increase survival rates, and enhance the quality of life for millions across the globe.
Summary
As a key member of clinical trial teams, the Senior Biostatistician provides expert statistical support throughout all phases of clinical research, including pre-clinical, Phase I-IV, and post-marketing studies. Collaborating within cross-functional teams, the Senior Biostatistician ensures the timely delivery and scientific rigor of study results. This role involves close coordination with statistical colleagues and company programmers to guarantee accurate, seamless, and prompt reporting of scientific data for company-sponsored or conducted clinical trials.
The Senior Biostatistician also partners with physicians and principal investigators on academic and sponsor-led quantitative analyses. Responsibilities include developing statistical analysis plans, designing table shells, contributing to research manuscripts, and participating in clinical safety boards. The position requires advanced statistical expertise, creative problem-solving, and strong theoretical knowledge.
Key Responsibilities
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Design, analyze, and report on new and ongoing sponsor-related clinical trials.
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Review and develop statistical sections for study protocols and perform sample size calculations.
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Prepare detailed statistical analysis plans along with table, listing, and graph shells.
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Collaborate with SAS programmers, data managers, and physicians to review case report forms, identify data quality issues, and generate analysis datasets and outputs.
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Validate statistical analyses to ensure accuracy in final clinical study reports and provide meaningful interpretation of results.
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Work closely with project management, team members, and investigators to ensure timely and precise clinical data reporting.
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Coordinate with medical directors and writers to ensure the validity of data interpretations and draft relevant sections of clinical trial and statistical reports.
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Utilize SAS programming extensively; knowledge of additional programming languages is desirable.
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Collaborate with cardiovascular physicians on academic research projects.
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Participate in Data Safety Monitoring Boards.
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Represent the Biostatistics group in meetings with regulatory agencies and project teams.
Qualifications
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PhD in Biostatistics or Statistics, with clinical trial experience preferred.
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Background in cardiology or medical device clinical trials is advantageous.
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Proficiency in SAS programming.
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Experience authoring manuscripts, clinical documents, and templates.
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Ability to formulate research hypotheses and apply rigorous analytical methods.
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Comprehensive understanding of clinical trial processes and the statistician’s role.
Benefits
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Comprehensive health plans including medical, dental, and vision coverage.
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Company-paid short-term and long-term disability, plus life insurance.
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Flexible spending accounts for health and dependent care.
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Pre-tax travel expense benefits via the TransitChek program.
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401(k) retirement savings plan.
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Generous paid time off (PTO) and ten paid holidays annually.
Compensation
The salary range for this role is $105,000 to $115,000 per year. The final offer will be based on the candidate’s relevant knowledge, education, skills, and experience.