Capricor Therapeutics, Inc. · 2 days ago
Director of Biostatistics
San Diego, CA
Full-time
Onsite
Director/Executive
$175K/yr - $220K/yr
7+ years expCapricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. The Director of Biostatistics will lead statistical strategy and execution across clinical development programs, ensuring robust study design, analysis, and interpretation to support regulatory submissions and business objectives.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Lead and coordinate statistical related activities to support clinical studies including but not limited to supporting the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence
Support is the statistical aspects of business-critical and/or regulatory commitments, provides input to program plans, and represent the Biostatistics function for cross-functional and intra-departmental teams or working groups
Functions as the lead statistician for assigned clinical projects
Performs management of in-house and/or outsourced biostatistical activities
May engage with regulatory authorities on compound/indication level discussions
Prepare or review the clinical study protocols, case report forms, statistical analysis plans, and table shells as needed
Create programs for data management activities, compliant analysis datasets, and statistical analysis of the clinical trial data
Prepare the statistical section of clinical trial reports and presentations of the results to the team
Demonstrate solid understanding of regulatory guidance and statistical methodology as applied to clinical studies in pharmaceutical development
Presenting interim trial data to Data Monitoring Committees (DMCs)
Writing statistical reports and memos with minimal guidance
Programming complex datasets
Leading or supporting complex analyses, including efficacy and futility interim analyses for DMCs
Supports the preparation and documentation of statistical analyses to enable management to write and support trial reports and publications
Helps ensure that new and revised statistical standards, tests, and processes are implemented for increased accuracy and efficiency
Reviewing statements of work, proposals, and budgets
Managing multiple projects and a majority of own workload
Perform such other duties as may be assigned from time to time
Qualification
Required
Master's Degree in statistics, biostatistics or a closely related field; PhD preferred
7+ years clinical trials experience
Strong knowledge of statistical software packages including SAS and other applications such as R, and SQL
Demonstrates strong leadership and management skills
Ability to write and articulate clearly
Strong sense of urgency and commitment to excellence in the successful achievement of defined project objectives
Ability to prioritize workload to meet multiple project timelines
Excellent planning and organization skills
Excellent problem-solving abilities
Ability to function independently and exercise judgment and decision-making skills
Preferred
Experience with rare disease and NDA/BLA submission
Strong knowledge of therapeutic area and acute care/hospital trial settings
Company
Capricor Therapeutics, Inc.
Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.
51-200 employees
H1B Sponsorship
Capricor Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$329.5MKey Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M
Leadership Team
AJ Bergmann
Chief Financial Officer
Recent News
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2025-12-17
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2025-12-09
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