Cardurion Pharmaceuticals, Inc.
Executive Director, Biometrics
Cardurion Pharmaceuticals, Inc., Burlington, Massachusetts, us, 01805
Why join Cardurion Pharma?
We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease. Our pipeline includes novel therapeutic candidates aimed at reducing morbidity and mortality in cardiovascular patients. Learn more about our mission and progress by exploring our website.
The Role
The Director of Biometrics will lead planning, implementation, and oversight of biostatistics, statistical programming, and data management for one or more clinical development programs. This role involves leading biometrics activities, managing teams, and collaborating with cross-functional and external partners to ensure high-quality, timely deliverables aligned with regulatory standards.
Key Responsibilities:
Design clinical trials, oversee biometrics activities, and review study reports and publications for proper statistical application.
Manage biometrics teams and external vendors, ensuring quality and alignment with program goals.
Collaborate with teams and partners to meet regulatory and operational needs, and mitigate risks.
Identify process improvements to enhance efficiency, quality, and output; evaluate biometrics tools for effectiveness.
Benefits:
Competitive benefits including health, dental, vision, HSA, 401k with match, insurance coverage, paid time off, and holidays.
Our Mission:
To translate cardiovascular signaling expertise into groundbreaking therapeutics for patients.
Cardurion is committed to equal employment opportunity and non-discrimination. We provide reasonable accommodations for qualified individuals with disabilities.
Minimum Requirements:
PhD in Biostatistics or related field.
At least 15 years of biometrics experience, including 5 years of management and 2 years managing multiple functions.
Proven leadership in drug development, regulatory interactions, and clinical trial analysis.
Extensive experience with regulatory submissions, FDA and EMA interactions, and CDISC standards.
Strong analytical skills, clinical trial design expertise, and regulatory knowledge.
Leadership qualities, excellent communication, and ability to motivate teams.
Job Details:
Seniority Level: Executive
Employment Type: Full-time
Job Function: Management and Manufacturing
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We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease. Our pipeline includes novel therapeutic candidates aimed at reducing morbidity and mortality in cardiovascular patients. Learn more about our mission and progress by exploring our website.
The Role
The Director of Biometrics will lead planning, implementation, and oversight of biostatistics, statistical programming, and data management for one or more clinical development programs. This role involves leading biometrics activities, managing teams, and collaborating with cross-functional and external partners to ensure high-quality, timely deliverables aligned with regulatory standards.
Key Responsibilities:
Design clinical trials, oversee biometrics activities, and review study reports and publications for proper statistical application.
Manage biometrics teams and external vendors, ensuring quality and alignment with program goals.
Collaborate with teams and partners to meet regulatory and operational needs, and mitigate risks.
Identify process improvements to enhance efficiency, quality, and output; evaluate biometrics tools for effectiveness.
Benefits:
Competitive benefits including health, dental, vision, HSA, 401k with match, insurance coverage, paid time off, and holidays.
Our Mission:
To translate cardiovascular signaling expertise into groundbreaking therapeutics for patients.
Cardurion is committed to equal employment opportunity and non-discrimination. We provide reasonable accommodations for qualified individuals with disabilities.
Minimum Requirements:
PhD in Biostatistics or related field.
At least 15 years of biometrics experience, including 5 years of management and 2 years managing multiple functions.
Proven leadership in drug development, regulatory interactions, and clinical trial analysis.
Extensive experience with regulatory submissions, FDA and EMA interactions, and CDISC standards.
Strong analytical skills, clinical trial design expertise, and regulatory knowledge.
Leadership qualities, excellent communication, and ability to motivate teams.
Job Details:
Seniority Level: Executive
Employment Type: Full-time
Job Function: Management and Manufacturing
#J-18808-Ljbffr