Executive Director, Biometrics at Cardurion Pharmaceuticals, Inc.

Burlington, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Jul, 26

Salary

320000.0

Posted On

23 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biostatistics, Statistical programming, Pharmacometrics, Data management, Clinical trial design, Regulatory submission, People management, Strategic leadership, CDISC standards, FDA regulations, EMA regulations, Modeling and simulation, Protocol development, Cross-functional collaboration, Vendor management, Risk mitigation

Industry

Biotechnology Research

Description

Description Why join Cardurion Pharma? We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease. We have built a pipeline of novel therapeutic product candidates that have the potential to address the significant morbidity and mortality that remains for patients suffering from cardiovascular disease. We invite you to explore our website to learn more about our Company and how we are advancing towards our goal of building a world-class biotechnology company that discovers, develops and commercializes life-changing therapeutics for patients with cardiovascular disease. The Role: Responsible for planning, implementing and overseeing the delivery of biostatistics, statistical programming, pharmacometrics, and data management activities for one or more of Cardurion’s clinical development programs. This role will lead Biometrics activities for assigned program(s), overseeing the assigned biometrics team(s), and working collaboratively with cross-functional teams and external partners to ensure that all Biometrics deliverables are accurate, timely, consistent, and executed with the highest quality standard for regulatory success. Here’s What You’ll Do: Design clinical trials and oversee biometrics activities performed by consultants and CROs, including: · Lead statistical, pharmacometrics, and methodology activities for target product profiles, innovative study design, modelling and simulation, sample size calculation, drafting of synopses, protocols, case report forms, statistical analysis plans, briefing books for agency submission, and written/direct agency interactions. Review and contribute to final study reports and publications to ensure appropriate use of statistical and data management procedures and interpretation. · Assume overall biometrics responsibility for assigned program(s), ensuring the successful integration and oversight of the biometrics team(s) on the program(s), including oversight of external biometrics vendors, and ensuring the quality and timeliness of deliverables, and alignment with program objectives. · Work collaboratively with cross-functional teams and external partners to meet the regulatory (including ICH GCP) and operational needs of assigned program(s), and mitigate risks. · Identify opportunities to improve the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output. Evaluate biometrics tools to efficiently and effectively meet program needs. Here’s What We’ll Bring to the Table: Highly competitive benefits package including: Blue Cross Blue Shield PPO, Delta Dental, and VSP vision Fully funded HSA for high-deductible PPO Plan 401k (traditional and Roth offered) with 100% match on first 4% deferred. Match is vested immediately A suite of Cardurion paid insurance coverage, including: life insurance, short-term and long-term disability Flexible Spending Accounts for medical and dependent care expenses 4 weeks Paid Time Off annually 11 company paid holidays and Year-End shut down Our Mission: Translate our world-class expertise in cardiovascular signaling pathways into potentially groundbreaking therapeutics for patients. Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Requirements Here’s What You’ll Bring to the Table: · Education: PhD in Biostatistics or related scientific discipline. · At least 15 years of experience in biometrics or related area within the biopharmaceutical industry, including at least 5 years of experience designing and implementing innovative trial designs, at least 5 years of people management experience, and at least 3 years of experience managing multiple functions. · Proven track record of leadership in drug development, from early-stage research through to regulatory submission and approval. · Extensive experience driving strategic discussions with executive leadership, statistical regulatory strategy, and direct interactions with global regulatory agencies and health authorities, particularly the FDA and EMA. · Experience in conducting Phase 1-4 clinical trials and integrated analyses for NDA/BLA/MAA. · Thorough understanding of, and hands-on experience implementing CDISC standards. · Strong analytical and problem-solving skills, with expert knowledge of clinical trial design, statistical methodologies, and regulatory guidelines. · Strong executive presence, focus and drive to succeed, confidence, passion, and high energy. Excellent leadership skills with the ability to inspire, lead, manage, collaborate, and motivate others in a multi-functional matrix environment. · Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively. Pay Range $290,000-$320,000

Responsibilities

The Executive Director will oversee biostatistics, statistical programming, pharmacometrics, and data management activities for clinical development programs. This role involves leading biometrics teams, managing external vendors, and ensuring all deliverables meet regulatory standards for global submissions.