Executive Director, Biometrics

Cardurion Pharmaceuticals, Inc.•Burlington, MA

About The Position

Cardurion Pharma is a clinical-stage biotechnology company focused on discovering and developing new therapeutic approaches for cardiovascular disease. They have a pipeline of novel therapeutic product candidates aimed at addressing significant morbidity and mortality in patients with cardiovascular disease. The company's mission is to translate world-class expertise in cardiovascular signaling pathways into potentially groundbreaking therapeutics. The Executive Director, Biometrics will be 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 involves leading Biometrics activities for assigned programs, overseeing the biometrics team(s), and collaborating with cross-functional teams and external partners to ensure all Biometrics deliverables are accurate, timely, consistent, and meet the highest quality standards for regulatory success.

Requirements

PhD in Biostatistics or related scientific discipline
At least 15 years of experience in biometrics or related area within the biopharmaceutical industry
At least 5 years of experience designing and implementing innovative trial designs
At least 5 years of people management experience
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

Responsibilities

Design clinical trials and oversee biometrics activities performed by consultants and CROs
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

Benefits

Highly competitive benefits package
Blue Cross Blue Shield PPO
Delta Dental
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