Director, Biostatistics

Overview:

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities:

The Director of Biostatistics is responsible for the management of clinical trial data processing and strategy across SELUTION DEB trials. The Director of Biostatistics will be responsible for overseeing the design, analysis, and reporting of clinical trial data, ensuring high-quality data compliance throughout the lifecycle of a trial. This role is directly involved in the success of the organization in improving patient care and coordinating with clinical sites.

Key Responsibilities

• Biostatistical lead across SELUTION DEB clinical studies, leading all in-house statistical and programming efforts related to the studies, ensuring data integrity and alignment with regulatory standards.
• Partner with key stakeholders across Clinical and Regulatory to deliver timely, compliant, inspection-ready, high-quality data analyses for submissions and data-driven decisions
• Serve as the strategic partner working closely with other functions to ensure statistical input into strategy, design, and execution of clinical development plans and trial designs
• Responsible for authoring statistical sections of clinical trial protocols and developing the Statistical Analysis Plan; the design, analysis, and reporting of clinical trial data, ensuring high-quality data analysis and regulatory compliance
• Ensure expert statistical input/review/QC both internally (e.g., clinical studies, programs, regulatory submissions, publications) and externally (e.g., response to regulatory authorities, presentations to advisory panels)
• Collaborate with partner functions to provide statistical programming, systems analysis, and database management support for important Clinical deliverables
• Participate in the development of the clinical components of regulatory submissions and transfer of clinical data as needed, ensuring data deliverables meet regulatory submission requirements
• Oversee performance of external vendors responsible for clinical data deliverables (programming, statistics) to ensure completion of clinical data related deliverables
• Identify and drive implementation of data analysis best practices to ensure timely execution of data deliverables
• Bring expertise in implementing robust data governance frameworks, successful team management, and comprehensive understanding of regulatory requirements
• Lead development of new / streamlining procedures and process improvement (e.g., development of statistical standards such as SAPs, outputs; data sharing procedures for internal and external audiences; data QC prior to release)
• Drive development and improvement of department-level standard operating procedures (SOPs)
• Ensure all data management and statistical activities and processes follow Good Clinical Practice (GCP), relevant regulatory requirements, and SOPs and WIs

Qualifications:

Required Qualifications

• Master's degree in Statistics/Biostatistics
• 12+ years of experience in pharma/biotech/medical device industry, with in-depth knowledge of Data Management and Biostatistics processes
• 2+ years of Cardiovascular experience
• 2+ years of experience in managing a team
• Strong expertise in clinical data management for IDE/PMA clinical trials and complex study designs in medical device
• Strong working knowledge of Biostatistics processes and current statistical programming/software platforms (e.g. SAS, SPSS, MATLAB, etc.)
• Extensive experience with EDC platforms
• Knowledgeable with GCP, ICH, and FDA and other regulatory authority requirements as applicable for clinical data management
• Effective team leadership and collaboration in cross-functional study and program teams
• Excellent ability to manage, motivate, develop, and empower teammates
• Precise, rigorous, detail-oriented
• Outstanding verbal and written communication skills, in addition to excellent organizational skills
• Ability to prioritize, take independent decisions and analyze complex issues
• Strong analytical thinking and problem-solving abilities
• Ability to thrive in a fast-paced environment while remaining flexible, proactive, resourceful and efficient
• Fluent in English

Pay / Compensation

The expected pre-tax pay rate for this position is $175,400 – $250,800 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Preferred Qualifications:

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammate's points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.