Senior Director, Head of Biometrics
Description

    

Job Summary

The Head of Biometrics is responsible for developing and overseeing the biometrics function for Marengo’s rapidly expanding clinical portfolio of therapeutics. The successful candidate will play a key role in strategizing and executing the clinical development programs during the life cycle of Marengo’s products. As a senior leader and subject matter expert, this individual will provide statistical expertise in keeping with the latest cutting-edge methodologies to inform decision-making across the portfolio and at the project level, ensuring the conduct of sufficient and rigorous statistical analyses, adequate and objective interpretation, reporting and publishing the study results. This role is also accountable for overseeing the CROs in delivering proper, high-quality statistical activities for all studies. The successful candidate will have the ability to bring creative/innovative clinical designs to define and apply the most effective approach across Marengo’s R&D pipeline, while working closely with drug development teams (e.g., drug discovery, immunology, clinical development, clinical operations, regulatory, safety and pharmacovigilance). This position will report to the Chief Development Officer.


   

Responsibilities and Duties  

· Ensure advanced and innovative statistical concepts are routinely applied across the design/experimental strategy, analysis, and interpretation phases of both preclinical and clinical studies to improve the quality and productivity of Marengo’s pipeline 

· Plan, organize, and execute biometrics activities associated with all regulatory submissions (pre-IND, IND, NDAs/BLAs, post-marketing submission), for example, statistical analysis plan, analysis specifications for clinical trial documents and reports, protocols, investigator brochures, as well as preparation of submission data packages compliant with regulatory standards; Review and analyze safety reporting, perform biomarker analyses and other aspects of clinical trial monitoring

· Represent Marengo as the senior statistical executive for Health Authorities (e.g., FDA, EMA, NMPA, etc.) and participate in all regulatory meetings for clinical programs and interactions with Health Authorities; Serve as Marengo’s primary contact for addressing requests from, and resolving biometrics-related issues raised by, Health Authorities, Institutional Review Boards, and local Institutional Ethics Committees 

· Provide high-level updates and advice to senior management, including evaluation and interpretation of clinical trial study design and their potential impact on Marengo’s programs and clinical/regulatory strategy

· Lead CRO and vendor interactions for biostatistics, statistical programming, and data management functions, and ensure timely delivery of CRO expectations 

· Maintain knowledge of regulations and regulatory guidance of Health Authorities, new programming and database technologies and standards

· Use statistical expertise to influence both internal and external stakeholders with the aim to improve the quality of internal decision making.

· Plan and document computer data file structure; Develop, program, manage, and maintain complex statistical databases; Perform or supervise data entry

· Use a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data; Advise and assist in the development of inferences and conclusions, as appropriate

· Monitor all external data management functions and monitor efficient work of all internal and external bio-analysts and programmers

· Conduct QC activities when needed


Requirements

   

Qualifications and Skills

· Ph.D. or master’s degree in Statistics, Biostatistics or related discipline

· At least 8-10 years of experience in the pharmaceutical/biotechnology industry in oncology clinical development; immuno-oncology (I/O) experience highly preferable

· Comprehensive expertise and demonstrated experience in drug development of all phases and approvals, including knowledge of interfaces and interdependencies of clinical development with other functions

· Experience handling data management and statistical programming components including SAS, CDISC (e.g., SDTM and ADaM), EDC systems and R (for simulations) or other statistical software

· Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA

· Knowledge and understanding of the principles, concepts, methods, and standards of statistical research

· Ability to consult with scientific investigators, interpret research requirements, and determine statistical analysis strategies

· Demonstrated experience in working with CROs

· Knowledge of scientific reporting and manuscript preparation requirements and standards

· Strong analytical communication, critical thinking and problem-solving skills

· Excellent time management skills and ability to prioritize projects

· Strong focus and quality and timely delivery of work

· Experience contributing to multiple projects in a highly collaborative, multi-disciplinary team setting


  

Marengo is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.