Cambridge, MA OR Remote
about 2 months ago
Hamlyn Williams is partnered up with a leading precision oncology company based in Cambridge, MA. The company utilizes its genome-wide, CRISPR-enabled SNIPRx platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair.
The company is growing at a rapid pace with challenging and exciting opportunities for experience professionals. So, if you’re ready to work on scientific breakthroughs where your desire to be part of a collaborative team of scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives, let’s talk.
About the Role
The Head of Biometrics will work with the Clinical Development Team to provide statistical expertise and leadership across the portfolio. This individual will be responsible for leading the Biometrics Team, overseeing the data sciences, biostatistics, programming, and data management capabilities.
The specific areas of focus for this role includes the planning, study design, conduct, analysis and interpretation of clinical trials across programs. The individual will be accountable for biometrics and data management resource and budget oversight, identifying and implementing appropriate technology requirements, process, and standard operating procedure implementation. In addition, the individual will provide statistical expertise on regulatory interaction for meetings, responses, and meeting preparation.
What You’ll Do
- Provide statistical leadership, oversight, and expertise across the organization
- Provide strategic statistical input in study design and execution of all clinical trials
- Lead, manage, and develop employees in the Biometrics Team
- Organize, and oversee or execute biometrics activities for clinical projects in support of product development and regulatory approvals
- Responsible and accountable for deliverables from the Biometrics Team including timeliness, high quality and according to regulatory and departmental standards
- Ensure statistical, programming, and data management work is performed according to Good Clinical Practices (GCP), International Conference on Harmonisation (ICH), 21 CRF part 11, international regulatory requirements and standard operating procedures
- Represent Repare Therapeutics in meetings with regulatory authorities to support statistical endpoints, analyses, and study related issues
- Responsible for the statistical and data integrity, adequacy and accuracy in the company’s clinical studies, development plans and projects.
- Define and execute the strategic vision for the Biometrics Team.
- Establish organizational and operational structure for the Biometrics department and provides supporting business case
- Establishes standards for technology and resources used within the department including policy, practices, and operating procedures
- Network and collaborate with external thought-leaders and influences internal and external decisions to ensure quality of study designs and analyses, appropriateness of inferences, conclusions, and claims
- Collaborate with researchers and thought leaders in the strategic planning of clinical development programs and the publication of study data
- Be able to conduct independent research and resolve statistical methodological issues
- Recruit, develop, and retain talent to meet department functional goals and business objectives
- Contribute to the development of clinical strategy and goals
- Collaborate with Clinical Development, Regulatory Affairs, Pharmacovigilance, Clinical Pharmacology and Translational partners across the company
What You’ll Need
- PhD in Biostatistics or Statistics with a minimum of 15 years of experience in the pharmaceutical or biotechnology industry, preferably in oncology
- Prior management experience in statistics, programming, and data management is required (at least 5 years of supervisory experience)
- Demonstrated ability to hire, oversee, and build effective teams
- Demonstrated successful leadership experience including project and people management
- Strong knowledge of clinical trial design as applicable to oncology, with a proven capability to provide strategic input in a cross-functional environment
- Strong knowledge of ICH, GCP, and drug development regulations pertinent to statistics
- Strong knowledge and technical experience in SAS applications and CDISC requirements
- Good knowledge of software applications for statistics and programming (SAS, EAST, R, S-plus, etc.)
- Good knowledge of database platforms (e.g., RAVE), CDASH, and overall build requirements Extensive experience in contributing to and acting as statistical lead in NDAs/BLAs submission, including significant interaction with both FDA and EMEA
- Excellent writing and communication skills and demonstrated leadership capabilities
- Excellent interpersonal skills and demonstrates an ability to critically problem solve
- Demonstrates an ability to take complex statistical concepts and explain them in simple forms to non-statisticians