Director / Senior Director, Biometrics
The Director/Senior Director, Biometrics will be accountable for overseeing all biometrics-related activities in support of all clinical development and medical affairs programs. Activities include advising on program statistical strategy and oversight of data management, programming, and statistical analysis to ensure the necessary capabilities and resources are in place to optimize the design, conduct, analysis and interpretation of clinical data for each of the Company programs. Will partner closely with functional leaders across the organization, including Medical Sciences, Clinical Sciences, Regulatory Affairs, Pharmacokinetics, Medical Affairs and other departments as necessary, and will represent the Biometrics function on project teams and for interactions with regulatory agencies. Will be accountable for planning and oversight of the biometrics budget, providing guidance and oversight to external consultants and CRO staff, and will identify and implement technology advances in support of biometrics activities at Venatorx.
Duties & Responsibilities:
- Responsible for the delivery, integrity and quality of clinical data across the portfolio.
- Performs as a core member of the development teams and advises the team members on statistical strategy and up-to-date biometrics methodology and tools for clinical drug development.
- Serves as the statistical and data management lead in the design, analysis and interpretation of clinical study data across early and late-stage assets and in the development and review of the study synopsis, protocol, data review plan, statistical analysis plan (including design of tables, listings, figures), clinical study report, adjudication committee and data monitoring committee reports, and other regulatory submission documents or publications, ensuring accuracy and statistical validity within the scope of the project timelines.
- Leads data management, programming and statistical activities and provides guidance/oversight of CROs/vendors, with hands on approach to ensure quality of analysis data and statistical output; reviews and approves key data management and statistical vendor deliverables.
- Following CDISC conventions, oversees eCRF design and annotation, database design specifications; develops or oversees CRO generation of data validation specifications; participates in user acceptance testing (UAT) of the clinical database, including edit check testing, as appropriate.
- Oversees study team in data review; performs data review for quality issues and general data trends, as needed; provides guidance to others on program-level data review standards.
- Defines and oversees data transfer specifications for data from external sources outside of the eCRF (e.g., central laboratory data, central ECG data, pharmacokinetics data); defines and oversees reconciliation process for external data with eCRF database.
- Provides oversight to ensure data within eCRF is of highest quality to support ongoing data reviews as well as interim and final database lock.
- Represents the company at meetings with regulatory agencies (e.g., FDA, EMA).
- Plans and directs study level analysis and reporting activities.
- Leads biostatistical technology-based advancement initiatives to support clinical development.
- Provides statistical justifications and interpretation of analysis results for actions/decisions/statements.
- Interprets and translates computational results into biologically relevant conclusions and hypotheses; discusses biological questions, problems and outcomes.
- Develops strong and collaborative working relationships with key business stakeholders (e.g., Medical Science and Clinical Science Leads, CRO/vendor data managers and statisticians, and others).
- Ph D. or M.S. in statistics or biostatistics preferred with minimum of 10+ years of experience in the pharmaceutical or biotechnology industry; infectious disease experience preferred.
- Proven capability as a successful leader in a strategic, cross-functional environment; management experience preferred.
- Extensive knowledge of clinical trial development and statistical methodology related to trial design and conduct of clinical studies is required.
- Strong knowledge of ICH, FDA, and GCP regulations and guidelines.
- Strong well-rounded technical skills with SAS, CDISC/SDTM, and Adam data models.
- Scientific background and understanding of clinical trials, clinical development operations and regulatory compliance.
- Experience negotiating successfully with health authorities.
- Strong business acumen and critical thinking skills.
- Flexible, well organized, comfortable with ambiguity.
- Excellent time management skills, ability to coordinate workload and meet established deadlines.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Strong written and verbal communication skills.
Equal Employment Opportunity/M/F/disability/protected veteran status