Our client is a clinical-stage biotechnology company developing medicines through its proprietary approach to synthetic biology. Their pipeline includes its lead program which has demonstrated proof of concept with plans to start a pivotal, Phase 3 study in the first half of 2023, and additional novel drug candidates designed to treat other rare diseases. The rapid advancement of these potential biotherapeutics proprietary, reproducible, target-specific drug design uses programmable, precision genetic engineering of well-characterized probiotics to exert localized activity for therapeutic benefit, with a focus on metabolic and immunologic diseases.
The newly created role of Head of Biometrics will be responsible for creating and implementing the strategic direction for biostatistics, programming, and data management collection activities across the pipeline, and for ensuring that proper statistical analyses and interpretations are carried out. S/he will be responsible for developing functional infrastructure and building the biometrics capabilities and, in collaboration with the Chief Medical Officer, will influence the long-term strategic direction for Biometrics. The Head of Biometrics will be a key contributor to the long-term planning for the organization and directly accountable for key milestones that support corporate objectives.
As is typical within a small team, the Head of Biometrics will combine a heavy hands-on component along with leadership and oversight of team activities. The successful applicant will also play a foundational role in the development strategy for all programs as well as all regulatory and health authority interactions, whilst forming and leading a small team in biostatistics, data management and programming.
- Develop, implement, and drive evolution of statistics, programming, and data management capabilities
- Serve as a strategic partner working closely with clinical development and other relevant functional groups in providing statistical input to clinical development plans and trial designs
- Serve as the point of escalation for all biometric functions to ensure the timeliness and accuracy of biometric deliverables
- Provides support in working with regulatory submissions, responses to regulatory authority questions, and preparation for regulatory authority meetings (eg, advisory panels or other meetings)
- Present analyses to internal and external audiences (eg, regulatory agencies, collaborators, investigators, vendors, alliance partners, etc.)
- Responsible for the development of statistical analysis plans/reports/models, to include statistical methodology (including authoring), statistical programming procedures, and production of tables, listings and figures, either directly or through management of CROs
- Provide expert statistical review/Q.C. and input into statistical deliverables (ie, analysis plans, table shells, programming and table specifications, data review, and statistical sections for integrated reports) and data management deliverables (ie, database design, critical data checks and validation)
- Provide input on relevant sections of study protocols and regulatory documents including endpoint specification, estimands, study logistics, sample size determination/justification, randomization plans, interim analyses, stopping rules (if applicable)
- Oversees the operations and procedures for the collection, editing, verification and management of data
- Manages data release and review for clinical projects; reviews and participates in QC and finalization of various documents, including abstracts, posters, manuscripts, publications, press releases, study reports, regulatory documents, etc.
- Provides leadership to team members including managing performance, developing people, hiring, and integrating new team members and fostering company culture, mission, vision and values.
- Define and develop Biometrics departmental process, SOPs and efficiencies within a small but growing team
Skills and Experience
- PhD in statistics or related field; candidates with a Master’s Degree and very significant prior experience will be considered
- Ten years of experience in pharmaceutical, biotech, or equivalent
- Five years of experience leading a statistical or biometrics function
- Experience with regulatory agencies; prior record of regulatory approvals preferred
- Prior people management experience and experience identifying organizational needs (talent, process, technology) is required.
- Intellectual curiosity and dedication to statistical science, innovation, and complex problem-solving
- Navigates change and uncertainty; is agile in responding to feedback from within and outside the organization
- Collaborates and looks to support other leaders; sees value in championing the work of the group over the individual
- Knowledge of the drug discovery and development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical/biotech industry
- Excellent written communication skills, including competent grammatical/technical writing ability
- Excellent oral/interpersonal communication skills, including public speaking/presenting ability
- Advanced proficiency using statistical computing platforms in the pharmaceutical area (eg, SAS)
- Strong working knowledge of statistical data analysis and data management principles, including knowledge of relevant Data Standards (eg, CDISC/ADaM)
- Experience with database systems, in writing scientific protocols, analysis plans and clinical study reports.