Head of Biometrics

Job Description

Job Description

We are partnering with a client on the search for a Head of Biometrics to join their leadership team. Reporting to the Chief Medical Officer (CMO), the Head of Biometrics will provide leadership for driving the company's Biometrics activities for all studies across the world, including management of biostatistics, programming, medical writing, and data management. This leader will shape and influence the entire portfolio and will be responsible for creating vision, leading, developing, and implementing statistical solutions to optimally support all phases of clinical trial and project decision making. The ideal candidate will have proven leadership and communication skills with a drive for delivering innovative bioinformatics-based analysis solutions across a broad range of use cases. This role requires someone with a track record of establishing a strategic roadmap for innovations across bioinformatic methods and algorithms, delivering continuous improvements in core analysis capabilities, establishing an information delivering system, and effectively working with stakeholders.

Key Job Responsibilities

Provide leadership and vision for the Biometrics team; responsible for setting, designing, and developing the vision and goals for Biostatistics, Statistical Programming, Data Management, and Medical Writing. Translate strategies and tactical plans into practical and effective actions.

Manage the development of SOPs, statistical programs, and deliverables by CROs for biostatistics, statistical programming, and data management. Collaborate with other functions to ensure data collection and reporting is done in conformance with ongoing practices and regulatory expectations.

Deliver statistically sound scientific methodology experimental design and data analysis input to meet project objectives for global regulatory organizations such as FDA and EMA. Adheres to regulatory guidelines for statistical and clinical data analysis, data structure, and new developments in statistics and drug development.

Author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents, and scientific publications; generates or reviews study randomization and sample size / power estimations.

Liaison for all statistical and operational aspects pertaining to Data Monitoring Committees.

Reports study results of appropriate statistical analyses, in collaboration with clinical development, to provide appropriate interpretation of data and sound study conclusions.

Becomes familiar with the disease states and therapeutic space to enhance the level of collaboration and be able to evaluate implications of study designs.

Leadership Attributes

Able to thrive in a fast-paced, dynamic small company environment with ability to adjust workload based upon changing priorities.

Critical thinker with a demonstrated ability to collaborate with both leadership and teams, demonstrating ability to influence, make sound decisions, and drive alignment.

Natural leader with a positive management style, combined with superior communication skills and unwavering ethics and integrity.

Proven interpersonal skills and executive presence, with an effective ability to quickly establish credibility, trust, and support within all levels of the organization.

Leads and reinforces company values and culture in day-to-day behaviors, management style, and expectations.

Self-starter, able to drive work forward within an agile environment with a track record of executing against results.

Requirements

A minimum of 15 years of progressive, relevant leadership experience in pharmaceutical or biotechnology clinical trials. Must have early development experience while full-cycle drug development / pharmaceutical experience is highly preferred.

An advanced degree MS or PhD in Statistics, or Biostatistics, or a related field.

Technical knowledge of database structure, and relevant statistical software (e.g., SAS®, East®, and R. programming) background preferable.

Experience with statistical and operational aspects pertaining to Data Monitoring Committees.

Demonstrated agility to learn, and prioritize multiple responsibilities independently, remove barriers and drive projects to completion.

Able to understand and communicate scientific data effectively at all levels and present complex and / or new ideas with clarity and simplicity. Experienced presentation skills tailored to engage and communicate with diverse audiences (investigator meetings, site personnel, KOL interactions and internal project teams).