Head of Biometrics

LOCATION: South San Francisco

DEPARTMENT: Product Development

REPORTS TO: Chief Development Officer

Day One was founded to address a critical unmet need: children with cancer are being left behind in a cancer drug development revolution. Our name was inspired by the “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan. We aim to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One.

SUMMARY:

The Head of Biometrics is responsible for creating and implementing the strategic direction for biostatistics, real world evidence, programming, data management and eData collection activities across all projects, in all phases of development and ensuring that proper statistical analyses and interpretations are carried out. S/he will be responsible for developing functional infrastructure and in building the biometrics capabilities at Day One and, in collaboration with the Heads of Clinical Development & Regulatory Science, sets or significantly influences the long-term strategic direction for Biometrics in-line with the broader Development strategy. The Head of Biometrics will be a key contributor to the long-term planning for the Development organization and directly accountable for key milestone that support corporate objectives.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Develop, implement and drive evolution of Day One’s statistics, programming, RWE and eCOA 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
Serves as the point of escalation for all biometric functions for Asset & Study teams 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 (e.g., advisory panels or other meetings)
Presents analyses to internal and external audiences (e.g. 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
Provides expert statistical review/Q.C. and input into statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, and statistical sections for integrated reports) and data management deliverables (i.e. database design, critical data checks and validation)
Provides input on relevant sections of research protocols and regulatory documents including endpoint specification, 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.
Collaborates with partner functions to provide statistical programming, systems analysis and database management support for observational studies/projects using internal observational health related database resources
Ensures that clinical outcome assessment (COA) and patient reported outcome (PRO) data are captured using the most appropriate & efficient tools and methods.
Provides leadership to team members including managing performance, developing people, hiring and integrating new team members and fostering Day One’s culture, mission, vision and values.

EDUCATION/EXPERIENCE/SKILLS:

Education and experience:

Masters or PhD in statistics or related field
Generally has 15+ years of experience in pharmaceutical, biotech, medical device industry or equivalent; global experience strongly preferred
5+ years of experience leading a statistical or biometrics function
Demonstrated experience in early clinical development
Experience in rare disease preferred
Experience with regulatory agencies; prior record of regulatory approvals preferred
Prior people management experience and experience identifying organizational needs (talent, process, technology) is required

Knowledge/Skills/Abilities:

Setting Strategy

Demonstrates a long-term perspective that extends beyond the immediate initiatives; visualizes and articulates a clear direction for Day One during times of uncertainty
Intellectual curiosity and dedication to science, innovation, and complex problem-solving
Commitment to strategic priorities and an increasingly aligned and disciplined organizational strategy

Executing for Results

Focuses on how things are done as much as what is done; drives a culture of high performance with increased attention to discipline and process
Sets aspirational goals to take organizational performance to the next level, reinventing the operating model when appropriate; goes beyond conventional performance benchmarks to set world class best practice
Navigates change and uncertainty; is agile in responding to feedback from within and outside the organization

Leading Teams

Embraces and embodies the Day One values: “break the barriers, own your excellence, commit to collaborate, demonstrate the respect you seek, and above all, champion the patient;”
Able to learn from colleagues, embraces perspectives from different backgrounds and fields, and step back to allow others to take action
Thoughtfully leads through influence and maintains focus on larger priorities; delegates effectively while managing performance and holding direct reports accountable

Building Relationships and Using Influence

Collaborates and looks to support other leaders; sees value in championing the work of the group over the individual
Offers enthusiasm and empathy toward other leaders and their respective departmental goals; influences and ensures alignment toward common priorities
Able to connect, engage in open dialogue, disagree when necessary, and compromise toward the greater good of Day One

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
Strong independent work ethic and a willingness to be engaged with the project teams
Strong organizational skills
Strong teamworking ability
Advanced proficiency using statistical computing platforms in the pharmaceutical area
Familiarity and ability to learn alternative relevant statistical computing software
Strong analytical, detail-oriented mindset, ability to solve moderate to complex problems
Practical experience applying statistical concepts and methodologies to clinical trial design/analysis and within regulatory guidelines
Strong working knowledge of statistical data analysis and data management principles, including knowledge of relevant Data Standards (i.e. CDISC/ADaM)
Experience with database systems, in writing scientific protocols, analysis plans and clinical study reports

This role will interact on a regular basis with a variety of internal and external colleagues, including (but not limited to): other internal clinical, non-clinical, regulatory, medical, safety, R&D, and commercial personnel, external vendors (CROs, labs), investigators and investigative sites, consultants, global key opinion leaders, and global regulators.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Day One Biopharmaceuticals is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date. Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or sincerely held religious belief.