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 preferredPrior 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.