Director, Biostatistics

DIRECTOR, BIOSTATISTICS

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.

POSITION SUMMARY:

As the Director, Biostatistics you will be Day One’s first Statistics hire to work in collaboration with the Head of Biometrics to build the Statistics team and to enforce the appropriate standards across all statistical support throughout the organization. This hire will be responsible for serving as the Statistical representative among our cross-functional teams to contribute to the design & execution of clinical studies; will also be responsible for managing, planning, and tracking the Statistical activities and coordinating the external statistical FSP and internal resource to ensure corporate, and departmental goals are met.

This position has the potential to be fully remote. Occasional travel may be required for in person meetings.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Serves as statistical lead for oncology clinical trials; develop trial design options and provide high quality decision support
Evaluate and implement innovative designs and novel statistical methodologies as appropriate for clinical studies
Act as the primary contact and provide oversight for all statistical related activities outsourced to CROs and external vendors. Work collaboratively with CRO vendors, Clinical Research, Drug Safety, Regulatory, Clinical Operation, and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting
Applies knowledge of regulatory requirements regarding statistical principles to ensure the company meets its regulatory, scientific, and business objective
Serves as statistical lead for oncology clinical trials; develop trial design options and provide high quality decision support
Collaborates with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company
Review data collection strategies and instruments, database design, edit check specifications, external data transfer specifications, and SDTM mapping as needed
Prepare and/or review in detail the Statistical Analysis Plan (SAP) including development of standardized well-presented mock-up displays for Tables, Listings, and Figures (TLFs), conduct data analyses, and oversee preparation of all TLFs (including review of work by programmers), as well as preparation of the clinical study report
Create or review programming specifications for analysis datasets and TLFs, including SDTM and ADaM specifications
Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, TLFs, study reports, manuscripts, and regulatory submission documents
Oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical studies
Conduct hands-on exploratory analyses, sample size computation, modeling and simulation, and create tools to gain meaningful insights from trial data as needed
Interpret, summarize, and present data and statistical considerations to internal study team, senior management, advisory boarding meetings and global health authorities
Develop and maintain all biostatistics related SOPs and guideline documents
Keep abreast of new developments and advancements in statistics, drug development, science, and regulatory guidance
Able to effectively work within a team and independently
Provide leadership and direction for department strategic initiatives
Work with Head of Biometrics, Senior Management and Human Resources to identify and justify resource needs, develop staffing plans, and support recruiting
Travel may be required (up to 15%)

QUALIFICATIONS

PhD degree in Biostatistics or equivalent
8+ year (or MS degree with 12+ years) of experience in pharmaceutical/biotech industry
Extensive knowledge of statistical methodology and its application to solve problems in the pharmaceutical/biotechnology industry
Proven competencies in interaction with health authorities (such as FDA, EMA, PMDA) and eCTD (NDA/BLA) regulatory submissions
Experience working in a quality regulated environment with a thorough understanding of GCPs
Extensive hands-on experience in oncology drug development including design and analysis of early and late phase oncology trials
Excellent programming skills in SAS/R
Familiarity with industry data standards, including CDISC, SDTM and ADaM data models
Good understanding of the business beyond the area of Biostatistics and is a recognized authority outside of the company
Demonstrated effective verbal and written communication skills and interpersonal skills
Makes effective decisions with limited information
Ability and interest to work cross functionally
Ability to use professional concepts to achieve objectives in creative and effective ways
Experience in managing multiple projects
People management experience is preferred, but not required
Experience working with Oncology trials and NDA or BLA submission experience is highly desirable

KNOWLEDGE/SKILLS/ABILITIES:

Self-motivated, flexible and creative leader, able to prioritize, multi-task and work in a fast-paced and demanding environment
Superior communication skills: oral, written, with proven negotiation skills, and strong time-management. A critical and logical thinker with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution.
Sound understanding of information management concepts and tools needed to carry-out Statistical priorities, and a practical understanding of evolving technologies in support of all business areas.
Advanced knowledge of pharmaceutical development across all stages, with the ability to understand and interpret data/information and its practical application.
Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment.
Experience working with external vendors
NDA submission experience within oncology in a lead role is required

*The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

DISCLAIMER

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.

Recruitment & Staffing Agencies: Day One Biopharmaceuticals do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HRteam. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.