Director, Statistical Programming

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Job description

DAY ONE BIOPHARMACEUTICALS JOB DESCRIPTION

JOB TITLE: Director, Statistical Programming LOCATION: South San Francisco

DEPARTMENT: Biometrics

REPORTS TO: VP, Biometrics

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.

SUMMARY:

The Director, Statistical Programming will be responsible for managing, planning, and tracking the Statistical Programming activities and coordinating the external statistical Programming FSP and internal resource to ensure corporate, and departmental goals are met. The Director, Statistical Programming will come in as the first statistical programming hire to build and enforce the appropriate standards in the statistical programming function.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Oversees and manages the workflow of generating study specific and ad-hoc clinical data listings, summary tables and figures.

• Maintains effective communication with data management, clinical operations, and clinical science departments.

• Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.

• Acts independently to determine methods and procedures on new assignments.

• Designs, develops, evaluates, and validates computer programs (primarily the SAS programming language) for the analysis and interpretation of clinical trial data.

• Manages creating CDISC SDTM and ADaM files, SAS transport files and Define.xml used for electronic Submission with data from EDC as well as data received in non-standard form from various sources.

• Manages the activities of data review, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.

• Reviews Data Management Plan, Data validation plan, edit check specifications and eCRF UAT.

• Interacts with statisticians and members of clinical team, performs ad hoc analysis, and generates outputs according to the requirements.

• Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.

• Recognizes inconsistencies and initiates resolution of data problems.

• Creates/acquires tools to improve programming efficiency or quality.

• Establishes monitoring of clinical and safety data for ongoing trials to identify study conduct, data quality issues, or drug safety concerns.

EDUCATION/EXPERIENCE/SKILLS:

Education:

• MS or higher degree in Statistics, Math or Scientific Discipline.

Experience:

• 8+ years Pharmaceutical/Biotech programming experience.

• Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.

• Experience with R-Shiny or Python is a plus.

• Ability to use professional concepts to achieve objectives in creative and effective ways.

• Experience in managing multiple projects.

• Experience building out a statistical programming team/department is strongly preferred

• 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 Programming 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

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.

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. 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.