Associate Director, Statistical Programming

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically 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.

The Associate Director, Statistical Programming will be responsible for leading Statistical Programming activities for multiple clinical studies ensuring timely deliverables with high quality and coordinating with external Statistical Programming FSP. Successful candidates will oversee the quality and management of CRO's work, as well as collaborate regularly with internal stakeholders. The Associate Director, Statistical Programming will also assist with development of Statistical Programming processes and workflows. This position will report to the Senior Director, Head of Statistical Programming.

This is a hybrid position (2-days onsite in Brisbane HQ, 3-days remote).

• Validate and create SDTM, ADaM, and Tables, Figures, and Listings (TFLs), including associated documentation like define.xml using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS and R programming

• Write or review data specifications for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) staying current on emerging regulations, requirements and guidance that relate to FDA data submission standards

• Oversee and work directly with CROs to provide guidance and effectively monitor their deliveries for quality, time, and budget adherence

• Hands-on Statistical Programming to support CSR, publications, presentations, DSUR, IB update, safety data review, reconciliation, and ad hoc analyses

• Implement and contribute to Statistical Analysis Plans and TFL shells

• Provide additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design, and data collection by review of key study documents including but not limited to the study protocol, Data Management Plan, edit check specifications, and annotated CRFs

• Support the development and implementation of programming SOPs and work instructions

• Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements

• Review and file study documentation in the Trial Master File (TMF)

• Seek continual improvement; creates or modifies processes to improve effectiveness, efficiency, communication, or compliance

• Work on multiple tasks at same time and prioritizes tasks to meet timelines on a regular basis

• Maintain effective communication with all relevant functions including but not limited to Biostatisticians, Data Management, Clinical Operations, Clinical and Safety Science, PK Science, and Regulatory

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

• Act independently to determine methods and procedures on new assignments

• Create tools to improve programming efficiency or quality

• MS, BS/BA degree in Statistics, Mathematics, Computer Science or other suitable qualification related to the field (MS preferred)

• 8+ years of Statistical Programming experience in the pharmaceutical industry

• Experience working with oncology trials and NDA or BLA submission experience is highly desirable (experience in pediatric oncology a plus)

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

• Proficient in R programming is highly desirable

• Extensive experience managing CROs for clinical and Statistical Programming activities

• Broad knowledge of medical/biological terminology in relevant therapeutic areas, good knowledge of drug development regulations for statistical analysis

• Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation

• Excellent communication and interpersonal skills, with the ability to effectively develop and deliver strategically, while aligning and gaining the collaboration of cross-functional groups

• Able to effectively lead functional and cross-functional projects of varying scope and complexity while prioritizing resources

• Strong hands-on programming skills to deliver results in a fast-moving environment

• Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels, work is performed in an office environment

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

The salary range for this position is $175,000 - $190,000 Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.

Please visit https://www.dayonebio.com/benefits to see our competitive benefits.

Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.

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 a sincerely held religious belief.

Recruitment & Staffing Agencies: Day One Biopharmaceuticals does 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 HR team. 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.