Company Description|Job Description
ABOUT OUR COMPANY
Guardant Healthis a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs.
In pursuit of our goal to manage cancer across all stages of the disease,Guardant Healthhas launched two liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, & is developing programs for recurrence & early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
The Biostatistician, CDx/IVD is responsible for providing strategic & statistical expertise to our expanding portfolio of CDx/IVD studies . The Biostatistician, CDx/IVD serves on project committees, engages with internal & external stakeholders as a member of the Clinical Development team, & is responsible for the developing & executing on the full scope of biostatistics processes in support of CDx/IVD studies.
Essential Duties & Responsibilities:
- Provide statistical support on multi-disciplinary team to support clinical development initiatives ranging from prospective study design to statistical oversight of CDx/IVD studies
- Plan & write statistical sections of clinical & diagnostic protocols, perform & document statistical analyses (i.e. in SAS & other programs as appropriate) on clinical study data. Ensure team understands statistical risks of all sampling plans used.
- Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data-handling rules, & mockups.
- Summarize data analysis results orally & in written form
- Contribute to publication figures/writing/editing & QC of data displays.
- Select appropriate statistical tools for addressing a given scientific question
- Support responses to statistical queries from from pharma partners or regulatory bodies regarding statistical aspects of studies
- Provide statistical input into other disciplines' activities & participate in interdepartmental processes with Regulatory Affairs, Bioinformatics, Clinical Development, Medical Affairs, Project Management & Quality
- Effectively communicate both internally & externally to align on GCP-compliant data tranfers
- Carry out all activities according to appropriate Guardant SOPs, working within the framework of the Quality Management System & to GCP
- Maintain therapeutic knowledge
- Masters degree in Statistics or related field, preferably with a strong medical statistics component and4-6 years' related experience or PhD degree in Mathematics, Statistics or a similar quantitive field & 1-3yearsof related experience.
- Strong programming skills & knowledge of R, SAS, & JMP
- Oncology experience
- CDx and/or IVD experience, highly preferred
- Strong understanding of GCPs, ICH, & knowledge of regulatory requirements
- Solid organizational & business assessment skills is required
- Demonstrated ability to develop positive working relationships with individuals & teams internally & externallyAbility to work independently as well as part of a cross functional team & to express statistical ideas & concepts in ways understandable to non-statisticians
- Excellent problem solving ability necessary
- Excellent written & verbal communication skills
- Flexible & solution seeking attitude
- Must have working knowledge of MS Office as well as project management & clinical trials software
All your information will be kept confidential according to EEO guidelines.
This description is used as a guideline for major duties. The company reserves the right to change or assign additional duties as needed.