Located in Redmond WA, SystImmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. We are a group of highly experienced immuno-oncology scientists utilizing several technology platforms to develop world class advanced antibody-based drug therapies.
Essential Duties and Responsibilities
- Participates in identification, evaluation, selection of external CROs by driving statistical thinking (statistical assessment, project budget, contract negotiations, etc.).
- Reviews case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses.
- In conjunction with the CRO, authors or oversees authorship of Statistical Analysis Plans (SAPs) and Statistical Programming Plans (SPPs). Ensure rigorous approaches are taken to ensure good scientific practices as followed: proper statistical methods utilized in analysis plans, and assay methods are appropriately designed, blinded, and randomized to meet objectives.
- Provides statistical guidance/oversight to CRO statisticians regarding requirements and GCP standards, holding CRO accountable for the quality of their deliverables.
- Performs exploratory statistical analyses and quantifies the benefits, risks, values and uncertainties of drug research and development to make sound conclusions and propose drug development strategies.
- Responsible for data management of clinical research projects, including DMP formulation, database compilation, program verification and query clearing, participating in data audit and data export.
- Makes statistical contributions to clinical study reports, including authoring of statistical methods, data interpretation Clinical Study Reports (CSRs), and manuscripts for publication / presentation.
- Accounts for statistical activities in support of IND/NDA or other regulatory submissions. Address statistical questions/comments from FDA and other regulatory agencies, and review and address comments by IRB/ECs.
- Willingness and ability to travel domestically and internationally, particularly China, as required (approximately 10-15%).
Education and Experience
- Ph.D. in Biostatistics, Statistics, or closely related field with 10+ years of experience in clinical trials.
- Comprehensive knowledge of and experience with statistical methods and applications in study design and analysis.
- Strong understanding of statistical regulatory guidance and standards (e.g., FDA, ICH and GCP).
- Demonstrated ability to effectively oversee outsourcing CROs work.
- Solid well-grounded experience in oversight / management of bio-statistical, programming, and data management services provided by CROs.
- Demonstrates extensive experience in statistical data analysis of clinical trials (Phase 1-3) as well as integrated data analyses of safety and efficacy.
- Proficient in statistical programming (SAS and R) and other relevant statistical analysis software systems.
- Extensive experience in regulatory authority interactions and submissions.