About this role
SystImmune is a leading clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). The company has multiple assets in clinical trials for solid tumor and hematologic indications, plus a robust preclinical pipeline.
The biostatistician collaborates with senior biostatisticians on clinical or non-clinical studies. Leverage data science and statistics expertise to support data cleaning, visualization, analysis, and reporting for new drug discovery efforts. This role requires full-time onsite presence at the Redmond, WA office.
Work closely with clinical teams on study design, protocol development, and project meetings. Oversee CRO programming and ensure data integrity in deliverables like SDTM and ADaM. Some evenings required due to collaboration with teams in China.
Join ongoing clinical trials and cutting-edge biologics development. Gain hands-on experience in regulatory guidelines, industry standards, and oncology therapeutics. Contribute significantly to the company's success while learning and growing professionally.
Requirements
- Master’s Degree with 3+ years of statistical work experience or PhD in Biostatistics, Statistics, or related field
- Fluency in Mandarin
- Experience with statistical programming such as SAS, R, Python
- Experience with CDISC and CDASH standards
- Strong knowledge and experience in clinical trial design and data analysis, with ability to communicate statistical concepts
- Strong knowledge in applied statistics and data analysis methodology including regression modeling, categorical data analysis, survival analysis
- Strong knowledge of clinical research, drug development process, and medical terminology; oncology experience preferred
- Excellent oral and written communication skills and presentation skills
Responsibilities
- Provide data-driven insights and statistical support to clinical teams, participating in project team meetings
- Collaborate with clinical teams on study design and clinical study protocols development
- Develop, validate, and maintain programs (e.g., SAS) and conduct data analysis using SAS, R, or other software to generate TLFs
- Conduct and interpret interim analysis, including statistical and pharmacokinetics analysis, to support clinical decision making
- Develop and review SAP, including table/listing/figure shells, and review final SAR and CSR
- Oversee and validate CRO programming activities, ensuring accuracy in SDTM, ADaM, SAS tables, listings, and figures
- Conduct quality control of project deliverables, ensuring compliance with data integrity and reporting standards
- Perform simulations and ad-hoc statistical analysis when needed
Benefits
- Expected base salary range of $80,000 - $140,000 annually
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