Biostatistician

SystImmune Inc. is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.

Position Objective:

The biostatistician will collaborate with the senior level biostatisticians on clinical or non-clinical studies. The successful candidate for this position will leverage data science and statistics expertise to support the data cleaning, visualization, analysis, and reporting for new drug discovery efforts.

Main Job Responsibilities:

• Provide data-driven insights and statistical support to clinical teams, offering guidance on data-related challenges and participating in project team meetings as needed.
• Collaborate with clinical teams on study design and clinical study protocols development.
• Develop, validate, and maintain programs (eg. SAS program) and conduct comprehensive data analysis using SAS, R, or other statistical software to generate TLFs as needed.
• 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 internally or externally produced SDTM, ADaM, SAS tables, listings, and figures.
• Conducts quality control of project deliverables, ensuring compliance with data integrity and reporting standards.
• Perform simulations and ad-hoc statistical analysis when needed.
• Understand and apply regulatory guidelines and industry standards practices on statistics and SAS programming.

Qualifications:

• Master’s Degree or PhD in Biostatistics, Statistics, or related field.
• 3+ years of statistical work experience.
• 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, etc.
• Strong knowledge of clinical research, drug development process, and medical terminology, and oncology experience preferred.
• Excellent oral and written communication skills.
• Excellent presentation skills.

SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

SystImmune is an Equal Opportunity Employer.