Redmond, Washington, United States (On-site)
SystImmune is looking for a Biostatistician to support clinical development and data management. This position is for a qualified biostatistician with experience in the pharmaceutical/biotechnology sector, to collaborate with cross-functional teams in clinical development.
Essential Duties and Responsibilities:
- Provide support and guidance on data and statistical-related issues to clinical team, attend project team meetings when necessary.
- Work with the clinical team on study design and clinical study protocols.
- Work with/oversee internal or external data management team on design/review of CRFs, DTS, ECs, DVP, participation in UAT and medical coding.
- Generate and review data tables/listings and coordinate data review meetings to ensure data quality.
- Generate and review interim analysis including statistical analysis and pharmacokinetics analysis to support further clinical decisions.
- Develop and review SAP, including table/listing/figure shells, and review final SAR and CSR;
- Oversee CRO programming activities, perform quality assurance checks on internally or externally produced SDTM, ADaM, SAS tables, listings, and figures.
- Conducts quality control of project deliverables, ensure the output meets expectations.
- Perform simulations and ad-hoc statistical analysis when needed.
- Understand and apply regulatory guidelines and industry standards practices on statistics and SAS programming.
- Generate/review SOPs when needed.
Education / Experience qualifications
- Master’s Degree required in Biostatistics, Statistics, or related field.
- 3+ years of statistical work experience (academia/industry).
- Experience with statistical programming such as SAS, R, Python.
- Experience with CDISC and CDASH standards.
- Strong fundamental 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, 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. Interested applicants should send their CV and cover letter to [email protected]
Are you interested in this position?