Biostatistician

$70,000 - $170,000/Yr

SystImmune - Redmond, WA

Full-time - Mid Level

Redmond, WA

Chemical Manufacturing

About the position

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.

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.
• Conduct 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.

Requirements

• 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.

Benefits

• 100% paid employee premiums for medical/dental/vision
• STD, LTD
• 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
• 11 paid holidays
• MORE