Principal Biostatistician

Description

Position at Seagen

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary:

The Principal Biostatistician is an individual contributor role that specializes in creating clinical study designs, performing data analysis, providing data interpretation, and contributing to clinical publication and regulatory submissions. Additionally, the role provides statistical and strategic inputs to clinical development planning and contributes to departmental or cross-functional initiatives to enhance business processes and improve efficiency.

Principal Responsibilities:

• Serve as a study statistician for assigned clinical studies related to one or more clinical programs
• Provide statistically sound experimental design and data analysis strategies to meet project objectives and regulatory requirements
• Provide statistical and strategic inputs on clinical development plans
• Contribute to the development of clinical study protocols and author the statistical sections
• Develop statistical analysis plans and create table, listing and figure shells for clinical trials
• Develop SMC/DMC charter as needed
• Develop study randomization specification and verification documents as necessary, work with the randomization statistician to generate randomization schedules and ensure that the randomization and blinding/unblinding process is properly followed
• Perform sample size calculations and assess trial design operating characteristics
• Review CRFs and edit checks and participate in UAT
• Review dataset programming specifications, key derived variables, and statistical deliverables
• Perform the analyses of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community by contributing to the clinical study reports, clinical publications, conference posters and presentations
• Review and contribute to study and project timeline and provide statistical deliverables in a timely manner
• Provide statistical leadership in clinical study team
• May independently present at department, project team, or Sr. Management meetings
• May lead inter-department projects involving other contributors
• Other duties as assigned

Required Qualifications:

• Demonstrates proficiency (teaches others, makes improvements) in key areas of responsibility, which is typically associated with a PhD in Biostatistics or Statistics and 2+ years of experience in clinical trials
• Proficient in: FDA/EMA or other regulations ICH GCP guidelines Drug development process CDISC standards and implementation guides Statistical methods and applications to clinical trial design and data analysis Programming skills in R and/or SAS Company SOPs and business practices
• Demonstrated ability to: Develop and deliver multi-mode communications (., written, verbal, presentations) that convey a clear understanding of the unique needs of different audiences Take on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm Attend to details Consistently achieve results, even under tough circumstances Adapt approach and demeanor in real time to match the shifting demands of different situations Build partnerships and work collaboratively with others to meet shared objectives Make sense of complex, high quantity, and sometimes contradictory information to effectively solve problems

Preferred Qualifications:

• Oncology experience
• Submission experience
• Strong statistical research and simulation skills experience

The hiring pay range for this position is $154,000 to $199,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire and an annual bonus.