What are the responsibilities and job description for the Manager, Biostatistics position at TalentBurst, an Inc 5000 company?
Title: Manager, Biostatistics
Location: Bothell, WA
Duration: 12 Months
The incumbent is the statistical lead for multiple clinical trials. This role will work closely with cross-functional teams to ensure appropriate study design, statistical analysis and reporting, and study result interpretation of clinical trials in achieving regulatory, scientific, and business objectives.
KEY ROLE AND RESPONSIBILITIES:
- Work collaboratively with clinical science, statistical programming, clinical data management, clinical operation, drug safety, translational research, regulatory and project management to meet project deliverables and timelines for statistical data analysis and reporting
- Author statistical sections in protocols, including sample size calculation
- Author Statistical Analysis Plans, mockups, and specification of TLFs for clinical trials
- Apply advanced statistical methodologies to study design and clinical development plan
- Manage vendors and oversee statistical deliverables to ensure the quality of deliverables and ensure the timelines are met
- Perform biomarker and exploratory analyses using advanced statistical methods
- Develop and maintain SAS macros, TLF templates and programming standard
- Review and support the development of CRF design
- Participate, review, and provide statistical input on study documents, such as protocol, IB, DSUR, CSR, etc.
- Experience in biotechnology or pharmaceutical industry
- Vendor oversight experience
- Demonstrated knowledge and programming skills in SAS and/or R
- Proven experience in oncology (hematology-oncology or solid tumors)
- Exposure to, and experience in machine learning
- Solid understanding of overall drug development process and clinical trials
- Strong knowledge and understanding of ICH guidance and GCP standard
- Excellent verbal and written communication skills with the ability to facilitate conversations across teams
- Proven ability to work well in a matrix team environment
Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.
Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.
We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.
TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.