Manager Biostatistics
TalentBurst, an Inc 5000 company, Bothell, WA, United States
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
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
KNOWLEDGE, SKILLS AND ABILITIES
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
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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
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
KNOWLEDGE, SKILLS AND ABILITIES
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
#J-18808-Ljbffr