Penfield Search Partners Ltd
Director, Analysis and Design
Penfield Search Partners Ltd - San Mateo
Work at Penfield Search Partners Ltd
Overview
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Overview
Our client is a clinical-stage biopharma company focusing in the Oncology space. They are currently seeking a highly skilled and experienced Director of Biostatistics to be responsible for managing and delivering project goals effectively, ensuring compliance and timely execution of statistical strategies for global clinical trials. Provides leadership within biostatistics function to develop and execute statistical strategy, design and analyses for clinical trials in all phases.
Applies sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements.
Develops and/or applies statistical theories, methods and software. Partners in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or reporting of data.
Develops and implements biostatistics department policies, standards, practices and work-instructions in coordination with department leader and leaders in other functions.
Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success.
Manages timelines, deliverables and budgets of contract research organizations.
Direct the statistical design, conduct, and analysis of clinical trials in all phases.
Review and or author statistical analysis plans for all phases of a trial.
Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements.
Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development.
Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
PhD in Statistics/Biostatistics or related discipline and a minimum of 8 years of related
Managed and or supported clinical trials, preferably in the therapeutic area of Oncology and in the biotech/pharmaceutical industry.
Comprehensive and detailed knowledge of: statistical experimental designs, analyses and clinical trial requirements, particularly pertaining to Oncology trials.
Experience in state-of-the-art data organization and statistical analyses using statistical software such as: R and SAS.
Applies sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements.
Develops and/or applies statistical theories, methods and software. Partners in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or reporting of data.
Develops and implements biostatistics department policies, standards, practices and work-instructions in coordination with department leader and leaders in other functions.
Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success.
Manages timelines, deliverables and budgets of contract research organizations.
Direct the statistical design, conduct, and analysis of clinical trials in all phases.
Review and or author statistical analysis plans for all phases of a trial.
Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements.
Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development.
Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
PhD in Statistics/Biostatistics or related discipline and a minimum of 8 years of related
Managed and or supported clinical trials, preferably in the therapeutic area of Oncology and in the biotech/pharmaceutical industry.
Comprehensive and detailed knowledge of: statistical experimental designs, analyses and clinical trial requirements, particularly pertaining to Oncology trials.
Experience in state-of-the-art data organization and statistical analyses using statistical software such as: R and SAS.