Associate Director Biostatistics
The Senior Manager / Associate Director Biostatistics performs duties of a project or trial statistician to support clinical development projects/trials as required. The person provides statistical input and guidance into the development of clinical protocols, and assures well-designed clinical trials; provides statistical expertise to analyze, interprets and communicates the results of clinical trials and (non) clinical experiments. The role also takes on statistical responsibility in the preparation of regulatory interactions. The main area of experience preferred is late stage oncology trials (i.e. phase 2 or 3). Industry experience is required. Must have good communication skills, ability to collaborate across functional areas and solid clinical statistical experience.
Reports to: Head of Biostatistics and Programming
Location: Westlake Village / Thousand Oaks (NW Los Angeles) strongly preferred, South San Francisco possible.
Performs duties of a project or trial statistician to support multiple clinical development projects/trials. Provides statistical input during protocol development to ensure adequacy of proposed study designs with respect to statistical feasibility. Develops statistical sections of study protocol and statistical analysis plan. Performs statistical analyses of data and interpret results to ensure validity of conclusions. Ensures achievement of statistical deliverables and milestones in coordination with other functions including clinical research, statistical programming, regulatory, data management, and medical writing. Guides CRO biostatistics for outsourced projects, and assure compliance with the specifications by reviewing/validating vendors' deliverables. Collaborates with data management and clinical operations over the course of trials to provide statistical input to study conducts and database development as well as data collection/cleaning. Collaborates with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation. Interacts with medical writing in development of statistical and integrated clinical/statistical reports and other documents containing statistical information. Contributes to the development of functional-level standards, tools, and templates. Role model for Atara’s Values of patients first, innovation teamwork, community and mindset.
Travel: Travel required (up to 10%)
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office or clinical environment.
Minimum 5 years of experience with at least 3 years of experience of industry experience is required; experience in oncology is strongly preferred. Excellent written and verbal communication skills. Thorough knowledge of statistical methodology, processing clinical trial information and drug development process. Knowledgeable of regulatory (e.g., FDA, ICH) requirements. Experience supporting regulatory submissions in the US and EU and dealing with requests from Health Authorities. Experience in industry data standards, such as CDISC/SDTM and ADaM. Ability to review, understand, and work with data from multiple sources. Project management skill from statistical perspective. Understand responsibilities of other functional areas (e.g., statistical programming, clinical, data management, medical writing) and work with their representatives. Evidence of strong teamwork capabilities. Proficient with SAS, and R or other statistical software.
Graduate degree in Statistics, Biostatistics, or equivalent.