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Associate Director, Biostatistics

Brisbane, CA, USA | BridgeBio

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    General Management
    Biotech/R&D/Science
  • Experience:
    5-7 years
    7-10 years
    10-12 years
Job Description:
96 people have viewed this job

Reporting to the Director of Biostatistics, this individual provides statistical support with minimum supervisory direction on a daily basis. Supporting clinical development, the individual will work with the clinical and regulatory team in designing clinical trials and developing the statistical analysis plan, facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/ manuscripts, perform statistical functions for submission related activities and serve as internal statistical expert in the overall program. The position will participate in process improvement, training, SOP development, enhancing statistical technical expertise and mentoring junior statisticians as a senior member of biostatistics department.

Responsibilities:

Perform duties of a project or trial statistician to support multiple clinical development projects/trials

Provide statistical input during protocol development to ensure adequacy of proposed study designs with respect to statistical feasibility

Develop statistical sections of study protocol and statistical analysis plan

Perform statistical analyses of data and interpret results to ensure validity of conclusions

Ensure achievement of statistical deliverables and milestones in coordination with other functions including clinical research, statistical programming, regulatory, data management, and medical writing

Guide CRO biostatistics for outsourced projects, and assure compliance with the specifications by reviewing/validating vendors' deliverables

Collaborate 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

Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation

Interact with medical writing in development of statistical and integrated clinical/statistical reports and other documents containing statistical information

Contribute to the development of functional-level standards, tools, and templates

Education, Experience & Skills Requirements:

Master in Statistics or Biostistics with 10+ years biotechnology/pharmaceutical biostatistics experience or Ph.D. in Biostatistics or Statistics with 6+ years biotechnology/pharmaceutical biostatistics experience

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


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