HomeClinical TrialsManager Biostatistics | Pfizer Ltd | Chennai

Manager Biostatistics | Pfizer Ltd | Chennai

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Position: Manager Biostatistics

Location: Mumbai, Maharashtra

Job Description:

Role Summary:

  • Design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer standards, and best practices.
  • Provide statistical expertise and contributions for projects and protocols in support of clinical development.
  • Provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables.
  • Provide statistical expertise in maximizing the value of aggregate clinical data in support of scientific and drug development strategies.

Role Responsibilities:

  • Provide statistical input to study designs, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues, and scientific and commercialization projects
  • Provide planning, delivery, and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, support for publication activities, scientific presentations, and support to product defense.
  • Accountable for study level and submission level statistical deliverables on assigned projects.
  • Ensure that all study and project-level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
  • Provide statistical input to cross-functional activities – collaborate with other statisticians, study managers, and other colleagues – for assigned studies and regulatory submissions
  • Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects.
  • Comply with all statistics and quality processes and standards that are applicable to statistical outputs, and support processes that require statistical input.
  • Communicate and collaborate with other project statisticians within the therapeutic area to ensure consistency of statistical approaches
  • Participate in technical forums on statistical methodology and its applications pertinent to business needs.
  • Help maintain a strong statistics community at Pfizer through collaborations, scholarship, presentations, and learnings across divisions

Basic Qualifications:

  • Advanced degree in Statistics, Biostatistics, or related field.
  • Capability to provide statistical leadership to cross-functional teams at the protocol level.
  • Strong statistical skills with application to clinical trials and/or analysis of observational studies
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.

Experience:

  • At least 4 years of relevant clinical trial and business experience

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