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Manager, Biostatistics

4.00 to 6.00 Years   Chennai   09 Aug, 2021
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

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 (MS, PhD) 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.
PREFERRED QUALIFICATIONS
  • At least 4 years of relevant clinical trial and business experience
  • PhD preferred
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Medical #LI-PFE,

Keyskills :
statistical analysis plansequal employment opportunityclinical dataproject plansstudy managersclinical trialstherapeutic areadrug developmentregulatory issuesquality processesscientific reportsstatements of work sow

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