Principal Biostatistician

2 weeks ago

IND Chennai Office India Pfizer Ltd Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Principal Biostatistician

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.

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.
  • Accountable for study level statistical deliverables on assigned projects.
  • Ensure that all study 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.
  • 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.

This is an individual contributor role.

BASIC QUALIFICATIONS

  • Advanced degree (Masters, PhD) in Statistics, Biostatistics, or related field.
  • 5-8 yrs. of relevant experience for master's level, entry level Ph.D. as long as the Ph.D. research work is in a relevant area.
  • Experience in clinical trials is necessary for Master's degree, desirable for Ph.D.
  • Strong statistical skills with application to clinical trials.
  • Effective verbal and written English communication skills in relating to colleagues and associates both inside and outside the organization.

PREFERRED QUALIFICATIONS

  • Working knowledge of SAS, R

ORGANIZATONAL RELATIONSHIPS

  • Works with Data Sciences and Analytics (DSA) functional lines (Stats, AQDS and SDSA) and with different therapeutic areas.
  • Works with statisticians and project teams in clinical development and medical affairs.
Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical Experience LevelSenior Level

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