Principal Biostatistician
- Pfizer
- 5 - 8 years
- Chennai
- 4 months ago
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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.
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
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Data Science & AnalyticsRole Category: Data Science & Machine LearningRole: StatisticianEmployement Type: Full timeContact Details:
Company: PfizerLocation(s): Chennai+ View Contact
Keyskills: Medical affairs Statistical analysis Compliance SAS R Clinical trials clinical development Research Individual Contributor Statistics Analytics
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