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Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Prepare and review aggregate safety reports (DSURs, PBRERs, RMPs, ACOs), analyze safety data, liaise with cross‑functional global stakeholders, ensure compliance with SOPs and regulatory guidance, and drive document strategy and quality.
Top Skills:
ExcelPowerPointWord
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead asset-level clinical data management for multiple trials: set data strategies, oversee EDC/CRF design and implementation, ensure data integrity and quality, apply standards and RBM analytics, manage vendors, support regulatory inspections, and conduct data due diligence for transactions. May serve as Clinical Data Scientist/Trial Lead and manage direct reports.
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Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
The Senior Statistical Data Scientist will program statistical deliverables, collaborate with study teams, and ensure compliance with Pfizer standards, focusing on SAS, R, or Python. They will also engage in self-learning and contribute to SDSA initiatives.
Top Skills:
PythonRSAS
ROLE SUMMARY
ROLE RESPONSIBILITIES
This is an individual contributor role.
BASIC QUALIFICATIONS
PREFERRED QUALIFICATIONS
ORGANIZATONAL RELATIONSHIPS
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
- 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
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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