Clinical Statistician

6 months ago

Chennai Tamil Nadu, India Pfizer Full time

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 under the supervision of senior statistical staff.
- Provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables under the supervision of senior statistical staff.
- Provide statistical expertise in maximizing the value of aggregate clinical data in support of scientific and drug development strategies under the supervision of senior statistical staff.
- Provide study level statistical expertise and communicate resource needs to management and other line functions for the execution of statistical tasks.

ROLE RESPONSIBILITIES
- Through effective partnership with lead project statistician, 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.
- Develop effective collaborations and sound working relationships with others within GPD
- 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
- Provide input to management plans to support assigned studies and submissions.
- Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects.
- Ensure tracking of clinical trial/allocated project activities and milestones.
- Participate in non-clinical project activities as needed
- 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

BASIC QUALIFICATIONS
- Advanced degree (Masters, PhD) in Statistics, Biostatistics, or related field.
- 3-6 yrs relevant experience in clinical trials is desirable but not necessary.
- 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

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

Medical

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