Clinical Statistician - Chennai, India - Pfizer

Pfizer

Verified Company

Chennai, India

3 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

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 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 metaanalysis 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 crossfunctional 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 nonclinical 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.
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

Work Location Assignment:
Flexible

Work Location Assignment:
Flexible

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