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Job Description

Principal Biostatistician

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.

Job Summary

Apply a high level of technical expertise to help guide and develop the more junior biostatistics staff members. Serve as a lead statistician on clinical studies and provide senior level peer review of work being accomplished by other biostatisticians in the department. Maintain the statistical and analytical integrity of clinical trials analyzed by SDC. Actively participate in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Support business development and project management with strategic planning, proposals, pricing, and timeline planning.

Primary Responsibilities

Serve as an internal consultant for biostatistics analysis tools and methods
Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support
Actively support business development in capabilities presentations to prospective and current clients
Effectively manage assigned clinical study budgets for biostatistics analysis support
Develop, coach and mentor junior biostatistics department personnel
Act as the lead statistician on clinical research projects and help with SAS programming
Provide statistical expertise for study design of clinical trial protocols
Write statistical methods section of the study protocol, as needed
Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed
Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP)
Program summary tables, data listings and graphical representations of clinical trials data
Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
Prepare/review key sections of clinical study reports and various regulatory documents
Perform statistical QC of all department outputs including analyses and clinical study reports
Provide statistical support to answer questions from external clients (such as FDA, Investigators)
Contribute to the development, maintenance, and training of standard operating procedures (SOPs)
Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed
Manage biostatistics timelines, budgets, and client expectations
Adhere to all aspects of the Statistics & Data Corporation s quality system
Comply with Statistics & Data Corporation s data integrity & business ethics requirements
Perform other related duties incidental to the work described herein
Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

Effective leadership, budget forecast and implementation skills
Excellent analytical skills, with the ability to process scientific and medical data
Able to work independen

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Statistics & Data Corporation (SDC)
Statistics & Data Corporation (SDC)

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