Biostatistician PhD - Home based

Emmes Services Pvt. Ltd, ("Emmes") is searching for Biostatistician in Clinical Research located in our Bangalore office or home based. Emmes provides flexibility for office location preference, dependent upon position.

EMMES Services Pvt. Ltd, Bangalore, a fully owned subsidiary of The Emmes Company, LLC. Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

A Biostatistician assists on all activities related to the design and development of study protocols, conducting statistical analysis and reporting study outcomes of clinical trials in accordance to the project requirements and with the help of senior members of the team.

Responsibilities

• Helps senior members in the preparation of study protocols, randomization plans, generation of randomization schedule etc.
• Conducts statistical analysis as per SAP, completes programming activities, identifies issues in the clinical study and brings them to the attention of the senior members of the team. (under supervision)
• Performs Quality Control (QC) of own work independently and Quality Control (QC) of other people's work under supervision; Executes assigned tasks with high quality, integrity
• Provides accurate, effective and timely communication of clinical study and defects to senior members of the team.
• Assists in the documentation of clinical study report / manuscript through statistical interpretation of study results.
• Works effectively and collaboratively within biostatistics team

Experience

• Requires a PhD degree Biostatistics, Statistics, or Epidemiology with 2 to 3 years of experience
• Competent in SAS programming language and/or R.
• Good understanding of basic design of experiments and classical inference methodologies
• Expertise in statistical methods and its applications in Clinical Research
• Expertise in GCP principles and other regulatory standards in Clinical Research OR Working knowledge of Good Practice (GxP), International Council for Harmonization (ICH) requirements, internal processes and external regulations that govern drug development
• Good Computational Skills and Proficiency in statistical applications (SAS, R)
• Coordinates & communicates with the internal functional project team on client deliverables

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