Associate Statistical Programmer

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• Bengaluru, India
• Biometrics/Biostatistics
• No
• Regular Full-Time
• 2893
  
  

Emmes Global

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Overview

Job Description

Associate Statistical Programmer

India Bengaluru

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Associate Statistical Programmer provides statistical programming support for clinical projects,

utilizing SAS for programming and validation. Key responsibilities include understanding of

regulatory compliance and efficient coding practices, staying current with statistical programming

techniques, and communicating project updates to management while performing assigned duties.

Responsibilities

• Provides statistical programming support for one or more clinical research study projects orstudy teams.
• Provides routine statistical programming support and validation with SAS (Base and Macros).
• Ensures that sound methodologies are adopted by acquiring knowledge of programming techniques required for clinical trials research which involve either CDISC standards and analysis data sets or production of standard and custom tables listings and figures.
• Provides key deliverables based on acquired knowledge of regulatory requirements for clinical research E-submissions and/or study requirements for Sponsor, Regulatory,
• Investigator or Safety review meetings.
• Reads programming documentation and annotations including specifications, adhering to relevant Standard Operating Procedures.
• Writes well-documented, efficient and high-quality code, conducts code review and programming validation as needed.
• Acquires knowledge of current statistical programming techniques to ensure the adoption of sound methodologies.
  
  

Provides project updates to appropriate project management or department management staff.

Qualifications

• A bachelors degree, scientific discipline preferred.
• Understanding of GCP principles and other regulatory standards (e.g. FDA, EMA, and IC guidance and recommendations) in Clinical Research.
• Good analytical skills with the ability to process scientific and medical data.
• Ability to follow task assignments and priorities.
• Ability to work independently as well as in a team environment.
• Ability to prioritize and problem-solve.
• Ability articulate programming and technical concepts through written and oral communication.
• Strong communication, interpersonal and organization skills.
• Self-motivated, proactive and detail oriented.
• Strong statistical programming skills in SAS, familiarity with R, Python or other relevant statistical software is considered beneficial.
  
  

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