Quanticate UK - Head Office

Senior Statistical Programmer I

IN-KA-Bangalore
1 month ago
ID
2017-1658
# of Openings
1
Category
Programming

Overview

Multi-discipline role, with focus on delivering:

 

  • Project leadership of assigned projects and/or
  • Line management of assigned personnel and/or
  • Technical expertise and leadership in support of Programming deliveries and training development of Programming personnel.
  • Provide project, technical, or line management support in the preparation, and review of high quality programming deliverables and documentation, as well as the processes and standards required, to both colleagues and clients.
  • Provide high-quality, timely support that conforms to current Quanticate and client-specific standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.

Responsibilities

  • Deliver excellent customer care in support of genuine value and a great customer experience.
  • Comprehensive knowledge of clinical and pharmaceutical drug development and associated ICH/GCP guidelines.
  • Excellent knowledge of pharmaceutical industry standards.
  • Comprehensive understanding of current Quanticate, and client-specific standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
  • Maintain up-to-date knowledge of the external regulatory environment relating to programming, including ICH/GCP requirements, and provide advice and educate colleagues (and clients) on changes to regulatory requirements and/or other guidelines relating to programming.
  • Provide high quality deliverables and appropriate communication within expected timelines and budget.
  • Provide mentoring, as required.
  • Ability to lead teams, as required.
  • Ability to work with different functions, and across sites as required
  • Ability to review and provide comments on clinical documents, e.g. protocol, CRF and SAP.
  • Ability to perform Peer Review and Final Inspection.
  • Ability to represent the company at external conferences and forums, from a clinical programming perspective.
  • Participate in meetings such as recruitment, business development and audits from a clinical programming perspective.
  • Perform other reasonable tasks as requested by management.
  • Follow appropriate Project Management procedures.
  • Advanced programming experience covering activities from study set-up to final reporting.

Qualifications

  • Qualified to minimum MSc level in statistics
  • Relevant experience within the pharmaceutical or medical sector is desirable but not essential
  • Good PC skills including working knowledge of Microsoft Office
  • Experience using SAS and other statistical software is desirable
  • Good written and oral communication skills
  • Good organisational skills
  • Good analytical and problem solving skills
  • Strong interpersonal skills

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