ClinChoice - Principal Statistical Programmer/Analyst Consultant

United States1w ago

In Office Principal NA Medical Devices Pharmaceuticals QA Analyst Programmer CRO Close Documentation

Requirements

• Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience. • Need to have Oncology TA experience. • Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology. • Good understanding of the clinical drug development process. • Strong communication skills and coordination skills. • Current knowledge of technical and regulatory requirements relevant for the role • Ability to proactively manage concurrent activities within a project • Proficient ability to influence relevant stakeholders on programming-related items • The Application Process • Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. • Who will you be working for? • ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. • Our Company Ethos • Our Company Ethos • Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

Responsibilities

• The Principal Statistical Programmer Consultant is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks • Principal Statistical Programmer Consultant • Responsible for supporting the Programming deliveries of a clinical study or project. • Implements statistical programming aspects of the protocol and the clinical development program. • Ensures high quality is built into own deliverables and the quality delivered by other programmers. • Programs independently with high efficiency and quality. • Writes and/or implements specifications and oversees completeness of relevant documentation. • Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function. • Ensures compliance with standards and automation usage. • Plans and support team activities and tasks. • Communicates and escalates risks within the assigned studies and/or projects. • Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.