Principal Biostatistician at Yuxi Global

Perímetro Urbano Medellín, Antioquia, Colombia -

Full Time

Start Date

Immediate

Expiry Date

29 Jan, 26

Salary

0.0

Posted On

31 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biostatistics, Statistical Analysis, SAS Programming, Clinical Trials, Project Management, Statistical Methodology, Communication, Problem-Solving, Collaboration, Training, Mentorship, Good Clinical Practices, Microsoft Office, Statistical Documentation, Regulatory Meetings, Study Design

Industry

IT Services and IT Consulting

Description

Company Description Yuxi Global (powered by Veritas Automata) has been a leading force in empowering Life Sciences companies to achieve their digital goals since 2005. We specialize in providing comprehensive solutions, including turnkey enterprise-grade application development, managed development teams, staff augmentation, and strategic consulting via our Veritas Automata Services Team. With headquarters in the United States and a team of over 150 skilled IT professionals located throughout North and South America, including the United States, Colombia, Mexico, Brazil, and Costa Rica, we are well-positioned to meet the unique requirements of our clients. Having partnered with nearly 300 clients, Yuxi Global has played a crucial role in advancing digital solutions for companies in life sciences. Utilizing cutting-edge technologies such as Microsoft Azure, PowerBI, .Net Custom development, Node.JS, React, and UX/UI design, we deliver impactful solutions that drive business growth and captivate audiences. Job Description We are looking for this role to support biostatistical activities in the analysis of clinical trials, acting as the Statistical Lead and providing statistical guidance and advice on complex statistical methodology applicable to clinical trials. Key Responsibilities: Manage and oversee customer relationships on a project level. Act as the Lead biostatistician and primary biostatistician contact with the sponsor at the project level. Has overall accountability of quality, appropriateness and correctness of biostatistician deliverables. Responsible for biostatistics project management (timelines, scope, budget, resourcing) on a project or program level. Write Statistical Analysis Plans (SAPs) for clinical trials. • Development of SAS programs for study TLFs, based on the study SAP and shells. • Provide training/mentorship to statisticians. Generate randomization schemes. Represent clients at regulatory meetings. Provide guidance on study design and statistical methodology during protocol development. Review statistical output produced by the statistical programming team. Review statistical documentation produced by other statisticians. Review the Clinical Study Report (CSR) for appropriateness of statistical methodology described, results reported and conclusions stated. Follow the appropriate Standard Operating Procedures (SOPs) for all biostatistics-related activities. Ensure that all activities comply with Good Clinical Practices (GCP) standards. Qualifications Qualifications: Master’s degree in statistics or equivalent experience and education. Biostatistician experience required. Skills: Proficient in English. (B2) Excellent communication, problem-solving, and collaboration skills. Proficient in Microsoft Office products. Basic programming knowledge (example SAS, SPSS, or other programming language)

Responsibilities

The Principal Biostatistician will manage customer relationships and act as the lead biostatistician for clinical trial projects. Responsibilities include writing Statistical Analysis Plans, developing SAS programs, and providing guidance on statistical methodology.