Principal Biostatistician - Biomarker (EMEA Remote)

Overview

Principal Biostatistician - Biomarker (EMEA Remote). Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Responsibilities

• Collaborates with representatives from other functions to plan, execute and analyze all biomarker aspects (including genomics) of clinical studies or biomarker studies in the role of the biomarker statistician and assumes the role of project biomarker statistician under guidance of an experienced statistician.
• Develops the Biomarker Evaluation Plan for the study as appropriate, ensuring overall consistency within and between projects.
• Provides statistical input in clinical development discussions, and usage of AI and ML approaches.
• Facilitates the overall organization and coordination of statistical activities regarding biomarker research and development activities for specific studies and projects.
• Conducts and designs advanced data analysis for genomics and biomarker statistics, including statistical programming, and designs complex analysis algorithms.
• Experience with RNA, Olink and other biomarker data handling experience.
• Assumes responsibility for the production and accuracy of the Biomarker Evaluation Report with respect to statistical deliverables and interpretation of the results.
• Works independently on routine and complex statistical questions, modeling and tasks.
• Develops and implements standard processes for the analysis of routine (parts of) biomarker assessments.

Qualifications

• PhD or MSc in Biostatistics, Statistics or Mathematics, or related field.
• Strong communication and interpersonal skills.
• Ability to work independently as well as collaboratively, as required.
• Minimal supervision required.
• Usage of AI and ML approaches.
• Previous experience in independently leading biomarker studies is mandatory.
• Previous clinical trial experience; industry experience is preferred.
• Strong knowledge on Biomarker evaluation, esp. in immunology and infections, type I diabetes, relevant parameters and underlying biology.
• Good knowledge of statistical programming languages including R (Bioconductor package and other relevant R packages for genetic data) and Python.
• Analysis of high-dimensional data.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. The Company will determine what constitutes as equivalent to the qualifications described above. Nothing herein should be construed to create an employment contract. The Company is committed to compliance with applicable laws and equal opportunity employment practices.

Summary

• Hiring in select Europe countries only. Candidates must require no VISA sponsorship. This position is responsible for leading projects across multiple studies or programs. A Senior Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. This project will focus on Biomarker data.