Principal Biostatistician (R/Rshiny - EMEA BASED)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point 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.

Company Benefits and Culture

We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. We are continuously building the company we all want to work for and our customers want to work with. By bringing together smart colleagues from around the world, we can shape the future of healthcare, drive impact for customers and set the pace of patient progress.

Job Requirements and Location

Must be located in the UK, Ireland, Poland, Spain, Greece, Hungary, Belgium, Romania, Ukraine, Netherlands, or France. Industry experience as a lead Biostatistician using R or Rshiny is required.

Principal Biostatistician – RShiny Specific

• Sets up and maintains an excellent R‑based computing environment.
• Adds missing features to apps and fixes bugs in existing apps.
• Screens the market for supplied data visualization tools and integrates internal/external apps into our working environment.
• Organizes and performs user trainings and is available for user support on demand.
• Is up to date with the latest technical possibilities available on the global market.
• Excellent R and R‑shiny knowledge and thorough experience in clinical data structures and programming with data.
• Expert in functional and object‑oriented programming.
• Knowledgeable in Javascript/Typescript, HTML, WebGL.
• Experience in CUDA/GPU‑programming, cloud computing, Github, web‑hosting, machine learning.
• Strong communication skills and ability to work both independently and collaboratively, clear in the presentation of complex issues.

Job Responsibilities

• Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for biostatistics associates.
• Conducts training sessions or otherwise trains new hires and enhances the skills of existing personnel.
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.
• Provides independent review of project work produced by other biostatisticians in the department.
• Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well‑presented mock‑up displays for tables, listings, and figures.
• May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required.
• Implements company objectives and creates alternative solutions to address business and operational challenges.
• Acts as the biostatistics representative on project teams, interfaces with other departmental project team representatives.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications.
• May lead complex or multiple projects (e.g. submissions, integrated analyses), attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study‑related activities with biostatistics management, adapts to timeline or priority changes, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
• Identifies out‑of‑scope tasks and escalates to management.
• Provides statistical programming support as needed.
• May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non‑voting biostatistician.
• May serve as a voting statistician on DSMBs and/or DMCs.
• Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up‑to‑date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
• Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Performs other work‑related duties as assigned.
• Minimal travel may be required.

Qualifications

• Previous Rshiny experience is required.
• PhD or MS in Biostatistics, Statistics, Mathematics, or Data Science with a strong emphasis on computing/informatics.
• At least two years of experience as a statistician with significant time spent in the Pharma, Biotech, or similar sector.
• Excellent R and R‑shiny knowledge.
• Thorough experience in clinical data structures and programming with data.
• Expert in functional and object‑oriented programming.
• Knowledgeable in Javascript/Typescript, HTML, WebGL.
• Experience in CUDA/GPU‑programming, cloud computing, Github, web‑hosting, machine learning.
• Strong communication skills and ability to work both independently and collaboratively, with clear presentation of complex issues.
• Team player.
• Fluency in English.

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. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. All terms comply with applicable legislation, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations when appropriate.