Principal Biostatistician

Principal Biostatistician (Rshiny - EMEA & US BASED) role at Syneos Health.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. We are united by a Total Self culture, and we welcome diversity of thoughts, backgrounds, cultures and perspectives.

• 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 our Total Self culture – where you can authentically be yourself, united globally, taking care of our people.
• We believe that diversity of thoughts, backgrounds, cultures, and perspectives creates belonging.

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.

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• Submit all CVs in English.
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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. Stays up to date with the latest technical possibilities available on the global market. 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-programing, cloud-computing, Github, web-hosting; strong communication skills; ability to work both independently and collaboratively; clear in presenting complex issues.

• Serve as a statistical department resource, mentor biostatisticians on job skills, and oversee or develop training plans/materials for Biostatistics associates. Conduct training sessions or train new hires to enhance skills.
• Direct activities of other biostatistics personnel on projects to ensure timely completion of high quality work; provide independent review of project work.
• Provide support across all statistical tasks during the lifecycle of a project, from protocol to CSR.
• Prepare or oversee the preparation of SAPs, including mock-ups for tables, listings, and figures. Collaborate with sponsor as required.
• May be responsible as Lead Biostatistician for protocol statistics, randomization schedule, and input to the clinical study report.
• Create or review programming specifications for analysis datasets, tables, listings, and figures.
• Review SAS annotated CRFs, database design, and other study documentation to ensure data supports high quality database and analysis.
• Implement company objectives and create alternative solutions for business/operational challenges.
• Represent biostatistics on project teams; interface with other departmental representatives.
• Prepare for internal meetings, contribute ideas, and respect opinions of others.
• Conduct verification and quality control of project deliverables to ensure alignment with SAP and specifications.
• May lead complex projects (e.g., submissions, integrated analyses) and attend/regulatory agency meetings as needed to support statistical results.
• Manage scheduling and time constraints across multiple projects; communicate progress and adjustments to management.
• Monitor study progress against milestones and ensure timelines are met; identify out-of-scope tasks and escalate as needed.
• Provide statistical programming support as needed.
• May participate in DSMB/DMC activities, including charter development and serving as an independent non-voting statistician; may serve as voting statistician as needed.
• Provide input and follow applicable SOPs, WIs, and regulatory guidelines (e.g., ICH).
• Maintain well-organized, complete project documentation, and verification/quality control documents; ensure inspection readiness.
• Collaborate with others and assist with projects to meet business needs.
• Prepare in advance for internal meetings, contribute ideas, and respect opinions of others.
• Support business development activities by contributing to proposals, budgets, and sponsor bid defense meetings.
• Perform other duties as assigned. Minimal travel may be required.

• Previous Rshiny experience is required.
• PhD or MS in biostatistics, statistics, mathematics or data science with strong computing/informatics emphasis.
• At least two years of experience as statistician in 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; knowledge of Javascript/Typescript, HTML, WebGL; experience in CUDA/GPU-programming, cloud computing, Github, web-hosting; strong communication skills; able to work independently or collaboratively.

Additional information: The Company may assign other tasks at sole discretion. Employment terms are described as per company policy. The information here is intended to comply with applicable laws and regulations. The company is committed to compliance with the Americans with Disabilities Act and reasonable accommodations.

Principal Biostatistician - RShiny Specific: Sets up and maintains an excellent R-based computing environment, adds features to apps, and fixes bugs. Screens the market for data visualization tools, integrates apps, and provides user trainings and support. Knowledge in R, R-shiny, Javascript/Typescript, HTML, WebGL, CUDA/GPU, cloud computing, Github, and web-hosting. Strong communication and ability to work independently or collaboratively.