Overview
Principal Biostatistician (RShiny - EMEA & US BASED) – Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient in everything we do. We collaborate with passionate problem solvers to help customers achieve their goals in either Functional Service Provider partnerships or Full-Service environments.
Responsibilities
- Serve as a statistical department resource, mentor biostatisticians on job skills, and oversee or develop training plans or materials for Biostatistics associates. Conduct training sessions or train new hires to enhance skills.
- Direct the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work. Provide independent review of project work produced by other biostatisticians.
- Provide support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
- Prepare or oversee the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-ups for tables, listings, and figures;
collaborate with sponsor as required.
May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of 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 protocol criteria are met and data capture supports the planned analyses.Implement company objectives and develop alternative solutions to address business and operational challenges.Act as biostatistics representative on project teams, interfacing with other departmental representatives.Prepare in advance for internal meetings, contribute ideas, and respect differing opinions.Conduct verification and quality control of project deliverables to ensure alignment with SAP and specifications.May lead complex or multiple projects (e.G., submissions, integrated analyses) and attend regulatory agency meetings or respond to questions to support statistical analyses for the sponsor.Manage scheduling and time constraints across multiple projects, set goals, discuss time estimates, adapt to changes, and communicate progress to management.Monitor progress against milestones and ensure study timelines for deliverables;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 may serve as an independent non-voting statistician or voting statistician as required.Provide input and follow applicable SOPs, WIs, and regulatory guidelines (e.G., ICH).Maintain organized, complete, and up-to-date project documentation and verification / quality control programs to ensure inspection readiness.Collaborate with others and assist with projects and initiatives to meet business needs.Support business development activities by contributing to proposals, budgets, and sponsor bid defense meetings.Perform other duties as assigned;minimal travel may be required.
Qualifications
Previous RShiny experience is required for this role.PhD or MS in biostatistics, statistics, mathematics or data science with a strong computing / informatics emphasis.At least two years of experience as a 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.Knowledgeable in Javascript / Typescript, HTML, WebGL;experience in CUDA / GPU programming, cloud computing, GitHub, and web hosting.
Strong communication skills and the ability to work independently and collaboratively;clear in presenting complex issues;team player.
Fluency in English.About Syneos Health
We are committed to developing our people through career development and progression, supportive line management, training, peer recognition, and a total rewards program. We value diversity of thought and backgrounds and strive to create a sense of belonging for all employees.
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