Biometrics Analyst
サイネオス・ヘルス
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Principal Biostatistician (Rshiny - EMEA & US BASED)
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 brings the customer and the patient to the center of everything that we do. 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 accelerate the delivery of therapies, because we are passionate to change lives.
technical and therapeutic area training; We are continuously building the company we all want to work for and our customers want to work with. Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Please submit all CVs in English
Principal Biostatistician - RShiny Specific:
screens the market for supplied data visualization tools and integrates internal/external apps into our working environment. Is 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/ Machine Learning. 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 enhance 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. 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 to support a high quality database and the planned analysis.
As biostatistics representative on project teams, interfaces with other departmental project team representatives
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), and attend regulatory agency meetings or responds 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 by reorganizing daily workload, 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. 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. 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.
Minimal travel may be required.
PhD or MS in biostatistics, statistics, mathematics or data scientist with a strong emphasis on computing/informatics.
At least two years of experience as statistician with significant time spent in the Pharma, Biotech, or similar sector
- 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
- Fluency in English
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.
Further, nothing contained herein should be construed to create an employment contract. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Principal Biostatistician - RShiny Specific: Sets up and maintains excellent R-based computing environment. screens the market for supplied data visualization tools and integrates internal/external apps into our working environment. Is 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.
$177k - $234.4k per year
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