Principal Biostatistician, Sr Biostatistician – R/Rshiny
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Job Description
Principal Biostatistician role supporting drug development projects at Syneos Health. Involved in clinical data analysis, training, and statistical planning across EMEA.
Responsibilities:
- Sets up and maintains 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.
- 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.
- Collaborates with sponsor, if 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.
- 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.
- Implements company objectives, and creates alternative solutions to address business and operational challenges.
- As biostatistics representative on project teams, interfaces with other departmental project team representatives preparing in advance for internal meetings, contributing ideas, and demonstrating 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), 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.
- 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).
Requirements:
- Previous Rshiny experience is required for this role.
- 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
- 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 and ability to work both, independently and collaboratively, clear in the presentation of complex issues.
- Team player.
- Fluency in English.
Benefits:
- 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.
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