Syneos Health · 4 months ago
Principal Biostatistician (Rshiny - EMEA & US BASED)
United States
Full-time
Remote
Senior Level, Lead/Staff
2+ years expSyneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. The Principal Biostatistician will set up and maintain R-based computing environments, mentor biostatisticians, and oversee the statistical tasks throughout project lifecycles, ensuring high-quality work and timely completion of projects.
BiotechnologyHealth CarePharmaceuticalTherapeutics
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 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 Biostatician 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)
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
Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others
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
Qualification
Required
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
Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Total Self culture
Company
Syneos Health
Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
10001+ employees
H1B Sponsorship
Syneos Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (26)
2023 (49)
2022 (63)
2021 (84)
2020 (63)
Funding
Current Stage
Public CompanyTotal Funding
$524.65M2023-09-28Private Equity
2023-05-10Acquired
2021-03-01Post Ipo Secondary· $524.65M
Leadership Team
Costa Panagos
Chief Executive Officer
Michael Bonello
Executive Vice President and Chief Financial Officer
Recent News
2026-01-09
Company data provided by crunchbase