Senior/Principal Biostatistician

Syneos Health group; Greater London; On-site; GBP 60,000 - GBP 80,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Sr/Pr Biostatistician to lead statistical tasks for clinical trials focusing on Immunology & Inflammation in Europe and LATAM. The ideal candidate will have expertise in statistical programming, experience in managing study design, and a strong analytical background. This role involves preparing statistical analysis plans, coordinating project activities, and ensuring data quality throughout the lifecycle of the study. Opportunities for professional development and collaboration with a dedicated team await in a dynamic workplace.

Benefits

Competitive salary

Professional development opportunities

Diverse team environment

Qualifications

• Experience in biostatistics and statistical programming.
• Ability to manage multiple projects and timelines.
• Familiarity with clinical trial processes and regulations.

Responsibilities

• Lead study design and statistical analysis for clinical trials.
• Prepare statistical analysis plans and review specifications.
• Coordinate activities of biostatistics staff across projects.

Skills

Statistical programming (SAS or R)

Study risk management

Statistical analysis planning

Data quality control

Team coordination

Education

Advanced degree in statistics or related field

Tools

SAS

R

Job description

Overview

Description Sr/Pr Biostatistician - Immunology & Inflammation (Europe and LATAM ONLY)

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 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.

WORK HERE MATTERS EVERYWHERE

Responsibilities

• This position is open to Europe and LATAM Only
• Must be eligible to work with no sponsorship needs from company
• Study lead 1-2 protocol (late phase, phase 2-3)
• For phase 3, may be supporting another main stat
• IRT
• eCRF
• DMC set up
• Study risk management plan (SRMP)
• Prepare SAP, tfls, STS
• Review specs
• STS (statistical surveillance), reviewing blinded data, 2-3 STS meetings during study life
• Recruiting the right patients?
• Data look okay
• Assess statistical assumptions
• Handling intercurrent events
• SAS or R
• May partially program the efficacy
• Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required
• May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report
• Coordinates the activities of other biostatistics and statistical programming 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
• 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
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications
• Implements company objectives, and create alternative solutions to address business and operational challenges
• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from 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 and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician
• May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor
• 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
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings
• Coaches and mentors other Biostatistics staff
• Performs other work-related duties as assigned
• Minimal travel may be required

 Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.

 Get to know Syneos Health

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.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. 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.