Principal Biostatistician (EMEA Only - Medical Affairs)
Updated: January 17, 2025
Location: United Kingdom-Europe - GBR-Home-Based
Job ID: 24006630
Principal Biostatistician (Medical Affairs)
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. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
* 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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
* We are continuously building the company we all want to work for and our customers want to work with. Why? 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.
Job Responsibilities
Specific to role:
* Support complex analysis for publication.
* Reviewing abstracts, posters, manuscripts.
* Strong communication, challenge the medical, make good proposals, collaborate.
* Basic programming in SAS and/or R required.
* Observational studies (propensity score, causal inference, etc.) experience beneficial.
* Experience in RWE is acceptable.
* Study and project planning beneficial.
* Experience in clinical trials would be good to have.
* Experience in HTA/HEOR – present for additional position if such candidates are identified.
General:
• Serve as a statistical department resource, mentor biostatisticians on job skills, and oversee or develop training plans or materials for Biostatistics associates.
• 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 in the department.
• 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-up displays for tables, listings, and figures. Collaborate 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.
• Create or review programming specifications for analysis datasets, tables, listings, and figures.
• Review 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.
• Implement company objectives, and create alternative solutions to address business and operational challenges.
• As biostatistics representative on project teams, interface with other departmental project team representatives.
• Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for opinions of others.
• Conduct and participate 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 respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Manage scheduling and time constraints across multiple projects, set goals based on priorities from management, discuss time estimates for completion of study-related activities with biostatistics management, adapt to timeline or priority changes by reorganizing daily workload, and proactively communicate to biostatistics management any difficulties with meeting these timelines.
• Monitor progress on study activities against agreed-upon milestones and ensure the study timelines for project deliverables are met. Identify out-of-scope tasks and escalate to management.
• Provide 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.
• Provide input and review, and subsequently follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintain well-organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
• Display willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
• Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Perform other work-related duties as assigned.
• Minimal travel may be required.
Qualifications
What we’re looking for
• Graduate degree in biostatistics or related discipline.
• Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies.
• Proficiency in programming.
• Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and effectively communicate statistical concepts.
• Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.
• Experience with regulatory submissions preferred.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.
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.
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. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. 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.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.
Syneos Health is a leading 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. Together we share insights, use the latest technologies and apply advanced business practices to speed
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