Principal Biostatistician (EMEA Only - Medical Affairs)Updated: December 9, 2024
Location: Spain-Europe - ESP-Home-Based (Barcelona)
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.
Job Responsibilities Specific to role:
Support complex analysis for PublicationReviewing abstract, posters, manuscriptsStrong communication, challenge the medical, make good proposal, collaborateBasic programming in SAS and/or R requiredObservational studies (propensity score, causal inference, etc.)
experience beneficialExperience in RWE is acceptableStudy and project planning beneficialExperience in clinical trials would be good to haveExperience in HTA/HEOR – present for additional position if such candidates are identifiedGeneral:
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 enhances 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.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 respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.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.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.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.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 to 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.
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.
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