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.Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.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.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.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.May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or respond to questions, as needed.Monitors progress on study activities against agreed upon milestones.Provides statistical programming support as needed.May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities.Maintains well organized, complete, and up-to-date project documentation.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.Proficiency in programming.Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research.Experience across all statistical tasks required to support clinical trials during the lifecycle of the project.Experience with regulatory submissions preferred.Excellent written and verbal communication skills.Ability to read, write, speak, and understand English.Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered. Further, nothing contained herein should be construed to create an employment contract.
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Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status.
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