Syneos Health - Germany

Principal Biostatistician - EMEA

Home-Based, DEU
21 Apr 2021
21 May 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

This position is responsible for leading projects across multiple studies or programs. A Principal Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. This role requires extensive experience with leading projects as well as previous Oncology experience. Full time permanent opportunity within our Full Service department.


•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.

•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.

•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 responds 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. 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).

•Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.QUALIFICATION REQUIREMENTS

•Minimum Master of Science in Statistics or related area

•Extensive experience in clinical trials and ability to lead complex 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.

•Excellent written and verbal communication skills.

•Ability to read, write, speak, and understand English.


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.


"Equal Opportunities Plan. Its objective is to achieve the principle of equality of opportunity in Syneos Health's employment practices ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions."

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