Overview
Principal Biostatistician (Medical Affairs - CAN & Europe) at Syneos Health. Description: Principal Biostatistician (Medical Affairs - CAN & Europe). Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient. We collaborate across Functional Service Provider partnerships or Full-Service environments to deliver therapies and accelerate delivery.
Work location: Canada and Europe. This role is fully aligned with our Medical Affairs practice in CAN & Europe.
Responsibilities
* Provide supports to the clinical study and/or project team on all relevant statistical matters.
* Provide high quality input into the design of the clinical study (including protocol development), the setup and conduct of the study to ensure data are adequately captured and collected to answer the study objectives and support planned statistical analyses.
* Accountable for all statistical deliverables related to the study: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, Statistical Analysis Plan, data surveillance, and statistical analysis results for CSR and its appendices (TLGs and in-text tables).
* Effectively utilize external groups, e.g., CROs or data monitoring committees (DMC).
* Coordinate with the programming team to provide definitions, documentation and review of derived variables, and the quality control plan.
* Perform and/or coordinate with study programmers the production of statistical analyses; review and examine statistical data distributions/properties.
* Oversee execution of the statistical analyses according to the SAP; prepare statistical methods and provide statistical insight into interpretation and discussion of results sections for the CSR and/or publications to ensure statistical integrity in line with internal standards and regulatory guidelines.
* Propose, prepare and perform exploratory data analyses and ad-hoc analyses as relevant for study or project objectives.
* Contribute to define and review deliverables related to Transparency and Disclosure.
* Plan and track study/project activities and timelines.
* Ensure productive collaborations with other functions in the study team, promoting teamwork, quality, operational efficiency, and innovation.
* Note: This position is open to candidates in Canada and Europe only.
Required Education/Experience
* PhD or MS in statistics or related discipline with at least 5 years of pharmaceutical experience.
* Good knowledge of pharmaceutical clinical development, including late phase and/or post-marketing activities.
* Broad knowledge and understanding of advanced statistical concepts and techniques.
* Ability to work in a departmental computing environment; able to perform advanced statistical analyses using SAS and possibly other languages (e.g., R).
* Demonstrated strong interpersonal, communication, and writing skills.
* Experience working in clinical development and interacting with external stakeholders.
Why Syneos Health
We are committed to 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 foster a Total Self culture where you can authentically be yourself. We value diversity of thoughts, backgrounds, cultures, and perspectives to create a sense of belonging.
Company information: Syneos Health has worked with many leading products and sites worldwide. We welcome applicants who want to challenge the status quo in a dynamic environment. http://www.syneoshealth.com
Legal and Compliance
The duties described are not exhaustive. The Company may assign additional tasks at its discretion. This description does not constitute an employment contract, and equivalent experience, skills, or education may be considered. The Company complies with applicable laws, including the EU Equality Directive and the Americans with Disabilities Act where appropriate.
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