Overview
Sr/Pr Biostatistician - Immunology & Inflammation
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. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we create a place where everyone feels like they belong.
Responsibilities
* Study lead for 1-2 protocols (late phase, phase 2-3). For phase 3, may support another main statistic
* IRT
* eCRF
* DMC setup
* Study risk management plan (SRMP)
* Prepare SAPs, tables, listings, and figures (tfls/STS); collaborate with the sponsor as required
* Review specifications
* STS (statistical surveillance); review blinded data; participate in 2-3 STS meetings during study life
* Handling intercurrent events
* SAS or R
* May partially program the efficacy
* Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR
* May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications, and input to the clinical study report
* Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high‑quality work; provide independent review of project work
* Creates or reviews programming specifications for analysis datasets, tables, listings, and figures
* Reviews SAS annotated CRFs, database design, and other study documentation to ensure protocol criteria are met and data is captured as required
* Conducts verification and quality control of project deliverables, ensuring output aligns with SAP and specifications
* Implements company objectives and creates alternative solutions to address business and operational challenges
* Serves as biostatistics representative on project teams; prepare for internal meetings and demonstrate respect for others' opinions
* Manages scheduling and time constraints across multiple projects; communicates difficulties with timelines to biostatistics management
* Monitors progress on study activities against milestones and ensures study timelines for project deliverables are met; identify out-of-scope tasks and escalate
* Provides statistical programming support as needed
* May participate in Data Safety Monitoring Board / Data Monitoring Committee activities as an independent non-voting biostatistician
* May lead projects involving integrated analyses, attend regulatory agency meetings, or respond to questions to support the statistical analysis results
* Follows applicable SOPs, work instructions, 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 needed
* Supports business development activities by contributing to proposals, budgets, and sponsor bid defense meetings
* Coaches and mentors other Biostatistics staff
* Performs other work-related duties as assigned
* Minimal travel may be required
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.
http://www.syneoshealth.com
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.
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