Overview updated: october 21, 2025 location: mex-remote job id: 25102409 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 puts the customer and the patient at the center of everything we do. We continually strive to simplify and streamline our work to better serve our customers and patients. 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: 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 they belong. Job responsibilities study lead 1-2 protocol (late phase, phase 2-3) for phase 3, may be supporting another main stat irt ecrf dmc set up study risk management plan (srmp) prepare sap, tfls, sts review specs sts (stat surveillance), reviewing blinded data, 2-3 sts meetings during study life recruiting the right patients? Data look okay assess statistical assumptions handling intercurrent events sas or r may partially program the efficacy provide support across all assigned statistical tasks during the lifecycle of the project, from protocol to csr prepare statistical analysis plans (saps), including development of mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required may be responsible for the statistical aspects of the protocol, generation of randomization schedules, publications, and input to the clinical study report coordinate 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 review programming specifications for analysis datasets, tables, listings, and figures review sas annotated crfs, database design, and other study documentation to ensure protocol criteria are met and data is captured as required conduct and participate in verification and quality control of project deliverables implement company objectives and create alternative solutions to address business and operational challenges serve as biostatistics representative on project teams; prepare for internal meetings and contribute ideas with respect for different opinions manage scheduling and time constraints across multiple projects; adapt to timeline changes and communicate difficulties to biostatistics management monitor progress on study activities against milestones and ensure study timelines are met; identify out-of-scope tasks and escalate as needed provide statistical programming support as needed may participate in data safety monitoring board and/or data monitoring committee activities, including charter development may lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions to support results follow applicable sops, work instructions, and regulatory guidelines (e.g., ich) maintain organized, complete, and up-to-date project documentation and verification/quality control documents; ensure inspection readiness collaborate with others and assist with projects to meet business needs support business development activities by contributing to proposals, budgets, and sponsor bid defenses coach and mentor 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 environment. Learn more about syneos health. 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. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: email: jobs@syneoshealth.com at syneos health, we are dedicated to building a diverse, inclusive and authentic workplace. We encourage applications even if past experience doesn’t align perfectly, and we consider transferable skills from previous roles. You may join our talent network to stay connected to additional career opportunities. Discover what our 29,000 employees already know: work here matters everywhere. A career with syneos health means your everyday work improves patients’ lives around the world. A company that you choose should secure a career where you’re supported. Phone: 919 876 9300 fax: 919 876 9360 toll-free: 866 462 7373 j-18808-ljbffr