Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver – for one another, our customers, and, most importantly, for those in need.Job ResponsibilitiesBiostatistician – Real-World Evidence (RWE) Role Overview We are seeking a biostatistician with strong experience in real-world data (RWD) with observational study design and safety study experience in addition to RWE Safety experience. This role will support evidence generation across multiple therapeutic areas. This role will focus on the design, analysis, and interpretation of observational studies using EMR and claims data to inform: clinical development, HEOR, regulatory strategy, and market access. Key Responsibilities Design and execute real-world evidence (RWE) studies using EMR and claims data; Conducting data specs, SAP and protocol with key research objectivesDevelop and apply robust statistical methodologies, including: causal inference methods (e.g., propensity score methods, weighting, matching; GLM or GLMM, MMRM; survival analysis; random forest); Trial emulation frameworks; External control arm development and borrowing strategiesPerform data analysis using healthcare coding systems (e.g., ICD, NDC)Conduct sample size estimation and power calculations for observational and hybrid study designsCollaborate cross-functionally with stakeholders across: HEOR; Market Access; Regulatory; Clinical DevelopmentTranslate complex analytical results into clear, actionable insights, e.g. powerpoint or study report for decision-makingSupport methodological innovation in RWE, including integration of machine learning approaches where appropriateRequired Qualifications M.S. or Ph.D. in Biostatistics, Statistics, Epidemiology, or related field≥5 years of experience in RWD/RWE analytics (industry or equivalent)Strong experience with EMR and/or claims dataProficiency in healthcare coding systems (e.g., ICD, NDC)Programming expertise in at least one of: SAS, R, or PythonWorking knowledge with SQL logic and OMOP data structuresSolid understanding of: causal inference methods; Observational study design; Sample size and power considerations; Some examples: Independently write cohort definitions in SQL logic; Debug data issues e.g., time zero alignment, exposure gaps; Understand concept mapping (ICD ↔ SNOMED ↔ RxNorm); Translate statistical estimand → censoring rule and data extraction logic.Preferred Qualifications Ph.D. strongly preferredFamiliarity with: Trial emulation methodologies; External control borrowing / hybrid designsBasic machine learning methods applied to RWDDemonstrated ability to work across multiple therapeutic areas (TAs) in a fast-paced environmentStrong communication and stakeholder engagement skillsAdvanced (nice-to-have, not always required) Build reusable cohort pipelinesOptimize queries for large-scale databasesWork across multiple CDMs (OMOP, Sentinel, PCORnet)Core Competencies Analytical rigor and methodological depthCross-functional collaborationAbility to operate with agility across diverse projects and therapeutic areasClear and effective scientific communicationOpen to all US states and Canada. Remote based position.At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.Salary Range:$80,600.00 - $145,000.00The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.Get to know Syneos HealthOver 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.Additional InformationTasks, 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.Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients.We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing.The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role.Why Work HereDiscover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to:Collaborate with passionate problem solversPartner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it.Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration.We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population.We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.
8 days ago