Real World Biostatistician

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.

Discover what your 25,000 future colleagues 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 building an inclusive culture – where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.

Job Responsibilities

We are seeking a biostatistician with strong experience in real-world data (RWD) with observational study design and safety study experience in addition to RWA CMH 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 (RWA) studies using EMR and claims data; Conducting data specs, SAP and protocol with key research objectives.
• Develop 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 strategies
• Perform data analysis using healthcare coding systems (e.g., ICD, NDC).
• Conduct sample size estimation and power calculations for observational and hybrid study designs.
• Collaborate cross-functionally with stakeholders across: HEOR, Market Access, Regulatory, Clinical Development.
• Translate complex analytical results into clear, actionable insights, e.g. PowerPoint or study report for decision-making.
• Support methodological innovation in RWE, including integration of machine learning approaches where appropriate.

Required Qualifications

• M.S. or Ph.D. in Biostatistics, Statistics, Epidemiology, or related field.
• 5 years of experience in RWA/RWD analytics (industry or equivalent).
• Strong experience with EMR and/or claims data.
• Proficiency in healthcare coding systems (e.g., ICD, NDC).
• Programming expertise in at least one of: SAS, R, or Python.
• Working knowledge with SQL logic and OMOP data structures.
• Solid understanding of causal inference methods, observational study design, sample size and power considerations.

Preferred Qualifications

• Ph.D. strongly preferred.
• Experience in one or more therapeutic areas: Diabetes, Cardiovascular disease, Metabolic disorders.
• Familiarity with trial emulation methodologies, external control borrowing / hybrid designs, basic machine learning methods applied to RWD.
• Demonstrated ability to work across multiple therapeutic areas (TAs) in a fast-paced environment.
• Strong communication and stakeholder engagement skills.

Core Competencies

• Analytical rigor and methodological depth.
• Cross-functional collaboration.
• Ability to operate with agility across diverse projects and therapeutic areas.
• Clear and effective scientific communication.

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.