Sr. Biostatistician_Clinpharm

Syneos Health; Indiana (PA); On-site; USD 110,000 - 170,000; Full time

Job summary

Syneos Health in the United States seeks Senior Biostatistician (5–8 years) to support statistical activities across drug development. You will review SAPs, define analysis datasets, and contribute to study design and execution.

You will work with SDTM/ADaM, PK/PD analyses, CSR reviews, and TFL validation, applying SAS and collaborating with programming teams. This role offers opportunities to impact multiple programs within a global organization.

Qualifications

• Experience applying statistical methods in drug development.
• Ability to review and interpret SAPs in line with protocols and regulations.
• Strong collaboration with cross-functional teams in late-stage research.

Responsibilities

• Review SAPs in alignment with protocols and regulatory requirements.
• Develop mock shells, define analysis datasets, and support randomization activities.
• Perform protocol reviews and contribute statistical inputs during study design and execution.
• Review CSRs and ensure accuracy and consistency of statistical outputs.
• Support Phase I studies including PK/PD analyses, biomarker evaluations, and clinical pharmacology assessments (Phase 1A, 1B, and 2A).
• Validate Tables, Listings, and Figures (TFLs) and ensure compliance with quality standards.
• Work with CDISC standards (SDTM/ADaM) and collaborate with statistical programming teams.
• Apply SAS for statistical analyses and data review activities.

Skills

SAS

Statistical analyses

Data interpretation

Tools

CDISC SDTM/ADaM

Job description

Description

Sr. Biostatistician_Clinpharm

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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Senior Biostatistician (5–8 Years)

Key Responsibilities

• Review Statistical Analysis Plans (SAPs) in alignment with protocols and regulatory requirements.
• Develop mock shells, define analysis datasets, and support randomization activities.
• Perform protocol reviews and contribute statistical inputs during study design and execution.
• Review Clinical Study Reports (CSRs) and ensure accuracy and consistency of statistical outputs.
• Support Phase I studies including PK/PD analyses, biomarker evaluations, and clinical pharmacology assessments (Phase 1A, 1B, and 2A).
• Validate Tables, Listings, and Figures (TFLs) and ensure compliance with quality standards.
• Work with CDISC standards (SDTM/ADaM) and collaborate with statistical programming teams.
• Apply SAS for statistical analyses and data review activities.

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.