Sr Principal R Programmer- PK/PD Expertise Required (NA Based)

Syneos Health, Inc.; New York (NY); Remote; USD 90,000 - 130,000; Full time

Job summary

A global biopharmaceutical solutions organization is seeking a Sr Principal R Programmer to provide statistical programming support primarily using SAS, focusing on complex PK/PD studies. The ideal candidate possesses strong mentoring abilities and extensive experience in clinical trials and data analysis. This remote role requires excellent communication skills and a commitment to quality and compliance in programming activities.

Benefits

Career development opportunities

Supportive management

Diversity and inclusion initiatives

Qualifications

• Extensive programming experience in SAS or other software, preferably in a clinical trial environment.
• Excellent communication, presentation, and interpersonal skills, both written and verbal.
• Ability to read, write, speak, and understand English.

Responsibilities

• Provides statistical programming technical support across Biostatistics functions.
• Mentors other members of the Biometrics Department in programming approaches.
• Maintains project documentation and ensures inspection readiness.

Skills

PK/PD

SAS

Clinical trial experience

Statistical programming

Mentoring

Communication skills

Education

Undergraduate Degree in scientific or statistical discipline

Tools

SAS

Job description

Sr Principal R Programmer- PK/PD Expertise Required (NA Based)

Updated: October 2, 2025
Location: USA-NY-Remote

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. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

• Must be located in Canada or United states
• Must have previous lead CRO experience within R and PK/PD studies.
• Provides statistical programming technical support and expertise across the Biostatistics function and other departments as needed.
• Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
• Proposes and leads the development of process improvements, programming tools and macros for standardization and efficiency, and the development of new concepts, technologies and products to meet emerging customer needs.
• Analyzes information and develops innovative solutions to programming and data analysis challenges across the department.
• Reviews, provides input, and promotes standardization of CRFs, databases, Statistical Analysis Plans and mock shells within a project or therapeutic area, or across a program.
• Mentors other members of the Biometrics Department in the use of traditional, new, and novel approaches in delivering analytics to sponsors and regulatory agencies through the development and presentation of training courses and one on one discussion.
• Understands and enforces compliance with company, regulatory, and industry standards, within and across projects or programs.
• May develop or review specifications and may support any kind of statistical programming activity.
• Negotiates and establishes accurate time estimates for completion of projects with internal team members and statistical programming management, provides regular status updates, and completes projects within agreed upon timeframe.
• Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
• May act as primary customer interface representing the department at client meetings; may present status updates at Senior Management meetings.
• Displays willingness to work with others, holds project team members accountable, and leads projects and initiatives as necessary to meet the needs of the business.
• May provide project oversight to Lead Statistical Programmers across one or more programs.
• Maintains extensive working knowledge of clinical drug development, industry standards, and electronic submission requirements.
• Actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. May contribute to presentations at industry conferences and roundtables.
• When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents.
• May lead or support the development of Standard Operating Procedures (SOPs), guidelines, policies, and/or procedures; Follows applicable SOPs, WIs, and relevant regulatory guidelines.
• Supports business development activities by contributing to proposals, requests for information, budgets, and attending sponsor bid defense meetings
• Performs other work-related duties as assigned.
• Minimal travel may be required.

Qualifications

• PK/PD and R are Required
• Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated technical expertise in programming.
• Participation in publications or presentations in areas relevant to programming or industry standards is preferred.
• Extensive programming experience in SAS or other required software, preferably in a clinical trial environment, as demonstrated by the ability to develop tools or lead multiple complex and/or global projects with teams of statistical programmers; and effectively work across functional lines to accomplish company-wide goals.
• Knowledge and experience in the use of CDISC Standards for regulatory agency requirements.
• Experience in submissions to a regulatory agency preferred.
• Experience in mentoring others in clinical trial process and CDISC Standards.
• Excellent communication, presentation, and interpersonal skills, both written and verbal, with an ability to inform, influence, convince, and persuade.
• Ability to read, write, speak, and understand English.

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 and will not be discriminated against.