Sr Prin / Principal Stat Programmer (SDTM+ADAM+TLF/R Programming) - (Job Number: 24004872)

Senior Principal Statistical Programmer / Principal Statistical Programmer

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.

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

• 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 (i.e. DEFINE.XML).
• May lead or support the development of Standard Operating Procedures (SOPs), guidelines, policies, and/or procedures; Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• 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.

What We’re Looking For

• Experience in leading multiple studies.
• Strong experience in SDTM, ADaM, and TFL.
• Experience in R programming/Git Lab preferred.
• Client facing experience preferred.
• 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.

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 .

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.