Principal Statistical Programmer
Company: Syneos Health
Location: Global
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. With our unique approach to clinical development, medical affairs, and commercial insights, we aim to deliver effective solutions to address modern market challenges.
"Work Here Matters Everywhere"
Why Syneos Health?
At Syneos Health, we foster a culture that emphasizes career development, engagement, and continuous growth. We are passionate about helping our people develop through training, recognition, and support. Our Total Self culture allows employees to bring their authentic selves to work, creating an inclusive and diverse environment where everyone belongs.
We are committed to building a company that our employees want to work for and our customers want to partner with.
Role Overview
As a Principal Statistical Programmer, you will utilize SAS and other software to develop custom programming codes that generate summary tables, data listings, graphs, and derived datasets for clinical trials. You will lead programming activities, ensuring that all deliverables meet high-quality standards, regulatory requirements, and project timelines.
Key Responsibilities
Programming & Data Analysis:
Develop custom programming codes in SAS to generate statistical outputs (summary tables, listings, graphs, derived datasets) based on the statistical analysis plan.
Ensure programming outputs meet quality standards, project specifications, and regulatory requirements.
Collaboration & Issue Resolution:
Work closely with biostatisticians, programmers, and project teams to validate data and resolve discrepancies.
Communicate programming progress and issues effectively to project stakeholders.
Participate in meetings, such as sponsor meetings and bid defense meetings, as the lead statistical programmer.
Project Leadership & Mentorship:
Act as the lead statistical programmer for complex or global projects, providing guidance and oversight to other programming personnel.
Manage project timelines, set goals, and adapt workflows to meet shifting priorities.
Mentor junior programmers, providing training and feedback to ensure high-quality deliverables.
Documentation & Compliance:
Maintain comprehensive documentation of programming tasks, ensuring readiness for audits or inspections.
Follow relevant regulatory guidelines (e.g., ICH), SOPs, and work instructions throughout the programming process.
Conduct internal reviews and ensure compliance with CDISC standards, such as SDTM, ADaM, and other regulatory submission requirements.
Process Improvement & Innovation:
Contribute to the development of standard operating procedures, tools, and macros to improve programming efficiency.
Stay current on industry trends and regulatory changes, ensuring compliance with evolving standards.
Client & Sponsor Relations:
Act as the statistical programming representative in sponsor meetings.
Provide subject matter expertise on regulatory and submission standards, including CDISC, DEFINE.XML, and other requirements.
Qualifications
Education & Experience:
Undergraduate degree in a scientific or statistical discipline, or equivalent combination of education and demonstrated programming experience.
Extensive SAS programming experience in a clinical trial environment, with a track record of leading complex global projects.
Strong knowledge and experience with CDISC Standards (e.g., SDTM, ADaM) and regulatory submissions.
Technical Skills:
Proficient in SAS programming, with a deep understanding of statistical methodologies and clinical data analysis.
Experience in regulatory submissions and familiarity with industry standards like CDISC, SDTM, and ADaM.
Experience with programming tools and macros for standardization and efficiency is a plus.
Soft Skills:
Excellent communication skills, both written and verbal.
Leadership experience, with the ability to mentor and guide teams.
Strong problem-solving skills with an ability to manage multiple priorities and meet deadlines.
Other Requirements:
Ability to work effectively in a team environment and adapt to changing project needs.
Minimal travel required.
Why Work with Us?
Career Growth: Syneos Health offers a clear path for career progression and provides opportunities to mentor and grow within the organization.
Impact: Lead statistical programming initiatives that play a pivotal role in advancing clinical trials and regulatory submissions.
Inclusive Environment: Join a team that celebrates diversity and fosters a collaborative work culture.
Comprehensive Benefits: Competitive salary, health benefits, 401k, flexible PTO, and more.
Apply Now to join Syneos Health and be part of a team that is shaping the future of healthcare.
Syneos Health is dedicated to creating an inclusive and authentic workplace. If your background doesn’t perfectly align with the qualifications listed, we encourage you to apply anyway and join our Talent Network for future opportunities.
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