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Principal Stat Programmer (Adam, Tlf's , Sdtm)

1+ years
Not Disclosed
10 Nov. 29, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Principal Statistical Programmer

Company: Syneos Health
Location: [Location not specified]


About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success by translating clinical, medical affairs, and commercial insights into actionable outcomes. With 29,000 employees across 110 countries, Syneos Health remains committed to improving patient lives and advancing therapies through innovation, collaboration, and expertise.

"Work Here Matters Everywhere"


Why Syneos Health?

Syneos Health fosters an environment where employees thrive through career development, technical training, peer recognition, and a comprehensive total rewards program. Our Total Self culture unites us globally, focusing on diversity, inclusion, and providing a workplace where everyone can be their authentic selves.


Role Overview

As a Principal Statistical Programmer, you will be responsible for leading programming efforts across multiple projects, ensuring the timely and accurate delivery of statistical analysis outputs. This role involves working with teams to develop and validate statistical programs, contribute to regulatory submissions, and mentor other programmers, with a focus on CDISC Standards and clinical trial processes.


Key Responsibilities

  • Programming Leadership & Development:

    • Develop SAS programs or use other required software to generate statistical outputs such as summary tables, data listings, graphs, and derived datasets, ensuring alignment with the Statistical Analysis Plan (SAP).

    • Lead the programming activities for multiple complex and global projects, coordinating deliverables and managing timelines.

    • Oversee the development of specifications for datasets and outputs, ensuring they meet the highest standards of quality and efficiency.

  • Quality Assurance & Compliance:

    • Conduct validation programming to ensure the accuracy of statistical outputs.

    • Work with other programmers, biostatisticians, and project teams to resolve discrepancies and ensure adherence to ICH guidelines and regulatory standards.

    • Maintain inspection-ready project documentation, including programming code, quality control documentation, and testing results.

    • Ensure CDISC Standards compliance for regulatory submissions, including SDTM and ADaM datasets, and contribute to DEFINE.XML development.

  • Team Collaboration & Mentorship:

    • Act as the lead statistical programmer, directing and mentoring other programming personnel, providing feedback, and fostering skill development.

    • Review project documentation such as the Statistical Analysis Plan, mock shells, and annotated CRFs, offering feedback to reduce inefficiencies and enhance programming accuracy.

    • Participate in sponsor meetings and kickoff meetings as the primary statistical programming representative, ensuring clear communication of deliverables and timelines.

  • Process Improvement & Innovation:

    • Contribute technical expertise to the development of programming tools, macros, and standard operating procedures (SOPs) to increase efficiency and consistency across projects.

    • Stay updated on the latest industry and regulatory standards, including changes to CDISC Standards, and guide the Biostatistics and Statistical Programming departments in their implementation.

    • Participate in industry standards organizations and contribute to the development of new programming methodologies.


Qualifications

Education & Experience:

  • Undergraduate degree in a scientific or statistical discipline, or an equivalent combination of education and demonstrated programming experience.

  • Extensive programming experience in SAS (or other relevant software), particularly in a clinical trial environment, with the ability to lead multiple complex, global projects.

  • Deep knowledge of CDISC Standards (SDTM, ADaM, and related regulatory requirements), with a preference for experience in regulatory submissions.

Skills & Competencies:

  • Expertise in clinical drug development, with a focus on the clinical trial process and regulatory submission requirements.

  • Proven ability to lead teams, mentor junior programmers, and manage multiple concurrent programming deliverables.

  • Excellent written and verbal communication skills, with the ability to explain complex technical concepts to various stakeholders.

  • Strong organizational skills and the ability to work efficiently across multiple projects.

Additional Requirements:

  • Experience in mentoring or training junior team members on CDISC standards and clinical programming best practices.

  • Ability to work collaboratively with cross-functional teams and other departments.

  • Minimal travel may be required for the role.


Why Work with Us?

  • Career Development: Join a company committed to professional growth, providing continuous opportunities for skill advancement and leadership roles.

  • Collaborative Culture: Work alongside industry experts in an inclusive and dynamic environment focused on innovation and excellence.

  • Competitive Benefits: Enjoy a comprehensive benefits package designed to support your health, wellbeing, and financial security.

  • Global Impact: Contribute to life-changing therapies that improve patient outcomes across the globe.


Apply Now to become a key part of Syneos Health and help shape the future of biopharmaceutical research and development.


Syneos Health encourages applicants from diverse backgrounds to apply, even if you don't meet all of the listed qualifications. We value transferable skills and actively seek individuals who challenge the status quo. Join our Talent Network to stay informed about future opportunities.