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    Principal Stat Programmer (R Prog + Sas + Sql)

    Syneos Health
    2+ years
    Not Disclosed
    Remote
    10 March 3, 2025
    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 Stat Programmer (R Prog + SAS + SQL)
    Updated: February 27, 2025
    Location: India-Asia Pacific - IND-Home-Based
    Job ID: 25001818

    Description

    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 centers around the customer and patient, ensuring streamlined and simplified work processes.

    Whether joining us in a Functional Service Provider partnership or a Full-Service environment, you will collaborate with passionate problem solvers, innovating as a team to help customers achieve their goals. Our agile and driven approach accelerates the delivery of therapies, as we are committed to changing lives.

    Discover what our 29,000 employees across 110 countries already know:
    WORK HERE MATTERS EVERYWHERE

    Why Syneos Health

    • Passionate about career development and progression.
    • Supportive and engaged line management.
    • Technical and therapeutic area training.
    • Peer recognition and total rewards programs.
    • Commitment to our Total Self Culture, fostering an inclusive workplace.
    • Diversity of thought, backgrounds, cultures, and perspectives.

    Job Responsibilities

    • Develops custom programming code using SAS, R, or SQL to generate summary tables, data listings, graphs, and derived datasets.
    • Ensures outputs meet quality standards and project requirements.
    • Performs validation programming and resolves discrepancies.
    • Maintains well-organized project documentation ensuring inspection readiness.
    • Manages scheduling and time constraints across multiple projects.
    • Develops specifications for datasets and outputs according to statistical or sponsor requirements.
    • Conducts effective internal meetings, ensuring documentation and follow-ups.
    • Displays willingness to assist with projects and business needs.
    • Ensures on-time delivery of concurrent programming deliverables.
    • Acts as the Lead Statistical Programmer, directing programming activities and monitoring progress.
    • Reviews project documentation (e.g., Statistical Analysis Plan, mock shells, annotated CRFs, etc.).
    • Participates in sponsor meetings and bid defense meetings.
    • Contributes to mentoring programming personnel through training and guidance.
    • Maintains knowledge of clinical drug development, industry standards, and regulatory requirements.
    • Establishes Standard Operating Procedures (SOPs) and contributes to programming tools development.
    • Serves as a subject matter expert for CDISC Standards and regulatory compliance.
    • Performs compliance reviews of CDISC deliverables (e.g., SDTM, ADaM, DEFINE.XML).
    • Participates in industry standards organizations and updates Biometrics teams on regulatory changes.
    • Transfers deliverables and performs additional tasks as assigned.
    • Minimal travel may be required.

    Qualifications

    • Undergraduate degree in a scientific or statistical discipline or equivalent experience.
    • Extensive programming experience in SAS, R, or SQL, preferably in a clinical trial environment.
    • Experience levels:
      • Statistical Programmer II: 2-4 years.
      • Senior Statistical Programmer: 5-8 years.
      • Principal Statistical Programmer: 8+ years.
    • Expertise in R Programming, Anonymization of Clinical Datasets preferred.
    • Experience in GitHub/GitLab is preferred.
    • Theoretical knowledge and hands-on experience in SDTM/ADaM will be advantageous.
    • Excellent written and verbal communication skills.
    • Strong R (R Studio) and SQL programming skills for data redaction.
    • Knowledge of Python may be beneficial for reviewing code/outputs.
    • Strong attention to detail for reviewing clinical data pre- and post-processing.
    • Knowledge of the drug development process (Phase I-IV) and regulatory requirements.
    • Experience in study lead roles, capable of managing multiple studies.

    Get to Know Syneos Health

    Over the past five years, we have worked with:

    • 94% of all Novel FDA Approved Drugs.
    • 95% of EMA Authorized Products.
    • 200+ studies across 73,000 sites and 675,000+ trial patients.

    No matter what your role is, you will take the initiative and challenge the status quo in a highly competitive environment. Learn more about Syneos Health.

    Additional Information

    • Tasks, duties, and responsibilities 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 may be considered for qualification differences.
    • Compliance with the Americans with Disabilities Act (ADA), including reasonable accommodations.
    • Full compliance with EU Equality Directive in recruitment and employment.

     

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