Programmer Lead for Biopharmaceutical Solutions

2 weeks ago

Dublin, Dublin City, Ireland Syneos Health, Inc. Full time
Key Responsibilities
As a Sr. Statistical Programmer, you will be responsible for:
  • Developing custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications;
    Ensuring that outputs meet quality standards and project requirements;
    Performing validation programming and working with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings;
    Keeping project team members informed of programming progress and issues requiring their attention;
    Following applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH);
    Maintaining well-organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness;
    Negotiating and establishing accurate time estimates for completion of study programming activities with internal team members and statistical programming management;
    Completing project programming activities within timeframe allotted;
    Directing the programming activities of other programming personnel and monitoring progress on programming deliverables;
    Providing feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities;
    Participating in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor;
    Contributing to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process;
    Transferring deliverables;
    Performing other work-related duties as assigned;
    Minimal travel may be required.

    Qualifications

    • Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience;
    • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment;
    • Excellent written and verbal communication skills;
    • Ability to read, write, speak and understand English;
      Knowledge of regulatory guidelines and industry standards (e.g. ICH).

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