Pr Statistical Programmer

Overview

Lead statistical programming work on clinical trial deliverables, using SAS or other required software to produce outputs, datasets and CDISC-compliant submissions for Syneos Health clinical solutions projects.

What you'll do

• Use 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.
• Ensure outputs meet quality standards and project requirements.
• Perform validation programming and work with other programmers, biostatisticians and project team members to resolve discrepancies or findings.
• Keep project team members informed of programming progress and issues requiring their attention.
• Follow applicable SOPs, WIs and relevant regulatory guidelines (e.g. ICH).
• Maintain well organized, complete and up-to-date project documentation, testing, verification/quality control documents and programs, ensuring inspection readiness.
• Manage scheduling and time constraints across multiple projects, set goals based on management priorities, and adapt to timeline or priority changes.
• Develop specifications for datasets and outputs of any complexity according to statistical or sponsor requirements.
• Conduct effective internal meetings, distribute relevant information in advance, ensure minutes are promptly and accurately distributed, and follow action items through to completion.
• Be accountable for on-time delivery across concurrent programming deliverables; negotiate programming timelines and provide risk mitigation plans.
• Proactively inform management of deliverable status and significant project issues, including planned resolutions.
• Act as the lead statistical programmer, directing the programming activities of other programming personnel and monitoring progress on deliverables.
• Review project documentation such as the Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs and SAS database design, and provide feedback.
• Participate in sponsor meetings, kickoff meetings and bid defense meetings as statistical programming representative, as required by the sponsor.
• Contribute to mentoring programming personnel through developing training courses, presenting training materials, reviewing work and guiding new associates.
• Maintain working knowledge of clinical drug development, industry standards and electronic submission requirements; serve as technical expert resource for complex programming questions.
• Work with biostatistics and statistical programming personnel to establish SOPs, guidelines, policies and/or procedures.
• Contribute technical expertise to the development of programming tools and macros for standardization and efficiency.
• As a CDISC and regulatory subject matter expert, provide guidance and training on the appropriate use of CDISC Standards.
• Perform compliance reviews of CDISC deliverables including SDTM and ADaM specifications and datasets, and regulatory required documents (e.g. DEFINE.XML).
• As a CDISC and regulatory subject matter expert, actively participate in industry standards organizations and provide regular updates to the Biometrics Department on upcoming changes to those standards.
• Transfer deliverables and perform other work-related duties as assigned.

What you'll need

• Undergraduate degree, in a scientific or statistical discipline; or an equivalent combination of education and demonstrated programming experience in lieu of a degree.
• Extensive programming experience in SAS or other required software, in a clinical trial environment, demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers.
• Knowledge and experience in the use of CDISC Standards for regulatory agency requirements.
• Excellent written and verbal communication skills.
• Ability to read, write, speak and understand English.

Nice to have

• Undergraduate degree preferably in a scientific or statistical discipline.
• Experience in submissions to a regulatory agency.
• Experience in mentoring others in the clinical trial process and CDISC Standards.

Details

• Location: India, remote.
• Minimal travel may be required.