[Hiring] Statistical Programmer @Syneos Health Careers

Role Description

Pr Statistical Programmer (ADAM, TLF, SDTM)

• Uses 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.
• Works to ensure that outputs meet quality standards and project requirements.
• Performs validation programming and collaborates with other programmers, biostatisticians, and project team members to resolve discrepancies or findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well-organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes.
• Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements.
• Anticipates and addresses potential programming issues, establishes the basis for efficient programming, and accurately defines all variables.
• Conducts effective internal meetings, distributes relevant information in advance, ensures minutes are accurately distributed, and follows action items through to completion.
• Displays willingness to work with others and assist with projects and initiatives as necessary.
• Accountable for on-time delivery across concurrent programming deliverables.
• Negotiates programming timelines and provides risk mitigation plans for projects or programs.
• Acts as the lead statistical programmer, directing the programming activities of other personnel and monitoring progress.
• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design.
• Provides feedback to project team members to reduce inefficiencies in programming activities.
• Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative.
• Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, and providing feedback.
• Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements.
• Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs).
• Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.
• Serves as a technical subject matter expert for CDISC and other industry and regulatory requirements.
• Performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications.
• Actively participates in industry standards organizations and provides updates to the Biometrics Department.
• Transfers deliverables and performs other work-related duties as assigned.
• Minimal travel may be required.

Qualifications

• 8+ years of experience in Clinical SAS Programming.
• Strong expertise in Base SAS/SAS Macros, SDTM, ADAM & TLF programming, and specs creation.
• Hands-on experience with both Safety & Efficacy data.
• Preferred experience in Oncology therapeutic areas.
• Must have ISS/ISE experience and R programming.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.
• Immediate joiners are preferred.

Additional Information

• Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
• The Company may assign other tasks, duties, and job responsibilities at its sole discretion.
• Equivalent experience, skills, and/or education will also be considered.
• The Company will determine what constitutes as equivalent to the qualifications described above.
• Nothing contained herein should be construed to create an employment contract.
• The Company is committed to compliance with the Americans with Disabilities Act.