Senior/Principal Statistical Programmer, R/RShiny

This is a fully remote position, open to applicants in Armenia.

📋 Description

• Create custom programming code using R/RShiny or other software to produce summary tables, data listings, graphs, and derived datasets.

• Ensure that outputs comply with quality standards and meet project requirements.

• Conduct validation programming and address discrepancies with Programmers, Biostatisticians, and project team members.

• Keep team members updated on programming progress and any issues encountered.

• Adhere to relevant SOPs, WIs, and regulatory guidelines, including ICH.

• Maintain thorough and up-to-date project documentation, testing, and quality-control materials for inspection readiness.

• Oversee scheduling and time management across various projects.

• Develop specifications for datasets and outputs in accordance with statistical and sponsor requirements.

• Anticipate and resolve potential programming challenges, and define variables for peer review and sponsor/requestor acceptance.

• Prepare for and facilitate internal meetings, distribute information and minutes, and ensure action items are completed.

• Negotiate time estimates and fulfill study programming tasks within designated timelines.

• Serve as the lead statistical programmer, directing or overseeing other programming staff.

• Review Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database designs.

• Represent statistical programming in sponsor, kickoff, and bid defense meetings.

• Mentor programming personnel through training, work reviews, feedback, and guidance.

• Transfer deliverables efficiently.

• Perform additional work-related duties as assigned.

• Some travel may be required.

⛳️ Requirements

• Advanced degree in Statistics, Computer Science, or a related field.

• Significant experience in statistical programming within a clinical or pharmaceutical environment.

• Familiarity with CDISC programming standards, including SDTM and ADaM.

• Experience in conducting clinical trials and biomarker analyses.

• Proficient in R and RShiny.

• Strong knowledge of statistical methods and data analysis techniques.

• Excellent analytical and problem-solving abilities.

• Capability to work independently as well as collaboratively within a team.

• Strong communication and interpersonal skills.

• SAS Certified Advanced Programmer for SAS 9 or equivalent certification is preferred.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a total rewards program.

• An inclusive culture.

• Access to comprehensive resources, including emerging technologies, data, science, and knowledge sharing.

• Multiple career paths and employment opportunities.

• Reasonable accommodations available when appropriate.