Senior Statistical Programmer

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

📋 Description

• Utilize SAS or alternative software to create tailored programming code for summary tables, data listings, graphs, and derived datasets.

• Ensure that outputs align with quality standards and meet project specifications.

• Conduct validation programming and resolve discrepancies with programmers, biostatisticians, and project team members.

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

• Adhere to applicable SOPs, WIs, and relevant regulatory guidelines such as ICH.

• Maintain comprehensive, up-to-date project documentation, testing, verification, and quality-control materials.

• Manage schedules and priorities across multiple projects effectively.

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

• Proactively identify and address programming issues and define variables for peer review and sponsor/requestor approval.

• Organize and lead internal meetings, disseminate information and minutes, and ensure completion of action items.

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

• Serve as the lead statistical programmer and supervise other programming personnel.

• Oversee programming deliverables and review study documentation, including SAPs, mock shells, programming specifications, annotated CRFs, and SAS database designs.

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

• Provide mentorship to programming personnel through training, work reviews, feedback, and guidance.

• Transfer deliverables and perform other assigned work-related tasks.

⛳️ Requirements

• 5-8 years of relevant experience.

• Comprehensive end-to-end programming experience.

• Strong practical knowledge in SDTM, ADaM, and TLF development.

• Familiarity with efficacy endpoints and analyses.

• Basic understanding or training in R Programming.

• Experience in both Oncology and Non-Oncology studies.

• Significant programming experience in SAS or other required software, ideally within a clinical trial setting.

• Exceptional written and verbal communication skills.

• Proficiency in reading, writing, speaking, and understanding English.

• Graduate degree, preferably in a scientific or statistical field; a combination of education and demonstrated programming experience may be considered.

• Preference for immediate joiners.

• Minimal travel may be necessary.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive organizational culture.

• Reasonable accommodations provided when appropriate.