Statistical Programmer, SDTM, ADAM, TLF

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

📋 Description

• Utilize SAS or other software to create programming code for summary tables, data listings, graphs, and derived datasets in accordance with statistical analysis plans and programming specifications.

• Ensure that outputs adhere to quality standards and fulfill project requirements.

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

• Comply with applicable SOPs, work instructions, and relevant regulatory guidelines such as ICH.

• Maintain comprehensive project documentation, testing, verification, and quality-control materials to ensure inspection readiness.

• Oversee schedules and time constraints across multiple simultaneous projects.

• Create specifications for datasets and outputs of varying complexity.

• Facilitate internal meetings, disseminate information and minutes, and monitor action items.

• Deliver programming outputs on time while providing risk mitigation strategies.

• Serve as the lead statistical programmer, supervising other programming personnel and monitoring deliverables.

• Review statistical analysis plans, mock shells, programming specifications, annotated CRFs, and SAS database designs.

• Engage in sponsor, kickoff, and bid defense meetings.

• Mentor programming staff through training, work reviews, and constructive feedback.

• Act as a technical authority on clinical drug development, industry standards, electronic submissions, CDISC, SDTM, and ADaM.

• Conduct compliance reviews of CDISC deliverables, specifications, datasets, and regulatory documents such as DEFINE.XML.

• Participate in industry standards organizations and communicate updates regarding standards.

• Contribute to the development of SOPs, policies, procedures, programming tools, and macros.

• Transfer deliverables effectively.

• Execute other assigned work-related tasks.

⛳️ Requirements

• 8+ years of programming experience in Clinical Statistical Programming.

• Capability to lead multiple complex and/or global projects with teams of statistical programmers.

• Strong expertise in SDTM, ADaM, and TLF.

• Experience in writing SDTM/ADaM specifications.

• Familiarity with oncology efficacy endpoints/outputs.

• Experience with submissions to regulatory agencies is preferred.

• Proficiency in R programming.

• Exceptional written and verbal communication skills.

• Preference for immediate joiners.

• Equivalent experience, skills, and/or education may be taken into consideration.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Minimal travel may be required.