Principal Stat Programmer, SDTM, ADaM, TLF

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

📋 Description

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

• Ensure that outputs align with quality standards and fulfill project requirements.

• Execute validation programming and address discrepancies or findings in collaboration with programmers, biostatisticians, and project team members.

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

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

• Maintain comprehensive and current project documentation, including testing, verification, quality control documents, and programs.

• Oversee schedules and time constraints across various projects, adjusting workload in response to changing priorities.

• Create specifications for datasets and outputs of varying complexity.

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

• Ensure timely delivery of concurrent programming deliverables and formulate risk mitigation plans.

• Act as the lead statistical programmer, guiding programming activities and overseeing deliverables.

• 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.

• Serve as a technical authority on clinical drug development, industry standards, and electronic submission requirements.

• Collaborate with biostatistics and statistical programming personnel to establish SOPs, guidelines, policies, and procedures.

• Develop programming tools and macros aimed at standardization and efficiency.

• Offer guidance and training on CDISC standards.

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

• Engage in industry standards organizations and communicate forthcoming changes to standards.

• Transfer deliverables as required.

• Execute other assigned work-related duties.

⛳️ Requirements

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

• Demonstrated experience in statistical programming and data analysis.

• Strong proficiency in SAS, R, or Python.

• Familiarity with data visualization tools and techniques.

• Exceptional problem-solving and analytical skills.

• Capability to work independently while managing multiple projects concurrently.

• SAS Certified Advanced Programmer for SAS 9 or an equivalent certification.

• Preferred certification in data analysis or statistical programming.

• Proficient in statistical programming and data manipulation.

• Solid understanding of statistical methodologies and data analysis techniques.

• Ability to develop and implement effective programming solutions.

• Excellent communication and teamwork abilities.

• Keen attention to detail and a commitment to maintaining quality.

• Flexibility to adapt to evolving project requirements and priorities.

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive culture.

• Minimal travel may be necessary.