Principal Statistical Programmer, ADAM, TLF, SDTM

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

📋 Description

• Create SAS or other software programming codes to produce 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 meet project requirements.

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

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

• Maintain thorough project documentation, including testing, verification, and quality-control programs for inspection readiness.

• Oversee schedules and priorities across multiple simultaneous projects.

• Develop intricate dataset and output specifications based on statistical or sponsor requirements.

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

• Ensure timely delivery of concurrent programming outputs and provide risk mitigation strategies.

• Serve as the lead statistical programmer, guide other programming staff, and oversee the progress of 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 staff through training, work reviews, feedback, and guidance.

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

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

• Offer guidance and training on CDISC standards.

• Conduct compliance reviews of CDISC deliverables, including SDTM and ADaM specifications and datasets as well as DEFINE.XML.

• Participate in industry standards organizations and communicate forthcoming standards changes.

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

⛳️ Requirements

• A minimum of 8 years of experience in Clinical SAS Programming.

• Extensive expertise in Base SAS/SAS Macros.

• Proficiency in SDTM, ADaM, and TLF programming.

• Experience in creating specifications.

• Practical experience with both Safety and Efficacy data.

• Preferred experience in the Oncology therapeutic area.

• Experience with ISS/ISE.

• Knowledge of R programming.

• Exceptional written and verbal communication skills.

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

• Preference for immediate joiners.

• Some travel may be necessary.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition.

• Comprehensive total rewards program.

• A Total Self culture promoting authenticity and employee well-being.

• A workplace culture that focuses on diversity, inclusion, and a sense of belonging.