909#Senior Statistical Programmer Consultant -Oncology (remote)

Job Description

ClinChoice is seeking a Senior Statistical Programmer Consultant to work directly with a single sponsor while benefiting from the stability of a global CRO. This role involves overseeing the development of CDISC-compliant datasets (SDTMs/ADaMs) by CROs, ensuring clear documentation through specifications, trackers, and checklists. The consultant will generate and review SDTM mapping specifications, annotated CRFs, ADaM specifications, define.XML documents, and reviewers’ guides, adhering to CDISC and FDA guidelines. They will be accountable for the oversight of statistical programming deliverables for both in-house and outsourced projects, providing technical leadership and problem-solving within project timelines.Role involves:

• Overseeing the development of CDISC-compliant datasets (SDTMs/ADaMs).
• Generating and reviewing SDTM mapping specifications, annotated CRFs, ADaM specifications, define.XML documents, and reviewers’ guides.
• Providing technical leadership and problem-solving within project timelines.
• Developing SAS programs and specifications for output to support study needs.
• Overseeing and managing the work of junior programmers.

Requirements:

• BS/BA degree in a related discipline.
• 8-10 years of experience in statistical programming with clinical data and SAS.
• Experience in oncology therapeutic area.
• Strong SAS programming skills (SAS/Base, SAS/Stat, SAS/Macros).
• CDISC proficiency.
• SAS/GRAPH experience (Kaplan-Meier plots, swim lane plots) preferred.
• Knowledge of relevant regulations, industry standards, and guidance documents.

ClinChoice offers:

• Opportunity to work directly with a single sponsor.
• Career opportunities within a global CRO.
• A focus on quality, professional development, and a supportive culture.

ClinChoice is an equal opportunity employer committed to diversity and inclusivity.