1388# Principal Statistical Programmer Consultant Remote (Oncology)

ClinChoice

67d

About The Position

ClinChoice is searching for a Principal Statistical Programmer Consultant to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Requirements

• BS/BA degree in a related discipline.
• At least 8 – 10 years of experience in statistical programming with clinical data and SAS.
• Strong SAS programming skills required with proficiency in SAS/Base, SAS/Stat and SAS/Macros.
• CDISC proficiency required.
• Knowledge of appropriate regulations, industry standards and guidance documents.

Nice To Haves

• Experience in Rare disease/Neurology therapeutic area is a plus.
• SAS/GRAPH experience (Kaplan-Meier plots, swim lane plots) strongly preferred.
• Good interpersonal communication skills to collaborate effectively with internal cross-functional groups and external partners.

Responsibilities

• Provide oversight development of datasets (SDTMs/ADaMs) in CDISC-compliant format by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists.
• Generate and/or review SDTM mapping specifications, annotated CRFs, ADaM specifications, define.XML documents, and reviewers’ guides per CDISC and FDA specifications and guidelines.
• Accountable for oversight of statistical programming deliverables for in-house and outsourced projects.
• Provide technical leadership, problem-solving of moderate to high complexity, and within project timelines while providing high-quality deliverables.
• Independently develop SAS or other programs and specifications for production of output to support study needs, including publications, safety reporting, and ad hoc analyses in a timely fashion.
• Demonstrate expertise in SAS language, procedures, and options commonly used in clinical trial reporting, including the Macro language, BASE SAS, SAS/STAT & SAS/GRAPH.
• Oversee and manage the work of other junior programmers.
• Develop and/or validate standard macros to automate output production.
• Adhere to company SOPs and department guidelines.
• Work concurrently on multiple projects.
• Troubleshoot technical and project issues.
• Help with the infrastructure development of the department.
• Communicate effectively with internal cross-functional groups and external partners.

What This Job Offers

• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 51-100 employees