Proclinical is seeking a Statistical Programmer - Submissions for a Senior position. This role involves supporting regulatory submissions, producing and validating datasets, and ensuring high-quality outputs within set timelines. The position offers flexibility in work location and requires occasional travel for events.

Responsibilities:

Program datasets including complex efficacy and lab data. Serve as an independent technical expert and program complex non-efficacy outputs. Conduct senior reviews and quality control of non-statistical outputs. Develop and implement standard macros and perform user acceptance testing. Create, QC, and update complex dataset specifications for various studies. Provide consultancy and training on SDTM, ADaM, and CRT standards. Stay informed on regulatory guidelines and implement PHASTAR CRT tools. Lead programming projects, ensuring quality and timely delivery. Collaborate with statisticians and project managers on resources and deliverables. Act as a point of contact for programming issues and ensure cohesive team operations. Develop and deliver company-wide training and update processes and SOPs.

Key Skills and Requirements:

Degree in Computer Science or another relevant field. Experience in SAS programming within the pharmaceutical industry. Understanding of clinical trial design and regulatory submissions. Familiarity with GCP and regulatory requirements. Knowledge of SDTM and ADaM CDISC standards.