Senior or Principal Statistical Programmer - Japan

Proclinical is seeking a Senior or Principal Statistical Programmer to join a dedicated team, focusing on both clinical and non-clinical studies. This role involves supporting regulatory submissions, producing and validating high-quality datasets and outputs, and adhering to timelines. The successful candidate will work independently with CDISC SDTM and ADaM guidelines, create complex macros, and review Statistical Analysis Plans. The position offers flexibility in working arrangements and occasional travel for events.

Responsibilities:

• Program and confirm 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 within studies and perform user acceptance testing.
• Create, QC, and update complex dataset specifications for multiple studies.
• Provide consultancy and training on SDTM, ADaM, and CRT standards.
• Stay informed on changes to CRT and define.xml standards and regulatory guidelines.
• Lead programming efforts on multiple studies, ensuring quality and timely delivery.
• Collaborate with study 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, Mathematics, or a related discipline.
• Proven working history with SAS programming within the pharmaceutical industry.
• Understanding of clinical trial design, implementation, and regulatory submissions.
• Familiarity with GCP and regulatory requirements.
• Knowledge of SDTM and ADaM CDISC standards.

If you are having difficulty in applying or if you have any questions, please contact Nic Choa at n.choa@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.