Senior or Principal Statistical Programmer - Japan
- Permanent
- Manufacturing
- Japan
This vacancy has now expired. Please see similar roles below...
探花合集 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.
探花合集 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 探花合集 is acting as an Employment Agency in relation to this vacancy.
Related jobs
Highly Competitive
Visp, Switzerland
Operator(in) im Bereich Energie-Entsorgung-Abwasserreinigungsanlage.
Highly Competitive
Amsterdam, Nederland
探花合集 is currently working alongside a medical devices company to recruit for a Clinical Integration Specialist. This is a permanent position based in The Netherlands.
Highly Competitive
Utrecht, Netherlands
探花合集 is seeking a dedicated CMC Specialist to join our client's team for a permanent role in The Netherlands.
Highly Competitive
Visp, Switzerland
探花合集 is seeking a CQV Engineer to join our client's team on a contract basis.
Highly Competitive
Visp, Switzerland
探花合集 is currently working alongside a contract manufacturing organisation to recruit for a Material Planner to be based in Visp, Switzerland.
Highly Competitive
Solothurn, Switzerland
探花合集 is currently working alongside a biotechnology company to recruit for a dedicated Senior Manager, Global Upstream MSAT. This is a permanent position based in Solothurn, Switzerland.
Highly Competitive
Stein, Schweiz
探花合集 is currently working alongside a Contract Manufacturing Organisation to recruit for a CQV Engineer GMP Warehouse. This temporary contract position is based in Stein, Switzerland.
Highly Competitive
Stein, Schweiz
探花合集 is seeking an Engineer Lead to join our partner's team on a contract basis.
Highly Competitive
Visp, Schweiz
探花合集 is currently working alongside a pharmaceutical company to recruit for a 3D CAD Coordinator. This is a temporary contract position based in Visp, Switzerland.
Highly Competitive
Reykjavík, Iceland
探花合集 is collaborating with a biotech company to recruit a Senior DSP for their team in Iceland.