Linical Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With more than 900 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.
Linical’s European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central- and Eastern Europe.
We offer individualized solutions that are tailored to the specific needs of our sponsors. We work as integrated teams functioning with maximum transparency throughout each study, making sure that the sponsor is kept up to date on all study parameters and progress. We are dedicated to the highest standards of quality, with a special focus on the therapeutic areas oncology, immunology and CNS, based on experience and expertise.
Description of the tasks / routine work:
- Provides leadership and guidance to the Biostatistics team (e.g. Biostatistician, SAS Programmer) to ensure quality from biostatistics stand point
- Main point of contact for sponsor for SAS programming issues
- Participates within the Biostatistics team for completion of all biostatistics tasks to ensure that they are completed to required quality within the timelines for allocated projects according to contracted services
- Review and/or input to study protocol, CRF, database design and validation specifications
- Develops, tests and validates adequately documented programs for randomization scheme, analysis datasets, production of results tables, listings and figures according to the Statistical Analysis Plan
- Collaborates with biostatisticians in the creation, implementation, and maintenance of programming plans for each project accounting for timelines, resources, and quality deliverables for all project work assigned
- Ensures that all programming has been carried out per appropriate validation program standards
- Ensures that statistical programs are developed, tested, and validated prior to the target analysis date
- Assists with operational input into Statistical Analysis Plan
- Importing and exporting electronic data as required
- Interact with other departments to ensure a high level of client satisfaction through successful execution of projects
- Maintenance and archiving of statistical files, both electronic and paper
- Disciplined Work Approach, Communication, Leadership, Problem Solving, Attention to Detail, Computer Skills, Language Skills.
- It is expected that for this role a minimum of 2- 4 years’ previous experience is required.