(Senior) Biostatistical Programmer
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.
Linicals 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.
¿Deseas recibir emails de trabajo?