Senior Biostatistician

Successfully completed various Biostatistics projects

More than 10 years of experience as Biostatistician in clinical trials

Expert in SAS Programming

Longstanding experience in the pharmaceutical and CRO industry

Has already been successfully placed via K-Recruiting

Statistical support and lead to all aspects to their client program for one of the compounds related project (3 individual studies, incl. Oncology)

Developing study synopsis, protocol, and statistical analysis plans (SAP)

Providing daily statistical support for project/study requirements

Reviewing documents for final submissions and addressing regulatory queries from health authorities

Overseeing the CROs outsourced work

Consultation and advice in all aspects of statistical and SAS programming

Working in all phases of clinical trials, focusing on Generic, Metabolism, and Oncology

Involved in observational studies phase IV and III submission studies

Reviewing CDISC standards and developing SDTM and ADaM specifications

Leading statistical programming projects, setting priorities and timelines, and conducting team meetings for operations and stakeholder deliveries

Develop objectives, design sampling, randomization, & statistical analysis plans to achieve study objectives

Perform appropriate methodologic procedures for statistical analysis

Collaborate with data managers and investigators to align statistical analysis plan with data collection procedures and forms

Perform sample size and power calculations, generates randomization schema, and prepares statistical sections for research protocols and manuscripts