Biostatistician

Requirements:

• Degree in an area related to statistics such as Physics, Mathematics, Engineering or a related Masters degree (or equivalent knowledge/degree in Science)
• 3 years industry experience.
• Advanced knowledge of statistical programming tools with SAS is essential.
• MS Office.
• Experience in Oncology and/or CDISC standards will be a plus.
• Intermediate level of English. Fluency in Spanish preferred.

Responsibilities:

 Company is looking for an experienced Biostatistician for the Clinical Development department. Depending on the Biostatistics Manager, their main role will be to participate in the design of clinical trial protocols, as the analysis and statistical interpretation of the generated data.

• Write statistical sections of protocols and other related documents  including statistical components like IRC, IDMC charters...
• Write Statistical Analysis Plan (SAP) and data analysis conventions documents.
• Statistical programming and review of outputs for Clinical Study Report (according to the SAP), publications and meetings, annual reports, regulatory documents.
• Programming of Patient Profiles and any kind of reports used by other departments.
• Macros, routines, functions for the general use of the department.
• Review, QC and documentation archive of statistical programming.
• Analysis and programming according to SDTM and/or ADAM standards.
• Oversight of Biostatistical aspects of the studies under their responsibility.
• Discuss, and review SOP, instructions and guidelines.
• Interaction and support to other departments (e.g. Marketing, Medical Affairs, PharmacoEconomics, PharmacoGenomics…).