As part of the Clinical Development team led by the Chief Medical Officer, the Biostatistician provides statistical expertise and guidance to the clinical development programs to ensure that scientifically valid conclusions are drawn concerning claims with respect to efficacy and safety of ABIOMED clinical studies and experimental research projects under development. The candidate is expected to be the most qualified expert in Biostatistics at Abiomed and therefore he/she will have the opportunity to support or provide guidance for all statistical activities in all phases of project related clinical development program. He/She will play an active role in multi-disciplinary project and study teams.
Primary Duties and Responsibilities:
Contribute to the development and maintenance of the Biostatistics methods and procedures based on Regulatory Guidelines and Company requirements
Responsible for the development of statistical analysis plan, statistical methods, experimental design and analysis of clinical small, randomized, non-randomized trials and observational registries. Perform clinical meta-analyses by pooling data from several studies
Analyze and interpret data of individual trials, registries and publication projects
Provide guidance to Data manager for the development and maintenance of current and future databases
Responsible of the quality, accuracy and timely completion of study/project analyses
Develop project analysis plan, including computer-generated table specifications, statistical analysis plan, and research report format
Responsible for data processing for accurate relocation, formatting, generating and transmitting required data
Prepare statistical contribution to Integrated Study Report
Contribute to the formulation of regulatory strategic plans and execution
Skills/Requirements
Job Qualifications:
Proven track record for similar role for at least 4 years is required.
Solid experience in the design and analysis of clinical trials is required (sample size, power calculation, propensity scores, multivariate analyses. Knowledge in Baysian approach is a plus).
Master in Biostatistics, or in a related subject with a high statistical content.
Proficient knowledge of SAS and other statistical/data transfer applications
Good verbal and written communication skills
Conceptual
Positive, self-starter person looking for growth and making a difference in patient lives
Willing to work in an extremely fast pace environment who would embrace the opportunity to juggle many projects and hats
High attention to details and accuracy
Excellent prioritization and organizational skills
ABIOMED is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Veteran/Disabled.