Sr. Biostatistician

5 - 7 years experience  •  Medical Devices & Diagnostics

Salary depends on experience
Posted on 02/22/18
Danvers, MA
5 - 7 years experience
Medical Devices & Diagnostics
Salary depends on experience
Posted on 02/22/18

ABOUT US

Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives.   We have a single guiding mission:  “Patients First.”   With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,000 employees form one of the fastest growing medical technology companies in the world.  Abiomed attracts and retains exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development. 

JOB DESCRIPTION

As part of the Clinical Research team, 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.

KEY 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

QUALIFICATIONS

  • Master in Biostatistics or in a related subject with a high statistical content
  • Minimum of 5 years of Biostatistics experience in the medical device, pharmaceutical, biotech and/or CRO industries, with experience in managing data from Phase III and IV clinical trials
  • Solid experience in the design and analysis of clinical trials is required (sample size, power calculation, propensity scores, multi-variate analyses. Knowledge in Baysian approach is a plus)
  • Proficient knowledge of SAS and other statistical/data transfer applications
  • Knowledge and experience with various clinical databases (e.g., Medidata RAVE, Oracle InForm and key technologies (e.g., Scanning/Imaging, IVRS/IWRS, ePRO)
  • Good verbal and written communication skills
  • 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 with excellent prioritization and organizational skills
  • Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required
  • Phase III and IV experience
  • Excellent communication, written and interpersonal skills
  • Self-sufficient and able to work with minimal oversight
  • Demonstrate leadership skills and the ability to lead teams and motivate team members, as needed
  • Able to prioritize and handle multiple tasks and studies simultaneously
  • Able to manage indirect staff, as needed; Ability to develop project management objectives, as needed
  • Proficiency with MS Word, Excel, Outlook and PowerPoint

ID:467353

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