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Biostatistician

Date:  Apr 6, 2021
Location: 

MA, US, 01923

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

 

Patients First | Innovation | Winning Culture | Heart Recovery
 

 

The Biostatistician provides statistical expertise to the clinical development program for assigned projects to ensure that scientifically valid conclusions are drawn concerning claims with respect to efficacy and safety of Abiomed products and experimental research projects under development.

We are looking for a strong member of our growing Department of Statistics, to expand, develop and play a key role in supporting Abiomed’s growing analytical needs and statistical planning of large-scale prospective trials.

Reporting to the Associate Director of Statistics, the Biostatistician will take part and lead work across the various domains of our clinical development area, including trial design, data analyses for regulatory submissions and scientific publications, and will play a significant role in multi-disciplinary project and study teams. The  Biostatistician will have close interaction with various steering committees of Abiomed sponsored prospective randomized trials and registry studies

The Biostatistician will participate in  the analyses and documentation of complicated datasets for research projects; produce and review statistical outputs; interpret and explain results; provide input into study reports and abstracts/manuscripts while ensuring completeness and accuracy.

Principle Duties and Responsibilities:

  • Provide statistical inputs in clinical program development
  • Participate in trial design, sample size calculation and protocol development
  • Develop statistical analysis plan (SAP) and TLF shells
  • Perform statistical analysis and validation according to SAP
  • Review case report forms and support eCRF development
  • Generate randomization schema and related documentation
  • Review DSMB outputs for pivotal studies
  • Perform statistical analysis and review the outputs for annual reports and quarter safety updates for on-going studies
  • Prepare and review clinical study reports
  • Develop the internal guidelines and Standard Operating Procedures (SOPs)
  • Prepare project updates for weekly/monthly status meetings
  • Attend weekly core team meetings
  • Maintain up to date knowledge in statistical methodology and FDA guidance
  • Provide statistical support for Abiomed’s publication office

Qualifications:

  • PhD or MS in Statistics, Biostatistics, Mathematics, or similar area
  • Proficient in SAS programming with minimum of 2 years of experiences
  • Extensive experience in conducting simulation study in R
  • Experience in trial design and statistical analysis plan development
  • Strong knowledge of statistical methodology in clinical trial research
  • Adequate knowledge in Data Management
  • Working knowledge of Good Clinical Practice guidelines/regulations
  • Strong oral and written communication skills
  • Ability to work collaboratively with others in a team environment
  • Ability to multi-tasking

 

 

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.


Nearest Major Market: Boston