Sr. Statistical Programmer

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

The Sr. Statistical Programmer will be responsible for providing hands-on data analysis support in clinical project teams. This individual will participate in the design, development, documentation, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data and analysis results for Abiomed studies. This individual will participate in departmental and cross functional technology development and process improvement activities.

Key Responsibilities:

• Utilize SAS to generate and validate tables, listings, and figures (TLF) based on SAP
• Use major statistical programming language to perform data analysis for various needs
• Provide statistical analysis support for post approval studies
• Evaluate and ensure CDISC compliance of study tabulation and analysis data files
• Write specifications and statistical programs to generate analysis datasets and outputs
• Perform data analysis tasks with minimal supervision
• Provide programming support for data management
• Develop statistical toolbox for advanced data modelling, tabulation, and visualization
• Participate in reviewing and validating data analysis results

Qualification:

• Strong SAS programing skill in producing various types of outputs such as TLFs and datasets with minimum of 3 years of experiences
• Extensive statistical programming experience in producing deliverables either on scheduled or adhoc basis
• BS degree in Statistics, Mathematics, Computer Science, or related field, MS in Statistics or Biostatistics is preferred
• Experience with producing outputs submitted to the FDA and other regulatory agencies
• Excellent organizational skill to prioritize multiple tasks and goals to ensure timely completion
• Attention to detail and able to adapt to a fast-paced environment
• Ability to work both independently and in a cross-functional team
• Excellent communication skills
• Sufficient knowledge in CDISC and SDTM/ADAM for FDA submission compliance
• Adequate knowledge in clinical trial research methodology, ICH, GCP and regulations
• Experiences in medical device and cardiovascular disease is desirable, but not required

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. Abiomed maintains a drug-free workplace.