Senior Biostatistician

Location

Dover, DE | United States

Job description

at J&J Family of Companies in Dover, Delaware, United States

Senior Biostatistician – 2306159306W

Description

Abiomed, part of Johnson & Johnson’s MedTech, is recruiting for a Senior Biostatistician located in Danvers, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company.

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

Reporting to the Director of Statistics, the Senior Biostatistician will work across various domains of our clinical development, including trial design, data analyses for regulatory submissions and scientific publications, and will play a crucial role in multi-disciplinary project and study teams.

Responsibilities:

+ Develop trial design options and provide statistical guidance for on-going and planned clinical studies

+ Participate in planning, design, development, and execution of clinical trial protocols

+ Develop statistical sections of clinical study documents, including but not limited to study synopsis/protocol and clinical study report

+ Develop statistical analysis plan ( SAP ) based on study protocol and produce TLF shell according to SAP

+ Produce and validate statistical analyses and outputs according to SAP

+ Lead and support data analyses to enable generation of clinical evidence manuscripts

+ Perform quality control and validation of peer statistician and statistical programmer’s work

+ Provide validation and review services for internal and external projects. Write up and communicate findings as necessary

+ Maintain archives of study data and relevant programming documentation

+ Participate in the development of internal guidelines and Standard Operating Procedures

+ Conduct statistical simulations for evaluating and developing novel clinical trial designs

+ Prepare project updates for weekly/monthly status meetings

+ Maintain up to date knowledge of statistical methodology and relevant regulatory guidance

Qualifications

+ PhD or MS in Statistics, Biostatistics, Mathematics or similar area

+ Requires 5 years relevant work experience

+ Minimum of 5 years of clinical research experience in medical device, pharmaceutical, biotech and/or CRO industries

+ Extensive experience in clinical trial design, data analysis and interpretation, as well as regulatory interaction and/or submission

+ Proficient in major statistical programming languages such as SAS and R

+ Adequate knowledge in Database Management

+ Ability to work collaboratively with others in a team environment

+ Strong interpersonal skill and communication skill

For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $100,000 to $150,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. For additional general information on company benefits, please go to:

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Primary Location NA-US-4887-Danvers

Other Locations NA-United States

Organization ABIOMED Inc.(6942)

Job Function Biostatistics

Req ID: 2306159306W

Job tags

Salary