logo

Biostatistician

  • Permanent
  • Anywhere

Website Zoll Circulation Inc.

Zoll Circulation Inc.

Company : Zoll Circulation Inc.

Country: United States

Location : San Jose, California

Post: Sun, 19 Sep 2021 16:33:10 GMT

Expires: Sun, 17 Oct 2021 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Overview:
ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

 

We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

 

The Biostatistician will be responsible for interim and final statistical analysis to assess the efficacy and safety of the medical device.

Responsibilities:
Provide statistical support to the development of the protocol, perform sample size, and power calculation.

Prepare and maintain statistical analysis plans (SAP) in accordance with the protocol. Provide statistical input including the formulating study endpoints, implementing appropriate statistical analysis methods.

Create a randomization schedule per study design and relevant specifications.

Provide statistical interpretations of results in clinical study reports

Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trial data using SAS. Create and maintain programming documents; document changes to SAS code, programs, and specifications.

Contribute to the development of the clinical trial database, including the electronic Case Report Form (eCRF) design, User Acceptance Test (UAT), and data transfer specifications. Assist in generation database snapshots for regulatory submissions and data status verification reports.

Ensure adherence to industry standards and regulatory requirements, including but not exclusive to Good Clinical Practices (GCP) and ICH guidelines on Statistical Principles for Clinical Trials.

Represent Biostatistics in study and project team meetings.

Qualifications:
Strong statistical programming and analysis skills in SAS or R

Demonstrated interpersonal skills are essential, as well as strong organizational and communication skills

Education/Training/Experience Requirements:

Master’s Degree in biostatistics, mathematics, life sciences, or related field

Knowledge of regulatory requirements for clinical trials

Knowledge of CDISC Guidelines

1-2 years of work experience in the medical device industry or 4 years of medical research

 

#LI-HL1

To apply for this job please visit www.resume-library.com.