Biostatistician
Job description
Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.
General Description
The Sr. Biostatistician/ Biostatistician will be responsible for the implementation of statistical methods for Galvanize Therapeutics company clinical trials. The individual will also oversee statistical programming and data analysis efforts for Galvanize Therapeutics sponsored clinical trials.
Key Responsibilities
Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timelines
- Provide statistical expertise and consultation on study design and interpretation of results
- Lead the development of statistical analysis plans for assigned studies
- Provide input for study documents including study protocols and clinical study reports, randomization specifications
- Collaborate with Clinical Data Management to provide input for case report form design, data review, and external data transfer specifications
- Collaboration with the study team to review data and meet data freeze and lock timelines
- Manage biometrics CROs
- Contribute to the improvement, standardization, and development of biostatistics processes and procedures
- Lead the efforts to build, maintain, and continuously improve the company’s internal SAS infrastructure
- Develop and manage reusable code for data visualization and analytics tools for reporting and exploratory analysis.
- Lead, mentor and train data scientists/statistical programmers; manage contract staff
- Assist in data analysis and results interpretation
- Perform sample size calculations
- Participate in the preparation of data for publications and/or regulatory submissions
Education and Training:. Minimum of Bachelor’s degree in statistics, biostatistics, or equivalent with 5 years of industry experience or Master’s degree in statistics, biostatistics, or equivalent with 3 years of industry experience.
Skills and Experience: Minimum of 3 years of relevant industry experience. At least 2 years practical experience with data analysis software such as SAS, R or other statistical analysis packages. Prior experience as a statistician in clinical research or clinical trials is required. Experience with medical device study design/analysis is a plus. The individual should possess strong attention to detail and ability to effectively communicate complicated statistical methods. Working knowledge of GCP and/or ISO14155 is desired.
Other: Should be willing to travel if needed, up to 20%
What we offer:
- Medical, Dental, Vision, Life Insurance, LTD/STD
- 100% company paid medical coverage for employees
- Flexible/take as you need PTO
- Paid parental leave
- Company sponsored 401(k)
https://galvanizetx.com/
At Galvanize Therapeutics, your base pay is one part of your total compensation package. This role pays between $135,000 and $150,000 per year, and your actual base pay will depend on your skills, qualifications, experience, and location.
You’ll also receive other benefits: Comprehensive medical, vision and dental coverage, retirement benefits and take as you need PTO.
Due to the nature of our business and the role, please note that Galvanize Therapeutics may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Galvanize Therapeutics is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
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