Sr. Clinical Research Statistician

With a passion for life, join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it.

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screening to the transplant community.

Position

You will be responsible for the design, validation, analysis and interpretation of clinical data from multiple registries in support of product development and business objectives. The position is based out of our Waltham office in the greater Boston area. There is an option to work in a hybrid environment, at least 3 days in-office is expected.

Responsibilities

• Use advanced statistical methods to validate and analyze data
• Write efficient code for processing data utilizing R statistical software
• Create processes for validating quality and accuracy of data
• Perform statistical programming and data analysis, as well as database cleaning, verification and validation, and quality review of statistical analyses
• Manage resources, timelines and priorities for assigned projects
• Work with clinical affairs staff and clinical investigators to determine appropriate study and protocol design
• Provide statistical expertise to clinical affairs staff to ensure that the CRFs and database meet the study design needs
• Responsible for statistical analysis plans (SAP) and development of tables/listings/figures for statistical reports
• Prepare statistical methods and results sections for presentations, reports, and peer-reviewed manuscripts
• Participate in preparing and writing statistical content for 501k, Clinical Study Reports (CSRs) and other FDA required reports
• May be involved in analyses of ‘big data’ for market assessments, as well as from public sources (such as UNOS)
• Organized, self-starter, critical thinker; ability to work in a fast-paced environment with a “roll up your sleeves” attitude
• Ability to work independently and as part of a team
• Excellent oral and written communication, and interpersonal skills necessary to interact with a wide range of individuals and cross-functional stakeholders

Qualifications

• At least 4+ years (MS) or 6+ years (BS) of statistical work experience in a biomedical life science or medical device company, including programming using SAS or R statistical software
• Comprehensive knowledge of statistical methods
• Prior healthcare or medical device industry experience
• Proficiency in R programming skills in a clinical data environment with excellent analytical skills; knowledge of SAS, Python, etc. is a plus
• Prior experience working with research and/or healthcare data

Education

• Bachelor’s degree in biostatistics, statistics, epidemiology or similar quantitative field of study, required. Master’s degree or higher in biostatistics, mathematics or related quantitative field of study preferred.
• Proficient in Microsoft Office Suite.
• Transplant surgery /medical knowledge is a plus.
• Experience or knowledge of FDA regulations or submissions is a plus.

Annual Salary

120K-135K depending on experience with 5% STIP.

About Us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.