Sr. Clinical Research Statistician

Getinge•North Waltham, MA

1d•$120,000 - $135,000•Hybrid

About The Position

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. As Senior Clinical Research Statistician 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.

Requirements

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 other programming languages such as SAS, Python etc. is a plus.
Prior experience working with research and/or healthcare data.
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.

Nice To Haves

Transplant surgery /medical knowledge is a plus.
Experience or knowledge of FDA regulations or submissions is a plus.

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.