United Therapeutics Senior Clinical Data Scientist (Senior Clinical Data Manager) in Durham, North Carolina

The Job Details are as follows:

What we do

United Therapeutics is a biotechnology company that focuses on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.

We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.

How you’ll contribute

The Senior Clinical Data Scientist is responsible for creating and maintaining quality-assured clinical databases to support regulatory submissions and other project goals and timelines.

  • Coordinate data management activities across multiple projects for phase I-IV clinical trials

  • Design, develop and review Case Report Forms (CRFs) according to protocol specifications

  • Design, implement, and maintain clinical trial databases such as EDC systems

  • Execute database setup and data processing activities according to agreed standards and timelines

  • Execute QC/QA procedures to ensure that clinical databases meet corporate and regulatory standards

  • Assist in developing, testing, implementing, and documenting processes and computer programs used for data validation

  • Represent data management in project team meetings and other cross-functional initiatives

  • Communicate data management issues and database status to colleagues and customers

  • Provide data quality feedback to clinical monitors and study personnel

  • Assist in establishing and maintain data management SOPs and working practices

  • Complete training on existing and newly implemented data management systems

  • Develop training material and provide user training as needed

  • Assist in planning, selection, and implementation of new computer/software systems

  • Maintain data management study files.

  • Design, test, and maintain SAS and query programs as needed

  • Generate data listings for data reviews as needed

  • Review study protocols and acquire knowledge of therapeutic area

  • Lead process improvement initiatives

  • Present at external meetings and/or conferences as needed

  • Perform other duties as assigned

For this role you will need

Minimum Qualifications

  • BA/BS degree in mathematical, computer, or life sciences

  • 10+ years of data management and/or a combination of data management and programming experience in the pharmaceutical industry

  • Strong experience performing data query and data cleaning activities; and with performing reconciliations between clinical databases and external databases

  • Basic understanding of database concepts and practical experience with Oracle and PL/SQL

  • Strong knowledge of and professional experience using Medidata Rave and Inform

  • Knowledge of Base SAS, SAS Macro, and other SAS products

  • Excellent organization and communication skills

  • Ability to interact with and influence staff within functional and cross-functional teams

  • May need to present at external meetings or conferences

  • Proficiency with MS Office and working in a PC/Windows environment

  • Ability to travel up to 10% as needed

Preferred Qualifications

  • MS degree in mathematical, computer, or life sciences

  • Medidata RAVE Study Builder certification

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

United Therapeutics currently has five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level job performance, and provide state of the art facilities in which to flourish. This is what makes United Therapeutics a stimulating place to work. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation, and achievement into success.