• Job Description

  Req#: R03841

  California, US residents click here.

  The job details are as follows:

  What We Do

  We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
  

  We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
  

  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, and other orphan diseases.
  
  How you’ll contribute
  The Clinical Data Management Programmer is responsible for both programming and various data management tasks for phase I - IV clinical & non-clinical trials. The CDM Programmer will create new and modify existing programs across multiple studies, which primarily are used for data cleaning. Additionally, this position will be responsible for supporting Data Management (DM) Lead with several DM assignments (e.g., opening/closing queries, user administration) throughout the lifecycle of a project with goal to ensure completeness, accuracy and consistency of the data to meet the quality standards required for reporting to regulatory bodies. This is a hybrid position with 3 days/week onsite in our RTP, NC office, and the option to work 2 days/week from home.
  

  • Generate or modify SAS programs used for data cleaning (e.g., external checks, reconciliation between EDC and vendor)
  • Develop SAS programs &/or workbooks for ad hoc review of metadata (e.g., monitoring status, missing pages, audit trail review) and reconciliations
  • Support the review of discrepancy output and validation listings, issue and track queries, and reconcile data from external databases and non-CRF data sources
  • Administer user access to Electronic Data Capture (EDC) and keep documentation up-to-date, as needed
  • Participate in project team meetings and other cross-functional initiatives as needed
  • Support DM team with design, validation, and implementation of clinical databases for designated studies
  • Assist data management colleagues with database testing and reviews as needed
  • Reconcile project files and other documents generated in data management for accuracy and completeness
  • Assist in setting up and maintaining Standard Operating Procedures (SOPs) and working practices for data management
  • Occasionally liaise with study monitors to address data issues and provide resolutions
  • Submit related documentation to TMF
  • Perform all other duties as required

  
  For this role you will need

  Minimum Requirements

  • Bachelor’s degree in life sciences, biotechnology, computer programming or other relevant field. Will consider commensurate experience and/or combination of education and experience.
  • 2+ years of experience in clinical trials at a pharmaceutical, medical device or CRO company
  • 2+ years of SAS programming experience
  • Knowledge of Base SAS, SAS Macro, SQL or other SAS products being proficient with FREQ, IMPORT, EXPORT procedures and ODS OUTPUT
  • Experience using SAS within clinical trials (e.g., DM or Statistical Programming)
  • Knowledge of DM processes, including CRF development and data cleaning
  • Proficient with formulas, scripts and other advanced functionality in Microsoft Excel or similar
  • Ability to communicate and present effectively
  • Working knowledge of FDA regulations, ICH GCP guidelines, CDISC standards including CDASH and SDTM, and drug development process
  • Good attention to detail; performing quality and accurate work
  • Strong organizational and time management skills
  • Technologically savvy with the ability to quickly pick up new information, standards and regulations, tools and software as related to role
  • Proficient in word processing software and relational databases
  • Excellent verbal and written communication skills

  Preferred Qualifications

  • 3+ years of experience in clinical trials at a pharmaceutical, medical device or CRO company
  • 4+ years of SAS programming experience
  • SAS Certified Professional: Clinical Trials Programming Using SAS 9.4 and
  • SCDM Certified Clinical Data Manager or Certified Clinical Data Associate
  • Prior experience working with electronic data capture systems; Medidata Rave, Medrio EDC

  At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

  Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

  While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

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

• About the company

  United Therapeutics is a biotechnology company listed on the NASDAQ.

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