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Clinical/Regulatory
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240534 Requisition #

About the Role: We are looking for a Clinical Statistical Programmer to join our Medical team. In this role, you will primarily focus on developing, maintaining, documenting, and validating programs in support of Clinical investigations.

 

This is a remote position, and you can work from home in most locations within the United States. 

 
Responsibilities:
  • Program analysis datasets, statistical tables, listings and figures in support of Clinical for all phases of the Clinical endeavor in conjunction with biostatistician(s) and other programmer(s). This includes programming in accordance with specification documents and working independently to ensure independent validation
  • Perform data exports and produce expected programmed output as-needed in support of Clinical investigations, making sure that expected outputs are delivered according to the needs of the team/regulatory
  • Establish specifications for analysis datasets, summary tables and listings, which includes creating analysis dataset specifications and working with the biostatistician to confirm clarity
  • Work closely with the Clinical team to formulate Case Report Forms (CRFs) with the goal to have the variables and the study database structure work effectively
  • Produce clear, well-documented, and efficient programs with the knowledge to develop local macros and utilize global macros. Will also need to debug programs (including those written by other programmers) when necessary
  • Sustain flexibility and efficiently use time available to support multiple studies at the same time, participating in team meetings and communicating with teams as-needed and prioritizing needs in conflict
  • Research data issues and/or questions pertaining to the clinical study data, including identifying and assisting in meeting the programming needs of data management or other teams, as necessary
  • Maintain knowledge of industry and regulatory trends and clinical trial terminology as required to meet business needs
  • Comply with standard operating procedures (SOPs) and recommended policies, including training expectations for this role
  • Participate in process improvement initiatives

Required Qualifications: 

  • Bachelor's degree in a computer-related or research discipline or minimum 5 years of significant SAS programming experience
  • Minimum 1 year of professional SAS programming experience
  • Strong knowledge of SAS including: Base SAS, SAS Macro Language, SAS ODS facility, SAS GRAPH, and SAS STAT
  • Strong verbal and written communication skills
  • Proven ability to work effectively in a fast-paced, team-oriented environment
  • Enabled to work equally well independently and with teams
  • Ability to simultaneously support multiple clinical trial projects
  • Ability to travel up to 5%

 

Desired Qualifications: 

  • Minimum 2 years of SAS Programming experience in a clinical trial environment or comparable programming experience including familiarity with statistical analysis methods and terminology
  • R programming experience
  • CDISC experience

 

Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).

 

What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

 

We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits

 

We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.

 

Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations. 

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

 

Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description. 

 

Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact

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About Gore

For 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what's possible — not just through our products and technologies but also through individual growth and development.

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