Senior Clinical Programmer - Remote

Functional Services United States


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Senior Clinical Programmer to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

Essential Duties:

  • Creates standard and/or custom programs/reports using data analytics tools such as SAS, Tableau, or other data visualization tools to support data oversight and review by data managers or other data reviewers.
  • Collaborates with Clinical Operations, Clinical Science, Data Management, Drug Safety, Statistical Programming, and Biostatistics to develop standard and custom data reports for quality data oversight / clinical data review.
  • Assists in the management of electronic data from external data sources/vendors in partnership with the Data Management Lead. Liaises with vendors as needed to facilitate electronic data transfers and/or data specification requirements.
  • Assists in review and approval of required study documentation, including design specifications, user requirements, data transfer specifications and data standards.
  • Generates safety surveillance and/or safety quality data review outputs and patient profiles for Drug Safety and Clinical Sciences’ clinical data review 
  • Provides leadership, training, guidance, and support to other department members on data review tools such as SAS.
  • Collaborates with clients, peers, programmers, project teams, and/or requestors to clarify and finalize data specifications; uses expanded technical skills to meet evolving project needs.
  • Supports the development, delivery and maintenance of clinical data review standards, tools and systems, across various data sources (e.g., clinical data, safety and operational data).
  • Supports initiatives for Data Management, Clinical Programming, Clinical Data Science and/or Safety/Clinical Data Review bridging activities, meetings, discussions.
  • Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.

    Qualifications:

  • Science and/or Computer Systems/IT background; Bachelor’s or healthcare degree
  • Minimum 6-8 years experience in a pharmaceutical/biotech setting
  • Advanced technical expertise in databases, EDC platforms, ETL, data imports/integrations
  • Advanced programming and analytical skills using BASE/SAS, SAS/STAT, SAS MACROS
  • Data Visualization tools (like Tableau, Spotfire) and Python programming language experience a plus
  • Ability to work independently to create standard datasets, program edit checks and produce quality data review outputs
  • Demonstrated understanding of CDISC requirements and implementation guidelines, able to create and validate CDISC standard datasets
  • Good project management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude
  • Good written and oral presentation skills and ability to communicate effectively to other programmers and non-technical colleagues
  • Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment
  • Windows applications: Word, Excel, PowerPoint, etc.
  • Travel domestic and international – up to 20%