Senior Statistical Programmer

4 weeks ago

Edinburgh, United Kingdom MMS Holdings Inc Full time
Biometrics - Edinburgh, Scotland, United Kingdom - Full Time

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit or follow MMS on LinkedIn .

Senior Statistical Programmer

  • Confidently displays excellent internal and external customer service
  • Responsible for implementation and execution of high quality clinical programming
  • Demonstrates strong understanding of ICH guidelines, as applicable to clinical programming
  • Creates and presents programming training exercises, trains new programmers, and serves as mentor
  • Utilizes System Development Life Cycle (SDLC) for programming deliverables
  • Trains via self-study and self-practice independently and explores advanced topics related to programming and/or drug development
  • Interacts directly and independently with client to coordinate all facets of the project; highly competent communicator with excellent client interaction skills
  • Provides high level of support to the statisticians and medical writers on all programming matters according to client requirements
  • Works with statisticians to provide definitions, documentation and review of derived variables needed to produce planned tables, listings, and graphs
  • Generates tables, listings, and graphs from clinical trial databases using SAS
  • Develops programs, verifies, validates, and maintains clinical trial databases and data entry screen using SAS and related software
  • Develops data and programming specifications jointly with other programmers and biostatisticians
  • Designs specific data presentations including creative summary tables, graphs, and patient listings
  • Assists with preparing data validation plan based on customer needs
  • Reviews data management guidelines for computer edit/validation checks
  • Independently implements and validates QC findings in compliance with the NC Handling Procedure
  • Conducts thorough self-reviews of deliverables prior to release to client; serves as high level reviewer for others
  • Follows processes related to project management as appropriate for programming projects (e.g. updating VeoProject, updating PSS, close-out procedures etc)
  • Demonstrates extensive knowledge of departmental processes (e.g. competency in programming software and willingness to share information)
  • Takes initiative to suggest and implement programming process improvements and follows through to completion
  • Leads most projects with minimal management oversight, including complex projects with multiple team members and independent coordination with the client
  • Demonstrates excellent internal and external leadership skills for projects
  • Fully accountable for providing highest quality deliverables of entire project to satisfy or exceed client requirements
  • May produce and present external company presentations providing industry visibility for the organization
  • Accountable for timelines, as well as, internal team interactions
  • Complies with Document Control Procedure
  • Complies with Record Control Procedure
  • Ensures compliance to applicable ISMS policies and procedures

Job Requirements (Minimum Education / Experience / Training / Skills)

  • Preferably a minimum of 6 years experience in the Clinical Research/Statistical Programming Environment
  • College graduate in computer science or related field, or related experience
  • Has high level knowledge of drug development as it pertains to programming; has the ability to apply drug development knowledge during production of high quality programs
  • Extensive hands-on experience with clinical trials and pharmaceutical development
  • Strong experience with data and production of TLGs
  • Strong programming and logic skills
  • Thorough understanding of CDISC standards and HL-7 standards
  • Extensive experience in pharmaceutical or CRO industry preferred
  • Thorough knowledge of clinical database structures
  • Ability to program data presentations, using program such as SAS procedures
  • Subject matter expert for SAS programming skills; willing to guide others in a variety of programming techniques
  • Strong proficiency with MS Office applications
  • Excellent organizational and communication skills
  • Strong familiarity with ISO 9001:2000 requirements

Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.

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