Senior Statistical Programmer

2 weeks ago

London, United Kingdom MMS Holdings Inc. 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 .

Senior Statistical Programmer

Roles & Responsibilities

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 Strong SAS programming, SAS Base, SAS Macro experience 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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