Senior Statistical Programmer

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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 www.mmsholdings.com or follow MMS on LinkedIn.
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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