Senior Statistical Programmer

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.

Job Description

• Mastery and train on generating tables, listings, and graphs from clinical trial databases using SAS.
• Utilizes System Development Life Cycle (SDLC) for programming deliverables.
• Advanced user in SAS programming, SAS Base, and SAS Macros. •Advanced knowledge of E-Submission Standards, Guidelines and Regulations.
• Mastery and train on SDTM standards including ability to write specifications.
• Advanced knowledge of ADaM standards including supporting specification writing.
• Proficient with MS Office applications.
• Advance knowledge of ICH, 21CRF Part 11, and ISO 9001:2000 requirements.
• Advanced experience with pooling of data sets for submissions.
• Advanced experience with BIMO outputs, define.xml, Reviewer’s Guides, SDSP.
• Lead study or small programming project teams
• Independently manages tasks and projects to achieve set objectives. Provides guidance to more junior level colleagues.
• Identifies and suggests opportunities for improvement related to Service and/or Service Line at the project level and may contribute to improvements.
• Actively contributes ideas, suggestions and best practices in interactions with the external and internal customers. Frequently supports Business Development activities and customer kick off meetings.
• Experienced professional who knows how to apply theory and put it into practice with in-depth understanding of the professional field; independently performs the full range of responsibilities within the service; possesses broad job knowledge; analyzes problems/issues of diverse scope and determines solutions.
• May lead projects or project steps within a broader project or have accountability for ongoing activities or objectives.
• Proactively stays abreast on external industry and technology developments; able to diagnose internal and customer gaps and propose relevant solutions.
• Maintains high level of confidentiality related to customer and internal projects.
• Exercises high degree of judgment regarding the information that can be disclosed internally and externally.
• Solves complex problems; takes a broad perspective to identify solutions.
• Effectively communicates with wide audiences internally, presents at expert webinars and department-wide and/or company-wide meetings.
• May lead functional teams or projects.
• Provides technical mentorship and guidance to colleagues within specific areas
• Produces high quality project deliverables across multiple, high complexity projects with high level of efficiency.
• Represent self and company in a professional manner and in line with core company values.
• Practice excellent internal and external customer service, communication, and team work.
• Support objectives and improvement efforts within department and organizationally.
• Comply with all applicable policies, procedures, and training requirements.
• Additional tasks as assigned by manager.

Minimum Requirements

• College graduate in computer science or related field required, Masters preferred, or related experience.
• 5-9 Years of prior programming experience preferred; interested in expanding knowledge of drug development as it pertains to programming.
• Has high level knowledge of drug development as it pertains to clinical programming; has the ability to apply drug development knowledge during production of high quality programs.
• Strong 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.
• Experience in pharmaceutical or CRO industry.
• 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.
• Strong resource for various programming skills; willing to guide others in a variety of new programming techniques.
• Excellent organizational and communication skills.

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