MMS logo
MMS

The difference is in the data.

Senior Statistical Programmer

Software EngineerSoftware EngineerFull TimeRemoteSeniorTeam 501-1,000H1B SponsorCompany SiteLinkedIn

Location

India

Posted

31 days ago

Salary

0

Seniority

Senior

Job Description

Senior Statistical Programmer

MMS

Role Description Mastery in 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. - 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. - 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. - 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 teamwork. - Support objectives and improvement efforts within department and organizationally. - Comply with all applicable policies, procedures, and training requirements. - Additional tasks as assigned by manager. Qualifications - 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 programs such as SAS procedures. - Excellent organizational and communication skills.

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Defense Unicorns logo

Software Engineer - Mid-Senior

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We help mission-focused heroes solve the world’s biggest software challenges.

Full TimeRemoteTeam 51-200H1B No Sponsor

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General Motors logo

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