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MMS · 2 months ago

Senior Statistical Programmer (Pharma/CRO, India-Remote)

United States

Full-time

Remote

Senior Level

5+ years exp

MMS is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical, biotech, and medical device industries. The Senior Statistical Programmer will generate tables, listings, and graphs from clinical trial databases using SAS, lead programming project teams, and contribute to improvements in service delivery.

BiotechnologyHealth CareLife Science

H1B Sponsor Likely

Responsibilities

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 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

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 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

Qualification

SAS programmingCDISC standardsClinical trials experienceSDTM standardsADaM standardsData presentation programmingMS Office proficiencyCommunication skillsOrganizational skillsTeamwork

Required

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 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

Proactively stays abreast on external industry and technology developments

Able to diagnose internal and customer gaps and propose relevant solutions