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Senior Clinical SAS Programmer

MMSH Clinical Research Pvt. Ltd. is part of MMS Holdings Inc., a global clinical research organization (CRO) that focuses on regulatory submission support for the pharmaceutical, biotech and medical device industries. Our strong industry experience and scientific approach to drug development makes us a valuable partner in creating compelling submissions that meet rigorous regulatory standards. Our clients span from top 10 pharma to virtual biotechs, and we support each one with the same standard of excellence. Our core service areas include medical and regulatory writing, biostatistics, clinical programming, data management, clinical development, clinical trial disclosure, regulatory affairs, regulatory submissions and pharmacovigilance.

Our mission is to deliver high-quality services, rooted in good science and decades of regulatory experience, that will assist our clients in developing and marketing life-changing therapies, thereby positively affecting patients' lives worldwide.

Job Responsibilities

  • Confidently displays excellent internal and external customer service
  • Responsible for implementation and execution of client statistical requirements
  • 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
  • Demonstrates extensive knowledge of departmental processes (e.g. competency in programming software and willingness to share information)
  • 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
  • Complies with Document Control Procedure
  • Complies with Record Control Procedure
  • Ensures compliance to applicable ISMS policies and procedures

Job Requirements

  •  Minimum of 5 years, Work from Home option Available
  • Hard-core experience in Clinical Programming,
  • Experience in CDISC Lifecycle and development of Macros. Experience
  • Experience creating TLGs for Saf & Eff data, ISS, ISE, pooled studies, specs

 

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