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Senior Clinical Programmer – Technical Lead

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

  • Responsible for implementation and execution of high quality clinical programming
  • Demonstrates strong understanding of ICH guidelines, as applicable to clinical programming
  • Creates programming training exercises, trains new programmers, and serves as mentor
  • Trains via self-study and self-practice independently and explores advanced topics related to clinical programming and/or drug development
  • Utilizes System Development Life Cycle (SDLC) for programming deliverables
  • Interacts directly and independently with client to coordinate all facets of the project; competent communicator
  • Works with statistical personnel 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 client needs
  •  Develops clinical programming efficiencies based on broad, in-depth knowledge of procedures
  • Follows processes related to project management as appropriate for programming projects (e.g.  updating PSS, close-out procedures etc)
  • Demonstrates extensive knowledge of departmental processes

Desired Skills and Experience

  • At least six years' work experience in programming role, preferably supporting clinical trials/ or in the pharmaceutical industry)
  • Masters in Mathematics, Statistics/ Computer Science of Health Science graduates
  • Work from home available across India
  • Advanced knowledge of/ experience with SAS and other relevant programming software
  • 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
  • Proven experience leading programmer support for multiple clinical trials and submission activities (or equivalent)
  • Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP. ICH)
  • Strong experience with data and production of TLGs
  • Thorough understanding of CDISC standards and HL-7 standards
  • Experience in pharmaceutical or CRO industry
  • Proven experience in development of advanced MACROs with high programming efficiency;
  • Working knowledge of database design/ structures and basic statistics
  • Working experience in pooling analysis datasets across multiple clinical studies (or equivalent)
  • Familiarity with ISO 9001:2008 requirements

 

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