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Principal Statistical Programmer

salary Salary :

$9,300 - 9,500 monthly

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Job Description - Principal Statistical Programmer

Responsibilities

  • Ensure all programming-related tasks are performed with high scientific and technical quality in compliance with SOP and policies.
  • Familiar with the systems used in the Biometric Division, such as the Clinical Data Repository. Also, CDISC standards, MedDRA, and WHODRUG Dictionaries.
  • Identify and participate in the development and implementation of new procedures and methodologies to increase the accuracy and efficiency of the programming processes.
  • Participate actively in meetings, discussions, knowledge sharing, and activities covering all aspects of clinical data programming.

Tasks

  • Collaborate with Clinical Data Managers and produce all required SDTM datasets.
  • Generate ADaM datasets.
  • To work with Biostatisticians, by providing summaries and output for Phase I-IV clinical study reports, clinical trial registries, and integrated reports of efficacy and safety.
  • Perform Review/QC and documentation of the programming.
  • Assist in the development and QC of tools and programs implemented in the Biometric Division.
  • Perform role as Oversight Statistical Programmer for outsourced clinical trials

Qualifications:

  • Degree in Statistics/Computer Science/Engineering or equivalent
  • More than 8 years of relevant experience as a Statistical Programmer in Pharmaceutical related industry
  • Statistical, analytical, or equivalent work experience preferred
  • Excellent SAS Programming experience
  • Strong analytical and problem-solving skills for the design, creation, and testing of programs
  • In-depth knowledge of CDSIC (Clinical Data Interchange Standards Consortium) in SDTM (Study Data Tabulation Model) and ADAM (Analysis Data Model)
  • A solid team player, and at the same time able to work independently
  • Good communication and coordination skills and ability to make decisions
  • Fluent in written and spoken English
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LUNDBECK SINGAPORE PTE. LTD.

LUNDBECK SINGAPORE PTE. LTD.

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