Senior Statistical Programmer Lead

hace 3 semanas


Buenos Aires, Argentina Innovaderm Research A tiempo completo
Job Title: Senior Statistical Programmer

We are seeking a highly skilled Senior Statistical Programmer to join our team at Innovaderm Research. As a Senior Statistical Programmer, you will be responsible for leading single and/or multiple clinical trials and developing, maintaining, and validating annotated Case Report Forms (aCRFs), as well as specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, Tables, Listings, and Figures (TLFs), and submission packages.

Key Responsibilities:
  • Lead single and/or multiple clinical trials and develop, maintain, and validate aCRFs, SDTM datasets, ADaM datasets, TLFs, and submission packages.
  • Review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and various Data Management (DM) documents.
  • Support DM with data cleaning activities, use global SAS macros, and participate in internal initiatives to increase efficiency of statistical programming.
  • Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21.
  • Act as a Lead Statistical Programmer on multiple single studies and review the statistical programming scope of work and budget at initiation of clinical trials.
Requirements:
  • Bachelor's degree in Statistics, Computing Sciences, or a related field; Master's degree an asset.
  • At least 7 years of clinical research experience in biotechnology, pharmaceutical, or Contract Research Organization (CRO) industry, including 5 years of Statistical Programming and 2 years acting as a Lead Statistical Programmer.
  • Excellent exposure to clinical trial data, SAP, TLF Shells, and specifications.
  • Excellent working knowledge of SAS; SAS certification an asset.
  • Knowledge of XML programming an asset.
  • Excellent working knowledge of CDISC standards and guidelines; CDISC certification an asset.
About Innovaderm Research:

Innovaderm Research is a contract research organization (CRO) specialized in dermatology. We offer a stimulating work environment and attractive advancement opportunities. Our values are collaboration, innovation, reliability, and responsiveness. We are committed to providing equitable treatment and equal opportunity to all individuals.



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