Senior Statistical Programmer Lead

hace 2 semanas

Buenos Aires, Argentina Innovaderm Research A tiempo completo
About the Role

We are seeking a highly skilled Senior Statistical Programmer to join our team at Innovaderm Research. As a key member of our Biostatistical team, you will be responsible for leading the development, maintenance, and validation of annotated Case Report Forms (aCRFs) and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and Tables, Listings, and Figures (TLFs).

Key Responsibilities
  • Lead the development of aCRFs and statistical programming of SDTM datasets, ADaM datasets, and TLFs for clinical trials.
  • Collaborate with Biostatistical study teams and departments to produce deliverables of the highest quality, within agreed timelines and budget.
  • Review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and Data Management (DM) documents.
  • Support Data Management with data cleaning activities, programming, reporting, and reviewing statistical data issues.
  • Develop and maintain specifications and primary or QC statistical programming of SDTMs, ADaMs, and TLFs.
  • Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21.
  • Use global SAS macros to increase efficiency of statistical programming.
  • Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and IAs.
Requirements
  • 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 guideline; CDISC certification an asset.
  • Excellent knowledge of drug development process, ICH guideline, relevant Health Canada and Food and Drug Administration regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP.
  • Very organized and detail-oriented, with effective project planning and time management skills.
  • Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands.
  • Must be able to work independently and as part of a team.
  • Strong verbal and written communication skills in English.
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. As such, we will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

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