Clinical Data Management Specialist

1 semana atrás

Buenos Aires, Brasil beBeeData Tempo inteiro R$95.000 - R$119.000
Lead Clinical Data Programmer

The position of Lead Clinical Data Programmer involves leading clinical data programming efforts for single and/or multiple clinical trials. The programmer will be responsible for developing, maintaining, and validating annotated Case Report Forms (aCRFs), specifications, and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, Tables, Listings, and Figures (TLFs), and submission packages.

  • Develop/maintain/validate aCRFs according to protocol, eCRF, and Sponsor's standards and interpretation of CDISC SDTM Implementation Guideline (IG) and Controlled Terminology (CT).
  • Develop/maintain/validate specifications and Primary or QC statistical programming of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs based on protocol, aCRF, SAP, TLF Shells, Sponsor's standards and interpretation of CDISC SDTM IG, ADaM IG, and CT.
  • Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs.
  • Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21.
Key Responsibilities

The successful candidate will lead teams, review statistical programming scope of work and budget, develop/maintain/validate aCRFs, specifications, and statistical programming, and participate in internal initiatives to increase efficiency and quality of Statistical Programming activities/deliverables.

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 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.
  • Ability to work in high-speed environment with agility to juggle and prioritize multiple demands.
  • Must be able to work independently and as part of a team.
  • Strong verbal and written communication skills in English.
Our Benefits

At our company, you will enjoy a stimulating work environment and attractive advancement opportunities. Our values are collaboration, innovation, reliability, and responsiveness.

  • Flexible work schedule.
  • Permanent full-time position.
  • Ongoing learning and development.

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