Clinical Trials Specialist

Há 4 dias

Buenos Aires, Brasil beBeeStatistical Tempo inteiro R$100.000 - R$150.000
Senior Statistical Programmer Role

We are seeking an experienced Senior Statistical Programmer to lead single and/or multiple clinical trials. The ideal candidate will be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR).

  • Adhere to company organizational values and follow company SOPs and processes for all deliverables.
  • Act as a Lead Statistical Programmer on multiple single studies.
  • Review the statistical programming scope of work and budget at initiation of clinical trials and identify tasks that are out of scope.

Key responsibilities include:

  • Reviewing and providing input into various documents such as eCRF, edit checks, SAPs, and TLF Shells.
  • Supporting DM with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician.
  • Developing/maintaining/validating aCRFs according to protocol, eCRF, and Indero's standards and interpretation of CDISC SDTM Implementation Guideline (IG) and Controlled Terminology (CT).

Responsibilities Continue:

  • Developing/maintaining/validating specifications and Primary or QC statistical programming of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs based on protocol, aCRF, SAP, TLF Shells, Indero's standards and interpretation of CDISC SDTM IG, ADaM IG, and CT.
  • Validating SDTMs, ADaMs, and define.XMLs using Pinnacle 21 and addressing any findings appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician.

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 working knowledge of SAS; SAS certification an asset.

Benefits

  • Flexible work schedule
  • Permanent full-time position
  • Company benefits package
  • Ongoing learning and development

Additional Information

  • Seniority level: Not Applicable
  • Employment type: Full-time
  • Job function: Research, Analyst, and Information Technology
  • Industries: Research Services

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