Advanced Clinical Trial Data Lead

1 dia atrás


Rondônia, Brasil beBeeStatistical Tempo inteiro R$120.000 - R$140.000
Statistical Programming Lead

We are seeking an experienced Senior Statistical Programmer to lead the development and maintenance of clinical trial data. As a key member of our team, you will be responsible for creating high-quality 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).

In this role, you will:

  • Develop and maintain aCRFs according to protocol, eCRF, and industry standards.
  • Create specifications and primary or QC statistical programming of SDTMs, ADaMs, and TLFs based on protocol, aCRF, SAP, and industry standards.
  • Support data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician.
  • Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21 and address any findings appropriately.
  • Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and IAs.

To be successful in this role, you will have:

Education

A Bachelor's degree in Statistics, Computing Sciences or a related field; Master's degree an asset.

Experience

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.

Knowledge and skills

Excellent exposure to clinical trial data, SAP, TLF Shells, and specifications.



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