Lead Clinical Trials Data Specialist

Há 2 dias

Rondônia, Brasil beBeeClinical Tempo inteiro R$120.000 - R$140.000

**Lead Clinical Trials Data Specialist Role Summary**

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The ideal candidate will be responsible for leading single and/or multiple clinical trials, ensuring 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).

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The Lead Clinical Trials Data Specialist will also review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and various Data Management (DM) documents (e.g., electronic Case Report Forms (eCRFs), edit checks, etc.), support DM with data cleaning activities, use global SAS macros and participate to internal initiatives to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs, and use Pinnacle 21 to validate SDTMs, ADaMs, and define.XMLs.

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This role requires a collaborative approach within Biostatistical study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Indero's standard operating procedures (SOPs) and processes.

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Key responsibilities include adhering and promoting company organizational values and related expected behaviors, following company SOPs and processes for all deliverables, and ensuring all trainings assigned to oneself are completed on time. The successful candidate will also 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, review and provide input into various DM documents (e.g., eCRF, edit checks, etc.), SAPs, and TLF Shells, and develop/maintain/validate (as applicable) aCRFs according to protocol, eCRF, and Indero and/or Sponsor' standards and interpretation of Clinical Data Interchange Standards Consortium (CDISC) SDTM Implementation Guideline (IG) and Controlled Terminology (CT).

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Additionally, the Lead Clinical Trials Data Specialist will be responsible for developing/maintaining/validating (as applicable) specifications and Primary or QC statistical programming (as applicable) of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs based on protocol, aCRF, SAP, TLF Shells, Indero and/or Sponsor's standards and interpretation of CDISC SDTM IG, ADaM IG, and CT and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). This role also involves validating SDTMs, ADaMs, and define.XMLs using Pinnacle 21 and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable).

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To succeed in this position, you must have excellent exposure to clinical trial data, SAP, TLF Shells, and specificati

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