Lead Statistical Programmer in Oncology

hace 3 meses

Madrid, Madrid, España MAI Fortrea Development Limited A tiempo completo

Company Overview: MAI Fortrea Development Limited is a prominent global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise. We offer a comprehensive array of clinical development, patient access, and technological solutions across over 20 therapeutic areas, employing more than 19,000 professionals in over 90 countries.

Position Summary: As a Senior Statistical Programmer within our dedicated Flexible Solutions division, you will play a crucial role in the successful execution of intricate clinical trials (phases I-III) for leading pharmaceutical companies. This position provides opportunities to oversee studies throughout various stages of the clinical development process, including support for submissions, regulatory inquiries, publications, and both ad hoc and post hoc requests.

Key Responsibilities:

  • Review Statistical Analysis Plans (SAPs) and Table, Figure, and Listing (TFL) shells from a programming standpoint.
  • Provide guidance on the creation of complex TFL shells from a programming perspective.
  • Develop and/or lead the creation of detailed specifications for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets.
  • Create and maintain SAS programs for generating SDTM and ADaM datasets and TFLs, ensuring quality control of these outputs.
  • Produce and define XML/PDF documents, Analysis Results Metadata (ARM), and Reviewers Guides to support SDTM and ADaM datasets.
  • Respond to Quality Assurance (QA) and client audits, assisting in qualification audits.
  • Identify and propose innovative strategies to enhance the efficiency, quality, and productivity of our clinical statistical programming operations.
  • Stay informed about industry standards, global regulatory requirements, internal guidelines, and Standard Operating Procedures (SOPs).

Candidate Profile:

  • A degree in a relevant discipline such as mathematics, life sciences, statistics, or computer science.
  • Alternatively, equivalent vocational training and/or professional experience in statistical programming for clinical trials.
  • Demonstrated professional experience as a statistical programmer within a biotechnology, CRO, or pharmaceutical setting.
  • Proficient in base SAS, SAS macros, and SAS/STAT, with a proven ability to debug SAS programs.
  • Experience with SDTM, ADaM datasets (safety and efficacy), and TFLs.
  • Strong understanding of CDISC standards.
  • Prior experience with oncology data (safety and efficacy) and/or vaccine trials is advantageous.
  • Submission experience is preferred.
  • Excellent organizational skills, with an autonomous and collaborative work style, a curious mindset, and meticulous attention to detail.
  • Business fluency in English, both spoken and written, is essential.

Work Environment: This position allows for 100% remote work within the EMEA region or the option to work from a local office in your home country.

MAI Fortrea Development Limited is committed to fostering a collaborative environment that encourages personal growth and the opportunity to make a significant impact on global health outcomes.

  • Lead Statistical SAS Programmer, Oncology, Single Sponsor

    hace 2 semanas

    Madrid, Madrid, España MAI Fortrea Development Limited A tiempo completo

    Transforming Oncology Research with Expert Statistical ProgrammingAs a leading global contract research organization (CRO), Fortrea is committed to delivering high-quality clinical development solutions to pharmaceutical, biotechnology, and medical device customers. We are seeking a highly skilled Lead Statistical SAS Programmer to join our team and...

  • Lead Statistical Programmer in Oncology

    hace 3 meses

    Madrid, Madrid, España MAI Fortrea Development Limited A tiempo completo

    Company Overview: MAI Fortrea Development Limited is a premier global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise. We offer a comprehensive suite of clinical development, patient access, and technological solutions across over 20 therapeutic areas, employing more than 19,000...

  • Lead Statistical Programmer in Oncology

    hace 4 semanas

    Madrid, Madrid, España MAI Fortrea Development Limited A tiempo completo

    Company Overview: MAI Fortrea Development Limited is a premier global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise. We offer a comprehensive suite of clinical development, patient access, and technological solutions across over 20 therapeutic areas, employing more than 19,000...

  • Lead Statistical Programmer in Oncology

    hace 4 semanas

    Madrid, Madrid, España MAI Fortrea Development Limited A tiempo completo

    Company Overview: MAI Fortrea Development Limited is a premier global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise. We offer a comprehensive suite of clinical development, patient access, and technological solutions across over 20 therapeutic areas, with a workforce exceeding 19,000...

  • Lead Statistical Programmer in Oncology

    hace 3 meses

    Madrid, Madrid, España MAI Fortrea Development Limited A tiempo completo

    Company Overview: MAI Fortrea Development Limited is a premier global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise. We offer a comprehensive suite of clinical development, patient access, and technological solutions across over 20 therapeutic areas, with a workforce exceeding 19,000...

  • Senior Statistical Programmer, Oncology, Single Sponsor

    hace 1 semana

    Madrid, Madrid, España Mai Fortrea Development A tiempo completo

    Transforming Drug Development for PatientsAt Mai Fortrea Development, we're committed to delivering complex clinical trials for top pharmaceutical companies. As a Senior Statistical Programmer in our Oncology team, you'll play a crucial role in developing and validating SAS programs for data presentations and analyses.Key Responsibilities:Develop and...

  • Lead Statistical Programmer, Oncology, Single Sponsor

    hace 2 semanas

    Madrid, Madrid, España Mai Fortrea Development Limited A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Mai Fortrea Development Limited provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas....

  • Statistical Programmer

    hace 3 semanas

    Madrid, Madrid, España Pra A tiempo completo

    Job Title: Statistical ProgrammerWe are seeking a highly skilled Statistical Programmer to join our team at ICON plc, a world-leading healthcare intelligence and clinical research organization. As a Statistical Programmer, you will play a critical role in planning, managing, and executing statistical programming deliverables in clinical trials and non-trial...

  • Statistical Programmer

    hace 3 semanas

    Madrid, Madrid, España Pra A tiempo completo

    Job Title: Statistical ProgrammerWe are seeking a highly skilled Statistical Programmer to join our team at ICON plc, a world-leading healthcare intelligence and clinical research organization. As a Statistical Programmer, you will play a critical role in planning, managing, and executing statistical programming deliverables in clinical trials and non-trial...

  • Senior Statistical Programmer

    hace 3 semanas

    Madrid, Madrid, España Iqvia A tiempo completo

    Job Title: Senior Statistical ProgrammerAt IQVIA, we are seeking a highly skilled Senior Statistical Programmer to join our team. As a key member of our programming team, you will be responsible for designing, developing, and implementing statistical programs for complex studies.Key Responsibilities:Design and develop statistical programs for data analysis...

  • Senior Statistical Programmer

    hace 3 semanas

    Madrid, Madrid, España Iqvia A tiempo completo

    Job Title: Senior Statistical ProgrammerAt IQVIA, we are seeking a highly skilled Senior Statistical Programmer to join our team. As a key member of our programming team, you will be responsible for designing, developing, and implementing statistical programs for complex studies.Key Responsibilities:Design and develop statistical programs for data analysis...

  • Senior Statistical Programmer, Oncology, Global Expert

    hace 1 semana

    Madrid, Madrid, España Mai Fortrea Development Limited A tiempo completo

    Key Responsibilities:As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Mai Fortrea Development Limited provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20...

  • Senior Statistical Programmer

    hace 1 semana

    Madrid, Madrid, España Pharmiweb A tiempo completo

    Job Title: Senior Statistical ProgrammerAt Syneos Health, we are seeking a highly skilled Senior Statistical Programmer to join our team. As a Senior Statistical Programmer, you will be responsible for developing custom programming code to generate summary tables, data listings, graphs, and derived datasets as specified in the statistical analysis plan and...

  • Statistical Programmer II

    hace 3 semanas

    Madrid, Madrid, España Icon Clinical Plc A tiempo completo

    Statistical Programmer II Job DescriptionAt ICON Clinical Plc, we're committed to advancing and improving patients' lives through clinical development. As a Statistical Programmer II, you'll play a crucial role in our mission by working on medical device and late phase research projects.Key Responsibilities:Design and develop SAS programs to generate...

  • Statistical Programmer II

    hace 3 semanas

    Madrid, Madrid, España Icon Clinical Plc A tiempo completo

    Statistical Programmer II Job DescriptionAt ICON Clinical Plc, we're committed to advancing and improving patients' lives through clinical development. As a Statistical Programmer II, you'll play a crucial role in our mission by working on medical device and late phase research projects.Key Responsibilities:Design and develop SAS programs to generate...

  • Senior Statistical Programmer, Oncology, Global Impact

    hace 2 semanas

    Madrid, Madrid, España Mai Fortrea Development A tiempo completo

    Transforming Drug and Device DevelopmentMai Fortrea Development is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across...

  • Senior Statistical Programmer

    hace 2 semanas

    Madrid, Madrid, España Iqvia A tiempo completo

    Job Overview:As a Senior Statistical Programmer at IQVIA, you will be responsible for performing, planning, and coordinating complex studies, including programming, testing, and documentation of statistical programs. You will also program analysis databases, transfer data, and provide advanced technical expertise to internal and external clients.Key...

  • Senior Statistical Programmer

    hace 4 semanas

    Madrid, Madrid, España IQVIA A tiempo completo

    Job Title: Senior Statistical ProgrammerAt IQVIA, we are seeking a highly skilled Senior Statistical Programmer to join our Global Biostatistics team. As a key member of our team, you will be responsible for providing technical expertise to develop process methodology for the department to meet internal and external clients' needs.Key Responsibilities:Plan...

  • Senior Statistical Programmer

    hace 4 semanas

    Madrid, Madrid, España IQVIA A tiempo completo

    Job Title: Senior Statistical ProgrammerAt IQVIA, we are seeking a highly skilled Senior Statistical Programmer to join our Global Biostatistics team. As a key member of our team, you will be responsible for providing technical expertise to develop process methodology for the department to meet internal and external clients' needs.Key Responsibilities:Plan...

  • Senior Statistical Programmer

    hace 3 semanas

    Madrid, Madrid, España Iqvia A tiempo completo

    Senior Statistical Programmer Job DescriptionWe are seeking a highly skilled Senior Statistical Programmer to join our Global Biostatistics team at IQVIA. As a key member of our team, you will provide technical expertise to develop process methodology for the department to meet internal and external clients' needs.Key Responsibilities:Develop and implement...