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 professionals in over 90 countries. Our mission is to enhance drug and device development for our partners and improve patient outcomes worldwide.

Position Summary:
As a Senior Statistical Programmer within our sponsor-focused Flexible Solutions division, you will play a pivotal role in the successful execution of intricate clinical trials (phases I-III) for leading pharmaceutical companies. You will have the opportunity to oversee studies through various stages of the clinical development process, supporting submissions, addressing regulatory inquiries, and managing both ad hoc and post hoc requests.

Key Responsibilities:
- Review Statistical Analysis Plans (SAPs) and Table, Figure, and Listing (TFL) shells from a programming perspective.
- Provide guidance on the creation of complex TFL shells.
- Develop and/or lead the formulation of detailed specifications for SDTM and ADaM datasets.
- Create and maintain SAS programs for generating SDTM and ADaM datasets and TFLs, ensuring quality control of these outputs.
- Produce XML/PDF documents, Analysis Results Metadata (ARM), annotated Case Report Forms (aCRFs), 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).

Qualifications:
- 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.
- Proven professional experience as a statistical programmer in a biotech, CRO, or pharmaceutical environment.
- Demonstrated proficiency in base SAS, SAS macros, and SAS/STAT, with a strong ability to debug SAS programs.
- Experience with SDTMs, ADaM datasets (safety and efficacy), and TFLs.
- Solid understanding of CDISC standards.
- Prior experience with oncology data (safety and efficacy) and/or vaccine trials is advantageous.
- Experience with submissions is preferred.
- Strong organizational skills, an independent 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 offers the flexibility of being 100% remote within the EMEA region or the option to work from a local office in your home country.

Additional Information:
MAI Fortrea Development Limited is committed to fostering a diverse and inclusive workplace where innovative problem-solving and creative thinking are encouraged. Our goal is to revolutionize the clinical development process, ensuring the rapid delivery of transformative therapies to patients in need.

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