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 professionals operating in more than 90 countries. Our mission is to innovate drug and device development for our partners and enhance 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 prestigious and innovative pharmaceutical companies. You will often have the chance to lead studies through various stages of the clinical development process and assist with submissions, regulatory inquiries, publications, as well as ad hoc and post hoc requests.

Key Responsibilities:

Evaluate Statistical Analysis Plans (SAPs) and Tables, Figures, and Listings (TFL) shells from a programming perspective. Provide guidance on the creation of complex TFL shells. Develop and oversee the creation 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 and define XML/PDF documents, Analysis Results Metadata (ARM), and Reviewers Guides to support SDTM and ADaM datasets. Address Quality Assurance (QA) and client audits and assist with qualification audits. Identify and suggest innovative methods 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).

Your Profile:

A degree in a relevant discipline such as mathematics, life sciences, statistics, or computer science. Alternatively, an equivalent vocational training and/or professional experience in statistical programming for clinical trials. Significant professional experience as a statistical programmer within a biotech, CRO, or pharmaceutical environment. Proven expertise in base SAS, SAS macros, and SAS/STAT, with demonstrated ability to debug SAS programs. Extensive experience with SDTMs, 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 preferred. Experience with submissions is advantageous. Excellent organizational skills, a collaborative work style, a curious mindset, and meticulous attention to detail. Fluency in English, both spoken and written, is essential.

Work Environment: This position offers the flexibility of being 100% home-based in EMEA or the option to work from a local office in your home country.

What We Offer:

Meaningful work within a well-established, diverse, and respected global organization. Competitive compensation packages, including various local benefits such as pension contributions and health insurance plans. A genuine commitment to work-life balance. Flexible working hours. Comprehensive onboarding with support from a personal mentor. A permanent employment contract with MAI Fortrea Development Limited. Excellent training and career development opportunities, along with support for advancing your education. Strong backing from your Line Manager and team, as well as from over 20,000 colleagues worldwide.

MAI Fortrea Development Limited is actively seeking motivated individuals who are passionate about overcoming challenges in clinical trials. Our unwavering commitment is to transform the development process, ensuring the rapid delivery of life-changing therapies to patients in need.

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