Senior Statistical Programmer - FSP

IQVIA; Barcelona; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

IQVIA in Barcelona is seeking an experienced Clinical Programmer to join our global team. You will design and deliver SDTM/ADaM datasets, tables, figures and listings, and lead complex SAS programs for regulatory submissions across multiple studies.

You will collaborate with study teams and statisticians to ensure submission readiness, develop SAS macros, and support integrated safety and efficacy analyses. Fluency in CDISC standards and R programming is expected.

Formación

• At least 5+ years in clinical or statistical programming within CRO/pharma.
• Deep knowledge of SAS, macros and CDISC standards.
• Experience leading programming activities for pooled analyses.

Responsabilidades

• Design data structures for ADaM, SDTM, tables, figures, listings and analyses.
• Ensure submission readiness of clinical data to authorities.
• Lead complex SAS programs and develop global tools for the team.
• Collaborate with study teams and statisticians to meet timelines.

Conocimientos

SAS

R Programming

CDISC Standards

Macro Programming

Analytical Thinking

Educación

BSc in Computer Science, Mathematics, Statistics or related area

Herramientas

SAS Macros

Descripción del empleo

Nairobi, Kenya

Vienna, Austria

Warsaw, Poland

Budapest, Hungary

Kyiv, Ukraine

Barcelona, Spain

Centurion, South Africa

Prague, Czech Republic

Sofia, Bulgaria

Madrid, Spain

Bucuresti, Romania

Full time

R1571037

Main Responsibilities and Accountabilities:

Collaborates with the study teams to design data structure and specifications for ad hoc and study deliverables including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content.

Collaborates with study teams to ensure the quality and accuracy – thus submission readiness – of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml).

Leads and oversees requested efforts for pooled and exploratory analyses working closely with Statistics TA lead and/or study statisticians as well as with clinical programming team and their collection of legacy data.

Leads and oversees the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO.

Leads and oversees the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.

Leads and oversees the development of global tools that will increase the efficiency and capacity of the Statistical Programming group.

Works closely with clinical study teams to plans and executes activities to ensure project timelines are met with high quality deliverables.

Additional tasks:

• Collaborates with CR&D staff regarding data analysis requests.
• Performs additional statistical analyses including but not limited to:
• support responses to regulatory agencies,
• generate integrated summary of safety and efficacy,
• support publications and presentations,
• support planning and reporting of clinical trials via exploratory analyses of available data,

Position Qualifications and Experience Requirements:

Education

• BSc in Computer Science, Mathematics, Statistics or related area with relevant experience

Experience

• At least 5+ years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment
• Indepth understanding of clinical programming and/or statistical programming processes and standards.
• Extensive experience with statistical programming using the SAS software including development and use of SAS Macros. Strong programming and problem-solving skills.
• Good experience in R Programming is mandatory for this role (Hands on experience)
• Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
• Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities (or equivalent).
• Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
• Experience in working in cross-functional, multicultural and international clinical trial teams.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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