Senior Statistical Programmer (FSP - Permanent Homebased) m/w/d

IQVIA Inc; Paris; On-site; EUR 70,000 - 110,000; Full time

Job summary

IQVIA is seeking an experienced Senior Statistical Programmer to support Phase I–IV clinical trials for a global pharmaceutical client. You will lead programming efforts, develop SDTM/ADaM datasets, and deliver TLFs, listings, and figures using SAS and R.

The role requires strong CDISC knowledge and experience driving regulatory deliverables with a Study Lead/Lead Programmer mindset, collaborating across Biostatistics and Data Management teams.

Qualifications

• Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field.
• Minimum 5 years of statistical programming experience in pharma/biotech/CRO.
• Strong programming with SAS (Base and Macro) and R.
• Solid knowledge of CDISC standards (SDTM, ADaM, Pinnacle 21).
• Experience supporting efficacy analyses and regulatory deliverables.
• Experience developing and reviewing ADaM specifications and reports.

Responsibilities

• Lead and contribute to programming activities across Phase I–IV trials.
• Develop, validate, and maintain SDTM/ADaM datasets, TLFs, listings, and figures using SAS and R.
• Support efficacy and safety analyses per study requirements and CDISC standards.
• Author and review programming specifications and related documentation.
• Perform QC and validation of outputs for regulatory submissions.
• Collaborate with Biostatistics, Data Management, and cross-functional teams.
• Act as Lead Programmer or Study Lead, providing oversight and technical guidance.

Skills

SAS programming

R programming

CDISC standards

Lead Programmer experience

Clinical trials knowledge

Statistical analysis

Education

Bachelor's or Master's in Statistics/Math/CS/Life Sciences

Tools

SAS

R

Job description

Join our growing FSP team supporting a global pharmaceutical client. We are seeking an experienced Senior Statistical Programmer with strong expertise in efficacy analysis, clinical trial reporting, and regulatory deliverables to support Phase I-IV studies.

Key Responsibilities

• Lead and contribute to statistical programming activities across Phase I-IV clinical trials.
• Develop, validate, and maintain analysis datasets, tables, listings, figures (TLFs), and other study deliverables using SAS and R.
• Support efficacy and safety analyses in accordance with CDISC standards and study requirements.
• Author and review programming specifications and related documentation.
• Perform quality control and validation of programming outputs.
• Support regulatory submissions and ensure compliance with global regulatory standards.
• Collaborate with Biostatistics, Data Management, and cross-functional study teams.
• Act as a Lead Programmer or Study Lead, providing oversight and technical guidance as required.

Required Qualifications

• Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field.
• Minimum 5 years of statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
• Strong programming experience with SAS (Base and Macro) and R.
• Strong knowledge of CDISC standards, including SDTM, ADaM, and Pinnacle 21.
• Proven experience supporting efficacy analyses and statistical reporting for clinical trials.
• Experience developing and reviewing ADaM specifications and regulatory deliverables.
• Strong understanding of clinical trial statistical methods, TLFs, and graphical outputs.
• Experience serving as a Study Lead or Lead Programmer on global clinical studies.
• Working knowledge of clinical trial data, including efficacy, safety, and PK/PD.

Preferred Qualifications

• Hands‑on experience with R programming in a clinical research environment.
• Experience supporting global regulatory submissions (FDA, EMA, PMDA).
• Previous experience working within an FSP model supporting pharmaceutical sponsors.

If you are looking to take a leading role within a collaborative FSP environment and contribute to the successful delivery of global clinical development programs, we would love to hear from you.

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.