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

IQVIA Inc; Stockholms kommun; On-site; SEK 1,200,000 - 1,800,000; Full time

Job summary

IQVIA Inc. is seeking an experienced Principal Statistical Programmer to provide technical leadership across Phase I-IV clinical trials, driving high-quality programming solutions, regulatory submissions, and study-level strategy.

You will lead programming activities, mentor teams, develop and review TLFs with SAS and R, and ensure adherence to CDISC standards while collaborating with cross-functional stakeholders to enable successful submissions.

Qualifications

• Bachelor's or Master's degree in statistics, mathematics, computer science, life sciences, or a related field.
• Minimum 8+ years of statistical programming experience in pharma/biotech/CRO.
• At least 2+ years as Study Lead/Lead Programmer overseeing trials.
• Strong SAS (Base/Macro) and R skills with regulatory submission experience.
• Knowledge of CDISC standards (SDTM/ADaM) and regulatory requirements.

Responsibilities

• Lead statistical programming activities across multiple clinical studies.
• Serve as Study Lead, mentoring programming teams.
• Develop, validate, and review TLFs using SAS and R.
• Drive standards, efficiencies, and process improvements.
• Author programming specs, validation plans, and study documentation.
• Support regulatory submission packages in compliance with standards.
• Collaborate with cross-functional stakeholders to resolve data issues.
• Develop reusable programming tools and solutions.

Skills

Leadership

Cross-functional collaboration

Project management

Communication

Clinical trial data knowledge

Education

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

Tools

SAS Base / Macro

R programming

SDTM / ADaM

Pinnacle 21

Regulatory submissions

Job description

Join our growing FSP team supporting a global pharmaceutical client. We are seeking an experienced Principal Statistical Programmer to provide technical leadership across Phase I-IV clinical trials, driving the delivery of high-quality statistical programming solutions, regulatory submissions, and study-level programming strategy.

Key Responsibilities

• Lead statistical programming activities across multiple clinical studies and programs.
• Serve as a Study Lead, providing oversight, mentorship, and technical guidance to programming teams.
• Develop, validate, and review analysis datasets, tables, listings, and figures (TLFs) using SAS and R.
• Drive programming standards, efficiencies, and process improvements across studies and therapeutic areas.
• Author and review programming specifications, validation plans, and study documentation.
• Ensure high-quality delivery of regulatory submission packages in compliance with industry standards.
• Collaborate with Biostatistics, Data Management, Clinical, and other cross-functional stakeholders to resolve data and programming issues.
• Support strategic initiatives through the development and implementation of reusable programming tools and solutions.

Required Qualifications

• Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field.
• Minimum 8+ years of statistical programming experience within the pharmaceutical, biotechnology, or CRO industry, demonstrating increasing levels of responsibility.
• At least 2+ years of experience as a Study Lead/Lead Programmer, leading programming activities across clinical trials; alternatively, experience developing SAS/R solutions implemented across multiple studies, programs, or therapeutic areas.
• Intermediate/Advanced programming expertise in SAS (Base and Macro) and R.
• Strong knowledge of CDISC standards (SDTM, ADaM, Pinnacle 21) and regulatory submission requirements.
• Proven experience supporting efficacy analyses, statistical reporting, and regulatory deliverables.
• Experience developing and reviewing programming specifications and technical documentation.
• Strong understanding of clinical trial data, including study population, efficacy, safety, and PK/PD analyses.
• Demonstrated leadership, project management, and organizational skills, with the ability to manage multiple priorities across studies and programs.
• Excellent communication skills with experience collaborating across cross-functional teams and engaging with key stakeholders.

Preferred Qualifications

• Hands-on experience with R programming in a clinical development environment.
• Experience supporting global regulatory submissions (FDA, EMA, PMDA).
• Previous experience working within an FSP model supporting pharmaceutical sponsors.
• Experience driving programming innovation, automation, and standardization initiatives.

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.