Principal Statistical Programmer - FSP jobs in United States
cer-icon
Apply on Employer Site
company-logo

IQVIA · 1 day ago

Principal Statistical Programmer - FSP

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. In this role, you will plan and coordinate the development of integrated programming solutions for statistical programming needs, providing technical expertise and leadership while managing complex studies.

AnalyticsHealth CareLife Science
check
H1B Sponsor Likelynote

Responsibilities

Perform, plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients and (iii) the programming quality control checks for the source data and report the data issues periodically
Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies
Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies
Fulfil project responsibilities at the level of technical team lead for single complex studies or group of studies
Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines
Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables
Use and promote the use of established standards, SOP and best practices
Provide training and mentoring to SP team members and Statistical Programming department staff

Qualification

Statistical ProgrammingCDISC StandardsR ProgrammingSAS ProficiencyClinical Trial DataClinical Research ProcessesLeadership SkillsCommunication SkillsOrganizational SkillsProblem-Solving Skills

Required

Min 7+ years of CRO/Pharma Industry
Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician
Must have excellent knowledge of CDISC standards (SDTM and ADaM)
Thorough understanding of relational database components and theory
Excellent application development skills
Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results
Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes
Minimum of 7+ years of experience in Statistical Programming in pharmaceutical or medical devices industry
Good verbal and written communication skills
Ability to work on multiple projects, plan, organize and prioritize activities
Experience as technical team lead directly engaging clients and coordinating tasks within a programming team
In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Knowledge of statistics, programming and/or clinical drug development process
Advanced knowledge of R programming
Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
Should have experience with SDTM Implementation and ADaM implementation according to CDISC Standards
Must have expertise in SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/SQL
Good organizational, interpersonal, leadership and communication skills
Ability to independently manage multiple tasks and projects
Ability to delegate work to other members of the SP team
Excellent accuracy and attention to detail
Ability to lead teams and projects and capable of managing at a group level
Recognizes when negotiating skills are needed and seeks assistance
Ability to establish and maintain effective working relationships with co-workers, managers and clients
Bachelor's degree from reputable university preferably in science/ mathematics related fields

Benefits

Incentive plans
Bonuses
Health and welfare and/or other benefits

Company

IQVIA provides analytics, compliance, and management solutions to the life sciences industry.

H1B Sponsorship

IQVIA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (294)
2023 (261)
2022 (229)
2021 (208)
2020 (180)

Funding

Current Stage
Public Company
Total Funding
$3.5B
2025-06-02Post Ipo Debt· $2B
2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B

Leadership Team

leader-logo
Chris Colapietro
Vice President, Customer Engagement
linkedin
leader-logo
Jonathan Morris
VP & GM US Healthcare
linkedin
Company data provided by crunchbase