IQVIA · 7 hours ago
Stat Programmer 2
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. The Statistical Programmer will be responsible for creating and validating statistical programs, transforming raw clinical trial data into datasets, and collaborating with various teams to support clinical trials.
AnalyticsHealth CareLife Science
Responsibilities
Process Electronic Data Capture (EDC) data into analytical datasets
Create Tables, Listings, and Figures to support clinical trials
Develop and maintain SAS programs for data importing, quality assurance, and reporting
Produce Define XML/PDFs, eCRFs, and Reviewers Guides to support SDTMs and ADaMs
Create listing and safety outputs (analysis datasets, tables, figures) to a high standard of quality and accuracy
Create, document and validate macros at the table, listing and figure level
Maintain PDVD according to the procedures for Planning, Executing, Tracking and Documentation of Programming and Validation activities
Trouble-shoot and resolve programming issues in a timely and efficient manner
Perform the following tasks per project specific timelines under supervision, as deemed appropriate to level
Set- up standard programming directories and start-up utilities
Participate in the review of in- progress audit findings and implement corrective actions, as required
Establishes and maintains effective working relationships with clients and MCRA, an IQVIA business project team members (internal and external), including Data Management personnel, Statistical Programmers, Clinical Research personnel, and Regulatory Affairs personnel
Participates in presentations at client and investigator meetings
Assist in business development functions (i.e., provide insight on BD calls, bid defenses, etc.) to secure new clients and projects and be a proactive advisor for all types of analysis from the proposal process through the project life cycle
Interface with client/sponsor organizations as a representative of the biostatistical and statistical programming team in team meetings
Work collaboratively with other MCRA, an IQVIA business departments, including clinical and regulatory to support their needs in terms of biostatistical resources
Represent MCRA, an IQVIA business at conferences and meetings as needed
Complete other duties and projects as assigned
Ensure all work products comply fully with SOPs, regulations, standards, policies, and the mission of MCRA, an IQVIA business
Qualification
Required
Bachelor's degree in Mathematics, Statistics, Biostatistics, Epidemiology, or related scientific field
2+ years of experience with statistical programming in the CRO, medical device, or pharmaceutical industry is required
Must have expertise of R programming as well as SAS® Base, and good knowledge of SAS® graph and SAS® Macros
Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician
Strong knowledge of data standards for clinical research and statistical analysis including CDISC SDTM, ADaM, and ICH Statistical Principles for Clinical Trials
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
Ability to read, analyze, and interpret complex documents
Strong research, analytical, critical-thinking, and problem-solving skills
Must be able to manage multiple projects and deliverables simultaneously and generate meaningful results
PC/Technical skills: strongly proficient in MS Office Suite, Excel, Word, PowerPoint
Excellent oral and written communication skills and presentation skills
Preferred
SAS certified preferred
Experience and familiarity with medical devices is highly preferred
An understanding of quality control as it relates to regulatory documentation requirements is preferred
Experience with adaptive trials and Bayesian analysis techniques is desired
Benefits
Incentive plans
Bonuses
Health and welfare and/or other benefits
Company
IQVIA
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 CompanyTotal Funding
$3.5B2025-06-02Post Ipo Debt· $2B
2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
Leadership Team
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