Senior Statistical Programmer (Oncology)

IQVIA Argentina; Durham (NC); On-site; USD 88,000 - 221,000; Full time

Job summary

IQVIA is a leading global provider of clinical research services and healthcare insights. This role focuses on statistical programming for clinical data, ensuring adherence to ICH guidelines and SOPs, and producing CDISC-compliant datasets and outputs.

The candidate will implement SAP-driven analysis methods, generate tables and listings, validate programs, and participate in SAP preparation and TLF reviews under supervision. Strong SAS skills and regulatory knowledge are essential.

Qualifications

• BA/BS degree in mathematics, statistics, computer science or health related field, or equivalent experience.
• 4–8 years of SAS programming experience in the pharmaceutical industry.
• Strong SAS programming skills with attention to detail.
• Knowledge of regulatory guidelines, including electronic submission standards.
• Strong organizational, time management, communication and leadership skills.

Responsibilities

• Conduct statistical programming work of clinical data using SAS Software.
• Ensure programs, outputs and documentation comply with ICH guidelines and SOPs.
• Generate analysis datasets per CDISC standard and SAP.
• Implement analysis methods and produce tables, graphs, and listings; conduct adhoc analyses.
• Validate programs and results produced by colleagues.
• Assist in SAP preparation and TLF shell reviews.
• Run CDISC validation programs (OpenCDISC) to ensure ADaM CDISC compliance.
• Learn and implement client SAS macros for efficient analyses under supervision.
• Program for individual studies with minimal supervision.
• Check validation summary reports for errors and proper documentation.
• Review study CDISC validation output.

Skills

SAS programming

CDISC standards

OpenCDISC validation

Regulatory guidelines knowledge

Project coordination

Education

BA/BS in mathematics/statistics/computer science/health related

Tools

SAS

Job description

Essential Functions of the Job (Key responsibilities)

• Conduct statistical programming work of clinical data using SAS Software.


• Ensure that all programs, outputs and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs.


• Generate analysis datasets according to CDISC standard and SAP.


• Implement analysis methods according to SAP, and produce summary tables, graphs and data listings using SAS; Conduct adhoc analyses.


• Validate programs and associated results produced by other programming colleagues.


• Participate in TLF shell preparation and review, and assist statistician for SAP preparation.


• Run CDISC validation programs e.g. OpenCDISC reports to ensure ADaM datasets are CDISC compliant.


• Learn, and implement the clients standard SAS macros for efficient analyses of clinical data supervised by Lead programmers.


• Work independently to program for individual studies with minimum supervision.


• Check that the validation summary reports are clean of errors and warnings, and show proper documentation of SAS programs.


• Review individual study CDISC validation output.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• BA/BS degree in mathematics, statistics, computer science or health related field. Or equivalent experience


• 4 – 8 years of SAS programming working experience in the pharmaceutical industry.


• Good SAS programming skills and attention to details


• Demonstrated knowledge of regulatory guidelines, including electronic submission standards.


• Strong organizational, time management, communication, and project coordination and leadership skills.


• Must be able to work well under timeline pressure.


• Must be able to work on multiple tasks while coordinating others at the same time.

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 proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

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.

The potential base pay range for this role, when annualized, is $88,300.00 - $220,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.