Senior Statistical Programmer (Oncology)

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

Job summary

IQVIA in Durham, NC is seeking an experienced SAS programmer to join our clinical data analytics team. You will perform statistical programming for multiple studies, generate ADaM datasets, and deliver summary tables, figures and listings in line with CDISC standards and SAP.

You will work under lead programmers, ensure documentation and validation are complete, and contribute to regulatory submissions while applying SAS macros to improve efficiency. This is a fast-paced, detail-oriented role.

Qualifications

• BA/BS in math, stats, CS or health field or equivalent experience.
• 4–8 years SAS programming in pharma.
• Strong SAS skills and attention to detail.
• Knowledge of regulatory guidelines and electronic submissions.
• Strong organizational and leadership skills; able to work under timeline pressure.

Responsibilities

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

Skills

SAS programming

CDISC standards

ICH guidelines

Regulatory knowledge

Leadership

Education

BA/BS in quantitative field

Tools

OpenCDISC

SAS macros

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 Incyte 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.