MCRA is part of IQVIA Med Tech. As a trusted CRO and advisory partner, IQVIA Med Tech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients make smarter decisions and thrive in the market. Join our team to help shape the future of Med Tech.

Overview

The Statistical Programmer is a critical biostatistics team member that will be responsible for creating and validating statistical programs. This will consist of listings, safety & efficacy outputs (analysis datasets, tables, figures) in accordance with documented procedures and project specific timelines, used to generate accurate, complete, and consistent outputs by transforming raw clinical trial data into datasets, analyzing data, providing Tables, Listings, and Figures (TLFs), and maintaining and improving analysis algorithms and processes. The Statistical Programmer may be client-facing at times and an important subject matter expert in the study team. This position will regularly collaborate with MCRA, an IQVIA business Clinical, Regulatory, and Data Management teams, as well as external partners and clients as required.

Responsibilities and Duties

• 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 ADa Ms.

• 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.

Required Knowledge, Skills, and Experience

Education: Bachelor’s degree in Mathematics, Statistics, Biostatistics, Epidemiology, or related scientific field.

Certification/Licensure: SAS certified preferred.

Experience: 2 years of experience with statistical programming in the CRO, medical device, or pharmaceutical industry is required.

• Other:

• Experience and familiarity with medical devices is highly preferred.

• 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

• An understanding of quality control as it relates to regulatory documentation requirements is preferred

• Experience with adaptive trials and Bayesian analysis techniques is desired.

• 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

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 $69,300.00 - $173,200.00. 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.