Stat Programmer 2

IQVIA•Washington, DC

23h•$69,300 - $173,200

About The Position

MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner, IQVIA MedTech 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 MedTech. 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.

Requirements

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

Nice To Haves

Certification/Licensure: 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.

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.
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.