Statistical Programmer (Medical device)

Statistical Programmer (Medical device)

Remote

Regulatory Affairs – Biostatistics /

Full-time /

Remote

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MCRA, an IQVIA business, is a leading medical device advisory firm and clinical research organization (CRO). MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1500 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.

Overview

The Statistical Programmer will be a critical Biostatistics team member that will primarily 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.

This position will regularly collaborate with MCRA’s Clinical, Regulatory, and Data Management teams, as well as external partners and clients. The ideal candidate will be a self-starter that is passionate about delivering high value and assisting device manufacturers with their statistical needs in regulatory clinical trials.

Responsibilities and Duties

• Process Electronic Data Capture (EDC) data into analytical datasets.
• Create Tables, Listings, and Figures to support Regulatory Clinical Trials.
• Develop and maintain SAS programs for data importing, quality assurance, and reporting.
• Produce Define XML/PDFs, aCRFs, 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 project team members (internal and external), including Data Management personnel, Statistical Programmers, and Clinical Research 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 departments, including clinical and regulatory to support their needs in terms of biostatistical resources
• Technical writing and review of documents and deliverables.
• Represent MCRA 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.

Required Knowledge, Skills, and Experience

• Bachelor's degree in Mathematics, Statistics, Biostatistics, Epidemiology, or related scientific field.
• 3+ years of experience with statistical programming in the CRO, medical device, or pharmaceutical industry is required.
• 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.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

MCRA, an IQVIA business, is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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