Statistical Programmer (Medical device)

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.