This role will be based remote full-time. The role will be based in the United States.
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing clinical programming professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Clinical Programming and Data Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.
POSITION SUMMARY
The Lead Statistical Programmer works with the Clinical Affairs and Clinical Operations group and supports data analysis and reporting for clinical trials and regulatory submissions. Leads statistical programming activities internally and externally through vendors in the application of data standards, e.g., CDISC, CDASH, create and QC analysis dataset specifications in line with protocol and statistical analysis plan, develop and QC of analysis datasets, tables, listings, figures, electronic submission components and ad hoc analyses. Partners with Biostatistics and data management to deliver high quality, submission ready statistical outputs.. Contributes to improve the tools and processes for Statistical Programming.
DUTIES AND RESPONSIBILITIES
Essential Functions:
• Serves as the main point of contact for stat programming function for assigned projects, support multiple stakeholder groups which include biostats, clinical development, clinical operations, data management, medical affairs, regulatory, and safety evaluation, provide oversight to vendors.
• Develop and validate of technical programming specifications (e.g., SDTM mapping specification and ADaM specification) and programs, and generate SDTM and ADaM datasets, tables, figures and listings.
• Responsible for providing input to the overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to the clinical project team counterparts and estimating resource needs. Accomplishes tasks and communicates issues, as necessary, to senior management. This includes communication and quality oversight of vendors.
• Acts as the representative for the Statistical Programming perspective to the clinical project team and is often the sole functional representative.
• Develops and implements standard programming practices while also ensuring that they are employed across studies.
• Manage and contribute to the end-to-end programming of deliverables from CRF collections through electronic submission including preparation of electronic submissions (ESUB) components (reviewers guides, annotated CRF, define and XPTs).
• Ensure that out-sourced statistical programming/data management tasks are performed according to GCP, approved SOPs, and protocol.
• Monitor quality issues with vendors and escalates internally when needed.
• Support study-level/program-level audit and inspection readiness activities as needed.
• Take ownership of projects and drive them to completion, involving stakeholders as needed.
• Have a growth mindset and take initiative to ask questions and research to improve own knowledge base and skill sets.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
• Bachelor’s degree required, Masters or PhD in statistics, computer science, mathematics, engineering, or life science preferred.
• PhD with 2+ years, MS with 6+, BS with 8+ years of programming experience in the bio-pharmaceutical industry.
• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.
• Excellent knowledge of clinical trial research methodologies and data standards, CDISC, ICH, GCP, and 21 CFR Part 11 rules and regulations.
• Familiarity with clinical data management concepts and experience of data monitoring and cleaning
• Experience in ad hoc programming to produce analysis for various projects in a short timeframe.
• Ability to think critically and resourcefully solve problems independently
• Intellectual curiosity to learn and understand the clinical science behind each data variable and be able to do data-driven programming and analysis.
• Strong analytical skills and attention to detail including proven ability to manage some competing priorities.
• Excellent interpersonal skills and communication skills
• Ability to negotiate and collaborate effectively with external and internal partners/team members
Preferred Qualifications:
• Thorough understanding of the clinical drug development process (clinical trials Phase I-IV).
• Knowledge of regulatory requirements concerning electronic submission standards and experience in delivering one or more submissions to regulatory authorities globally.
EEO Statement
All applicants will receive consideration
Location: Anywhere
Posted: Oct. 17, 2024, 9:22 p.m.
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