Lead Statistical Programmer

Lead Statistical Programmer

POSITION SUMMARY

Position Summary

The Lead Statistical Programmer will work with the Clinical Affairs and Clinical Operations group and support data analysis and reporting for clinical trials and regulatory submissions. He/She leads statistical programming activities internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components and ad hoc analyses. He/she partners with Biostatistics and data management to deliver high quality, submission ready statistical outputs. This person is also 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. He/she accomplishes tasks and communicates issues, as necessary, to senior management. This includes communication and quality oversight of vendors. He/she is comfortable representing the Statistical Programming perspective to the clinical project team and is often the sole functional representative. He/she develops and implements standard programming practices while also ensuring that they are employed across studies. He/she also contributes to improve the tools and processes for Statistical Programming.

ESSENTIAL FUNCTIONS

Core Responsibilities

 

• Serve 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.
• 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/drug program audit and inspection readiness activities as needed

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:   

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

• Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• 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, CDISC, ICH, GCP, and 21 CFR Part 11 rules and regulations.
• Familiarity with clinical data management concepts and experience of data monitoring and cleaning Preferred Qualifications
• Experience in ad hoc programming to produce analysis for various projects in a short timeframe.
• 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.
• Excellent interpersonal skills and ability to negotiate and collaborate effectively
• Strong analytical skills and Attention to detail including proven ability to manage some competing priorities.

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