Sr Lab Data Analyst

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Purpose

Serve as primary point of contact for customer on data management deliverables.  Provides clinical lab data expertise as part of a team to develop and maintain Laboratory Data Management (LDM) for assigned clients/studies awarded to Q2 laboratory and meets the external client data reporting needs.  Uses multiple approaches or technologies to solve a problem within established standards and procedures.  Understand and comply with core standard operating procedures and working instructions

Responsibilities

• Manage projects working with customer data managers and internal team members to ensure protocol adherence, workload projections, and provide technical expertise. Serve as a Laboratory Data Analyst for several global studies and serve in a leadership role.
• Interact with internal and external team members to negotiate timelines and responsibilities and to help resolve issues dealing with clinical trials data.
• Lead projects in the design, development, testing, documentation, and maintenance of SAS computer programs for implementing data transmittal processes and department support processes.
• Works with programming team, functional leads, project managers and all other stake holders to identify, develop and implement project solutions.
• Identify database set up and programming gaps and solves issues through using the global issue escalation/communication policy; may develop moderate to highly complex SAS Programs within scope of assignments.
• Support DM service delivery with comprehensive DM process and technical expertise in executing projects which includes identifying and resolving issues.
• Track service performance and provide leadership to identify root causes of issues.
• Understand and verify error logs generated by the LIMS Data Transmission creation and SAS QC programs and  troubleshoot and update the SAS program to resolve any issues in the Data Transmission.
• Create, review and/or sign-off on all appropriate data management documents.
• Ensure service and quality meet agreed upon timelines and deliverables in data transmission agreements; look for opportunities to improve service; work with team to develop plan to re-organize and drive change across multiple projects/program (with minimal support).
• Ensure the internal and external customer queries are addressed and resolved effectively.
• Participate in and support RFP process (review RFP documents, pricing, may attend bid defense).  Provide justification for and participate in negotiations with customer relative to project details, e.g., timelines, financial, process, resources.
• Train and mentor junior Data Analyst staff in DM and SAS expertise.

Required Knowledge, Skills and Abilities

• Extensive SAS Data Programming experience, preferably with Clinical Data.
• Strong customer-focus perspective with skill to guide customer communications and customer management
• Keen attention to detail to anticipate, address and/or escalate issues, with aptitude to embrace and be conduit for change
• Strong project and task management capabilities and ability to manage multiple projects and tasks simultaneously
• Strong problem-solving skills as well as ability to proactively identifying process improvements which reduce operational costs and maintain quality
• Quality conscious with high degree of ethics and integrity carrying out duties in accordance to laws, regulatory standards, and with company policies and procedures
• Proficiency in Windows operating systems (user-level skills), Microsoft Office applications
• Strong understanding of medical, clinical research, and Lab Data Management process and terminology
• Good knowledge of various regulatory requirements such as FDA, ICH, ISO HL7, and GLP (Good Laboratory Practices)

  Minimum Required Education and Experience

• Bachelor’s degree or educational equivalence in computer, life sciences or a related field, or a related field with 5 year of relevant work experience including programming experience or combination of computing qualification and professional experience; or equivalent combination of education, training and experience.
• Strong SAS/ Certification highly preferred.
• Customer Service Experience.
• Exposure to working with Clinical Data highly preferred.

What We Offer

• Major Medical, Vision, Dental, Disability
• Annual bonus
• 401(k) with 100% with immediate vesting
• Tuition Reimbursement up to $6k annually
• Generous paid time off and holiday leave
• Other generous benefits

EEO Minorities/Females/Protected Veterans/Disabled