Senior Analyst, Clinical Data Systems

Abb Vie Data Science Team Role

Abb Vie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.

Responsibilities

• Ensures that the requirements of each study protocol are reflected in systems designs and that common data standards are used
• Ensures that systems are specified to optimize on functionality, end user experience, and data flow
• Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to clinical systems (e.g., EDC, IRT). Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
• Ensures that TA- and program-level consistency is achieved
• Interacts with and influences DSS and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Abb Vie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
• Responsible for coaching and mentoring Data Science Associates
• Participates in DSS and cross-functional innovation and process improvement initiatives

Qualifications

• Bachelor's degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred
• Must have 3+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 5+ years of experience in a similar technical role or in a clinical development role. Experience with common industry design and development tools preferred
• Demonstrated understanding of clinical trial process
• Knowledge of CDASH and SDTM
• Demonstrated ability to influence of others without direct authority
• Demonstrated effective communication skills
• Demonstrated effective analytical skills

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.
  
  This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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Pay Range: $84500 - 162000 USD

Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays.

Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.