Associate Director, Clinical Data Systems

Company: Agios Pharmaceuticals Inc
Location: Cambridge
Posted on: April 10, 2021

Job Description:

Associate Director, Clinical Data Systems Location Agios Pharmaceuticals HQ Job Code 1539 # of openings 1 Associate Director, Clinical Data Systems Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development. Agios Pharmaceuticals is searching for a dynamic Associate Director, Clinical Data Systems to join our growing Clinical Data Systems team. The Associate Director, Clinical Data Systems serves as a subject matter expert on data visualization, reporting and analytics development for clinical studies. This position leads, contributes, and supports the integration of different clinical systems data into one data review / analytics platform to enhance efficiencies in collaboration with key stakeholders for cross-functional data review. Serves as key contact for data reporting, and standard data review platform development and implementation to meet operational excellence and enable risk-based data quality monitoring of clinical trial. This position works closely with other members of the Data Management, Clinical Operation, Biometrics and Safety team on various clinical projects with business stakeholders and CRO partners. Key Responsibilities

• Provides application administration and technical support as the subject matter expert on core business packages related to Spotfire.
• Performs Spotfire programming, testing, mapping, data feeds and documentation in accordance with programming standards and validation procedures.
• Assist in developing and implementing automation of data feeds into Spotfire.
• Program and generate data review tools such as patient profiles and targeted data listings in support of data review.
• Works with clinical trial project teams and management to adhere to quality standards and project timelines.
• Serves as a subject matter expert and provides expertise for study data review tool development, database programming, and data review standards; provides expertise on problem-solving with clinical data systems, functionality and capabilities.
• Provide accurate and timely answers to technical questions.
• Mentors and trains internal staff or external resources within Clinical Data Systems, as necessary.
• Partners with IT and QA to test and implement system upgrades for Spotfire and other data review, visualization/analytics tools.
• Develops and maintains departmental SOPs and processes related to data review, visualization/analytics tools
• BA/BS in Engineering, Computer Science, Biotechnology or related disciplines and 10+ years industry experience (Pharmaceutical, Biotech, CRO) leading technical projects and/or clinical database programming
• Experience with Spotfire administration/programming
• Demonstrated strong aptitude for data analytics, mathematical and statistical concepts
• Experience with and understanding of clinical trials and clinical data.
• Excellent problem solving, negotiation, resource allocation and organizational skills
• Proficient knowledge of data reporting and programming efficiency in SQL, PL/SQL and working with relational databases like SQL Server, MySQL, Oracle, etc.
• Demonstrated experience collaborating with various business functions
• Demonstrated technical expertise with clinical databases, data warehousing, data analytics platforms and/or data visualization tools
• Demonstrated experience working with IT and cross-functional counterparts in evaluating and implementing clinical data systems, constructing technical business requirements, specifications and supporting validation documentation
• Knowledge of regulatory guidelines, including GCP/ICH, FDA/EMA/CHMP, 21 CFR Part 11, validation requirements
• Strong experience and knowledge in the administration and development of data analytics platforms and/or data visualization tools
• Effective written and verbal communication skills Preferred Qualifications
  • Knowledge of other data visualization programming packages/languages (e.g. Tableau, S-Plus, R, Python, SAS).
  • Experience with CDISC standards is a plus

Keywords: Agios Pharmaceuticals Inc, Cambridge , Associate Director, Clinical Data Systems, Executive , Cambridge, Massachusetts