Business Analyst

Company Description

Fipsar is a premier boutique data solutions provider on a mission to empower biopharmaceutical and healthcare organizations to harness the transformative power of their data. We design and implement robust data platforms that elevate decision-making through cutting-edge AI and machine learning technologies. Our innovative solutions not only optimize clinical and commercial operations but also deliver actionable insights that drive accelerate R&D and meaningful improvements in patient outcomes.  

Role Description

We are seeking a skilled Business Analyst / Subject Matter Expert (SME) to collaborate with our data engineering and analytics teams in the design and development of a cutting-edge Clinical Operations Data Analytics Platform. You will serve as the critical bridge between clinical operations stakeholders and technical teams, ensuring that data solutions meet the business needs of clinical trial management and operational efficiency. Your expertise in clinical operations and data management will drive the development of a platform that delivers valuable insights for optimizing clinical trials.

Key Responsibilities:

• Serve as the primary liaison between clinical operations teams and data engineering/analytics teams.
• Gather and translate business requirements from clinical operations teams into detailed functional specifications for the data platform.
• Analyze clinical trial processes and workflows to identify key data points and performance metrics needed for the platform.
• Collaborate with data engineers to define data models, schemas, and ETL processes that align with clinical operations requirements.
• Provide insights on clinical data standards (e.g., CDISC, SDTM, ADaM) and ensure that data models and analytics adhere to regulatory and operational guidelines.
• Develop and maintain documentation (e.g., business requirements, process flows, data dictionaries) that guides platform development.
• Support the testing and validation of data pipelines and analytics features to ensure alignment with clinical operations goals.
• Ensure that the platform enables data visualization and reporting that provides actionable insights into clinical trial performance (e.g., timelines, patient recruitment, data quality).
• Work closely with stakeholders to define KPIs and metrics for clinical trial performance and operational efficiency.
• Facilitate cross-functional collaboration between IT, clinical operations, and biostatistics teams to ensure seamless platform development.
• Support the adoption and change management processes for end-users of the clinical data analytics platform.

Qualifications

• Bachelor's/Master’s degree in life sciences, data science, information systems, or related field.
• 5+ years of experience as a Business Analyst, SME, or similar role in clinical operations or clinical data management within the biopharma industry.
• Strong understanding of clinical trial processes, operational workflows, and regulatory requirements (FDA, EMA, ICH GCP).
• Familiarity with clinical data standards, including CDISC, SDTM, and ADaM, and experience with clinical trial data management systems (e.g., EDC, CTMS).
• Experience working with data engineering teams to define requirements for data models, ETL pipelines, and data integration.
• Strong skills in business process analysis, requirements gathering, and documentation.
• Experience with data analytics tools and platforms (e.g., Qlik Sense, Tableau, Power BI, SAS, R) is a plus.
• Excellent communication skills, with the ability to articulate complex clinical operations needs to technical teams.
• Proven ability to collaborate across functional teams, driving the successful delivery of data solutions that meet business objectives.