Senior Technical Business Analyst – Clinical Study Design and Analysis

The Senior Technical Business Analyst drives technology initiatives and projects with end-to-end accountability for delivering business value. This role leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers, testers, and business teams to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT systems. This role will collaborate with product managers, other business analysts, system administrators, testers, developers, and business stakeholders with high technical literacy to maintain an efficient and consistent delivery process focused on quality, compliance, and business continuity. 

Roles & Responsibilities:  

• Enable and evolve Clinical Study Design and Analysis functional capabilities through delivery of technology implementations and projects 

• Apply independent judgment and decision-making to define scope, drive alignment, and ensure outcomes are delivered 

• Collaborate with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals 

• Capture the voice of the customer to define business processes and product needs 

• Provide technical feasibility assessments in real-time during requirements elicitation  

• Work with Product Managers and customers to define scope and business value for new developments 

• Collaborate with Engineering on design specifications 

• Collaborate with Product Owners to prioritize release scopes and refine the product and capability backlogs 

• Partner with business analysts in other regions to delegate project responsibilities based on time zone and access to relevant stakeholders 

• Define project timelines and drive delivery of system implementations, enhancements, and release validation to meet the communicated plans 

• Ensure non-functional requirements are included and prioritized in the product and release backlogs 

• Facilitate the breakdown of Epics into Features and sprint-sized User Stories and participate in backlog reviews with the development team 

• Clearly express features in User Stories/requirements so all team members and stakeholders understand how they will be achieved 

• Translate complex business and technological needs into clear, actionable, and testable requirements for development and validation teams 

• Ensure Acceptance Criteria are well-defined 

• Work closely with Software-as-a-Service suppliers to meet business requirements with configuration, custom releases, and roadmap prioritization 

• Manage project timelines and deliverables to ensure delivery targets are met and stakeholders are informed of progress 

• Develop and execute effective product demonstrations for internal and external stakeholders 

• Participate in code and design reviews to ensure standards and best practices are followed 

• Maintain accurate documentation of requirements, configurations, processes, and changes 

• Manage change control and documentation lifecycles in strict adherence to standard operating procedures (SOPs) 

• Identify and manage risks associated with the systems, including technological risks, validation, and user acceptance 

• Bachelor’s degree with 6 - 8 years of experience in a Technical Business Analyst role OR 

• Diploma with 10 - 12 years of experience in a Technical Business Analyst role 
   

Functional Skills: 

Must-Have Skills: 

• Writing comprehensive functional and non-functional requirements for development and implementation of business applications in a GxP regulated environment 

• Project delivery following Agile software development methodologies (Scrum) 

• Excellent communication skills and the ability to interface with senior leadership with confidence and clarity 

• Technical thought leadership and highly conversant in software engineering, system architecture and integrations, and data sciences terminology 

Good-to-Have Skills: 

• Excellent problem-solving skills and a passion for tackling complex challenges in clinical development with technology 

• Demonstrated expertise in a clinical development domain and related technology needs 

• Understanding of biostatistical analysis methods 

• Experience in managing product features for PI planning and developing product roadmaps and user journeys 

• Familiarity with low-code, no-code test automation software 

• Experience with the latest generative AI capabilities, including building agentic AI workflows and/or custom GPTs 

• Able to communicate technical or complex subject matters in business terms 

• Jira Align experience 

• Knowledge of Databricks and AWS cloud platforms 

• Experience with Software-as-a-Service application implementations and release management and validation 

Professional Certifications: 

• SAFe for Teams certification (preferred) 

Soft Skills: 

• Able to work under minimal supervision 

• Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work 

• Excellent analytical and gap/fit assessment skills 

• Strong verbal and written communication skills 

• Ability to work effectively with global, virtual teams 

• High degree of initiative and self-motivation 

• Ability to manage multiple priorities successfully 

• Team-oriented, with a focus on achieving team goals 

• Strong presentation and public speaking skills 

Shift Information: 

This position may require you to work a later shift schedule. Candidates must be willing and able to work during evening, as required based on business requirements.