The Senior Clinical Data Programmer/Analyst II is responsible for developing, testing, and maintaining applications, tools, and data integrations to support the management of clinical study data. This role is responsible for utilizing a variety of different data sources, electronic platforms, and environments to handle clinical data acquisition and data management. Additionally, this role is responsible for ensuring quality of Clinical Data Management deliverables through compliance to established procedures and practices.
Essential Duties and Responsibilities
Act as Lead Clinical Data Programmer/Analyst on complex to highly complex clinical studies and projects, either independently or by directing others; provide expert Clinical Data Management functional representation to study/project teams.
Design, create, configure, and maintain novel or complex clinical study databases and related tools; including screen design, edit check development, query management, data extraction, and data management related reporting.
Programmatically combine and manipulate complex electronic data from a variety of sources.
Program using SAS, SQL, and other technical platforms, including complex data step programming, complex SAS macro programming, complex data reporting and other complex technical infrastructure associated with clinical study data.
Utilize business Intelligence tools, such as Tableau or PowerBI, to create effective automated reporting of clinical data.
Design, develop, and maintain novel integrations, automations and applications using a variety of modern APIs and web services for clinical data systems including EDC, CTMS and eTMF.
Perform database development in Electronic Data Capture (EDC) systems, including complex code-level development for edit check programming and dynamic entry screen programming.
Efficiently execute software development lifecycle procedures, including requirements gathering, risk assessment, and programming validation. Perform necessary documentation of these activities.
Interact with Exact Sciences study team members, collaborators, vendors, or partners to gather or define complex business requirements, plan deliverables, and communicate progress and findings.
Prepare and maintain complex technical documentation, as required, by departmental procedures, best practices, or project-specific needs. Review technical documentation of peers to ensure compliance to established standards.
Comply with established department and company processes, procedures, guidelines, and best practices.
Train others on complex company processes, procedures, guidelines, and best practices.
Contribute to the ongoing development and improvement of department procedures by being primary author of complex process documents and by effectively and actively contributing to or leading complex process discussions.
Collaborate with colleagues from Biostatistics, Non-clinical biostatistics, Clinical Operations, Regulatory Affairs, Medical, R&D, Pathology, Information Technology, and Program/Project Management to ensure Clinical Data Management needs and status updates are addressed and well-communicated.
Lead project teams with defined objectives or interactively lead project teams to establish objectives on not-yet established projects.
Provide appropriate support and coordinate with other functional areas regarding overall clinical data handling, automation, and data integrations.
Actively maintain knowledge and understanding of current team, department, and corporate goals and priorities to ensure effective time management and focus. Assist in developing department goals.
Exercise excellent oral, written, and presentation communication skills.
Ability to deliver quality results in a timely manner, either independently or by directing others.
Apply excellent organization skills and detail orientation.
Ability to work effectively with coworkers, external (non-Exact Sciences) contacts, and excellent negotiation and conflict resolution skills.
Ability to be highly effective in a fast-paced and rapid growth environment.
Ability to receive and apply feedback in a professional manner; ability to convey both positive and constructive feedback to others.
Ability to work effectively within a cross-functional team-oriented environment; ability to lead teams and interactively establish team objectives.
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
Support and comply with the company's Quality Management System policies and procedures.
Regular and reliable attendance.
Ability to lift up to 10 pounds for approximately 5% of a typical working day.
Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
Ability and means to travel between Madison locations.
Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
Qualifications
Minimum Qualifications
Bachelor's degree in Life Sciences, Computer Science, Scientific or related field.
8+ years of relevant work experience.
Basic computer skills to include Internet navigation, Email usage, and word processing.
Proficient in Microsoft Office to include Excel macros and pivot tables and Word mail merge.
Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Authorization to work in the United States without sponsorship.
Preferred Qualifications
Masters degree in Life Sciences, Computer Science, Scientific or related field.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.
