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General Summary
The Clinical Data Analyst II under minimal supervision of the Manager of Clinical Data Management or higher, selects the appropriate data sources to develop reports and dashboards of clinical data . Working in collaboration with statisticians, data managers, clinical research staff, IT, and quality assurance staff, the Clinical Data Analyst II will provide clinical data analysis reports and tools that enhance operational processes.
Specific Duties and Responsibilities
•Collaborate with clinical team to clarify and finalize user requirement specifications for clinical data analysis tools and reports. Communicate with selected vendors and/or build reports and / or tools to meet clinical user requirements.*
•Lead technical projects like the development of risk-based monitoring programs, complex reporting and cross-form query building outside EDC, integrations between EDC and other systems, and data warehouse projects.*
•Contribute to the development and maintenance of the data warehouse used to manage libraries of clinical study data including image, source document and data files.
•Develop dashboards and reports to support the clinical team by choosing the right technique and software for each problem.*
•Independently develop reports to execute trial-specific data review/cleaning plans.
•Perform complex programming such as data import/export and data transposition (Extract- Transform-Load (ETL)) accurately. Uses advanced procedures and options.*
•Assist in the setup of programming timelines and deliverables for projects as required.
•Assist in addressing external application vendor issues, integrations, and implementations.
•Provide support for implementation of upgrades and new modules of remotely hosted vendors, acquiring all necessary documentation.*
•Partner with organizational stakeholders to create and implement data analytics best practices.
•Contribute to the build and test of clinical study databases, by defining study requirements specifications such as data validation specifications and participating in User Acceptance Testing (UAT) as needed.
•Participate in and contribute to project discussions. Communicates with team members on a regular basis.
•Utilize reports and data collection technology to identify possible data errors and questionable data trends
•Participate in audits as required.
•Provide support to senior and manager level clinical data analysts as needed.
•Mentor and support less experienced clinical data analyst staff, peers and other department staff.*
•Proactively provide process improvement feedback to management and provide input in SOP and standards updates/development.
•Maintain and continue to gain a broad overall knowledge in the field of clinical data analysis and clinical data management.
•Responsible for attending training classes and professional meetings as required.
•Create training materials for clinical users and developers.
•Document data sources and data mapping.
•Create analytical data models and tools to help empower clinical teams.
•Follow data standards policies, procedures, practices, and regulations for clinical data analysis reports and tools throughout the process of collection and submission of clinical data.
•Develops skills and shares them with others.
•Provide technical support and training on reports and tools for clinical staff.
•Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.*
•Ensure other members of the department follow the QMS, regulations, standards and procedures.*
•Perform other work-related duties as assigned.
*Indicates an essential function of the role
Position Qualifications
Minimum education and experience:
•Master’s degree in ’Mathematics, Computer Science, Economics, Life Science or related field with 0-1 years of experience or Bachelor’s degree with 2+ years of experience in data visualization, dashboarding or analytical report programming experience or an equivalent combination of relevant education and applicable job experience may be considered.
•Solid hands-on knowledge of at least one programming language (e.g. Python, SAS, R, MATLAB, C Sharp, Visual Basic, SQL) required.
Additional qualifications:
•Relational database experience preferred.
•Experience in the analysis of medical or scientific data is preferred.
•An understanding of the software development lifecycle process is preferred.
•Experience with clinical database (e.g. Medrio, InForm, RedCap, OpenClinica, RAVE) a plus.
•Knowledge of core clinical data management applications (Clinical data management systems, electronic data capture, query tools, web browser, MS Office suite) a plus.
•Able to take initiative on own project responsibilities.
•Excellent attention to detail and ability to multi-task taking into account established project priorities are essential.
•Demonstrated effective communication skills.
•Demonstrated expertise in use of required technology.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
What We Offer:
• A collaborative teamwork environment where learning is constant and performance is rewarded
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases
• A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
PENUMBRA, INC.
Affirmative Action and Equal Employment Opportunity Policy Statement
As of October 14, 2022
Penumbra, Inc. has been and will continue to be an equal opportunity employer. Employee diversity has been and will continue to be pivotal to our Company's success. Penumbra recognizes that diversity and inclusion in the workplace enhance employee engagement and stimulate innovation. To assure full implementation of this equal employment policy, we will take steps to assure that:
a)Persons are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
b)All other personnel actions, such as compensation, benefits, transfers, layoffs and recall from layoffs, access to training and education are administered without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
c)Employees and applicants shall not be subjected to harassment, intimidation, threats, coercion or discrimination because they have: (1) filed a complaint; (2) assisted or participated in an investigation, compliance review, hearing or any other activity related to the administration of any federal, state or local law requiring equal employment opportunity; (3) opposed any act or practice made unlawful by any federal, state or local law requiring equal opportunity or (4) exercised any other right protected by federal, state or local law requiring equal opportunity.
I have appointed Sharon Hughes to take on the responsibilities of EEO Coordinator. The EEO Coordinator and those designated will be responsible for the day-to-day implementation and monitoring of the Company's Affirmative Action Plan. As part of that responsibility, the EEO Coordinator will periodically analyze the Company's personnel actions and their effects to ensure compliance with our equal employment policy and administer the audit and reporting system.
If you, as one of our employees or as an applicant for employment, have any questions about this policy or would like to view portions of the Affirmative Action Plan, please contact Ines Kramer during regular business hours. This is also a reminder that employees may update their disability status at any time by completing the voluntary self- identification of disability form on UKG Pro (found in the Private Info tab).
I have reviewed and fully endorse our Affirmative Action and Equal Employment Opportunity program. Thank you for your continued assistance and support of our shared objective of equal employment opportunity for all.
Adam Elsesser
Chief Executive Officer
If you reside in the State of California, please also refer to Penumbra’s Privacy Notice for California Residents.