Sr. Clinical Database Programmer/Analyst
Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.
The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit pulsebiosciences.com to learn more.
Why Join Us?
At Pulse Biosciences, we are driven by purpose and innovation.
- Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards. We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.
- Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.
- Our Commitment: Hiring the best and brightest minds to advance our world-class organization.
What You Will Experience:
- Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!
- Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!
- Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!
- Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.
- Ownership and Rewards - Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.
- Work-Life Balance - Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.
- Diversity & Inclusion - A commitment to providing a respectful work environment to our diverse workforce.
About the Role
The Sr. Clinical Database Programmer/Analyst is responsible for specifying, developing, validating, and executing databases related to clinical systems and applications within eClinical technologies. You will also be responsible for providing data management support to the Clinical Data Management team and Clinical Operations team.
To Make an Impact, You Will:
- Create and develop clinical databases and data transfer files according to written specifications.
- Develop and evaluate database configurations, including edit checks, derivations, and form/field dynamics in collaboration with Clinical Data Management.
- Troubleshoot complex database issues and analyze data to identify trends and patterns.
- Handle pre-processing and loading of non-CRF data files.
- Assume responsibility for all DM activities (from study start-up to database lock) within project timelines including but not limited to data reviews, resolving data discrepancies, performing UAT, authoring/reviewing data management documentation (Data Management Plans, Data Review Guidelines, eCRFs, clinical database specifications and snapshot forms)
- Manage programming data exports from various sources, developing complex subject profiles/cohorts, and creating listings in multiple output formats like PDF and XML.
- Coordinate interim analyses, database snapshots, and final database lock, ensuring data integrity for regulatory filings and publications
- Assist with producing reports, tables, listings, and figures for clinical study reports (CSRs) and publications.
- Develop safety datasets for trial level reporting for submission to regulatory agencies.
- Create high level presentations that represent clinical data outcomes for Clinical Affairs management on a monthly basis.
- Collaborate with the project team to ensure that deliverables are completed on time with high quality.
- Maintain all project documentation as required by SOP and Processes.
To Excel, You Will Bring:
- Bachelor’s degree in Computer Science, Informatics or a combination of education, training, and experience that provides the required knowledge
- Experience with SQL scripting/Clinical SAS programming is preferred.
- EDC systems build expertise and custom function programming experience.
- Knowledge of EU regulatory agencies, FDA/ISO guidelines, and industry standard practices regarding data management.
- Demonstrate understanding of clinical data structures and communicate database design concepts to clinical study teams.
- Demonstrated ability to produce clinical data deliverables.
- Demonstrate strong analytical skills.
- Flexibility and ability to manage multiple priorities simultaneously.
- Ability to work independently and perform assigned tasks with minimal supervision.
- Team player with strong verbal and written communication skills.
- Demonstrated ability to learn new technologies, applications, and techniques.
- Ability to review and understand medical/technical data.
- Ability to articulate technical challenges internally and to external study-related personnel.
- Ability to lift 10-15 pounds.
Ready to Shape the Future of Healthcare?
Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation. To learn more about us, visit our website at www.pulsebiosciences.com.
We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS.
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