Purpose:

　　As a part of AbbVie’s Digital Health Function in the Development Design Center, you will have the opportunity to shape the future of clinical research. The Digital Health team is responsible for setting the strategic vision for Digital Health across the Development Organization and working across all Therapeutic Areas to bring those strategies to life in meaningful ways for AbbVie and for patients. The Principle Signal Processing Scientist will provide subject manner expertise (SME) as we advance the research and development of digital endpoints and manage all the signal processing efforts for analytical and clinical digital health device validations in collaboration with internal as well as external partners.

　　Responsibilities:

　　Lead the digital data analytics at the study level, provide data and analytics expertise for clinical study design, develop study level digital data management and analysis plan, execute the digital data analytics strategy.

　　Work with digital health strategy leaders, medical directors, and other key stakeholders supporting the asset-level digital health strategy development, DHT selection and validation

　　Perform signal processing and algorithm development in support of all therapeutic areas projects. This will include efforts to work with vendors on data transfer plans, define feature extractions, develop detection algorithms, create novel data standards compatible with HL7 or align to industry best practice or external consortia efforts.

　　Serve as a subject matter expert on digital data analytics, including sensor, imaging, audio/video data analysis and advanced algorithm development.

　　Provide SME input on the sections of documentation for regulatory agency meetings and participate in said meetings to address technical questions raised by regulatory agencies. Author sections of CSR, technical reports, regulatory submissions.

　　Support analytical validation studies of digital tools, adhere to PFDD, DDTQ, CTTI guidance as well as other relevant federal and international regulations, including GCP, ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and functional quality standards. Stay abreast of new and evolving regulations, guidelines and policies related to digital health and clinical development.

　　Establish thought leadership in digital health, algorithm development, and clinical decision support tools validation with peer-review journal publications and presentations at global congresses.

　　This role can be hired at a Sr. Manager or an Associate Director level depending on years of relevant experience; previous work, education, training, and statistics capabilities

　　Qualifications for Associate Director:

　　Graduate training in Data Science, Computer Science, Statistics, Operational Research, Mathematics, Engineering or related fields is required. MS (with 810 years) or PhD (with 68 years) of experience.

　　Preferred industry experience in pharmaceuticals and/or clinical development.

　　Strong problem-solving and data analytics skills with working experience using Python/R and related packages, e.g. scipy, scikit-learn, pytorch, tensorflow etc. Prefered experience in open-source package development

　　Methodical, detail-oriented, critical thinker with value-evidence mindset with the ability to manage competing priorities as well as collaborate and influence cross-functionally in a highly matrixed environment is desired.

　　Strong listening and communication skills, proficient in verbal and writing with demonstrated scientific publications and oral presentations to senior or large audiences.

　　Qualifications for Sr. Manager:

　　Graduate training in Physics, Mathematics, Engineering or related field required. MS (with 6+ years) or PhD (with 4+ years) of experience.

　　Preferred industry experience in tech, life science, healthcare or pharmaceutical.

　　Strong problem-solving and data analytics skills with working experience using Python/R and related packages, e.g. scipy, scikit-learn, pytorch, tensorflow etc. Prefered experience in open-source package development.

　　Methodical, detail-oriented, critical thinker with value-evidence mindset with the ability to manage competing priorities as well as collaborate and influence cross-functionally in a highly matrixed environment is desired.

　　Strong listening and communication skills, proficient in verbal and writing with demonstrated scientific publications and oral presentations to senior or large audiences.

　　AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.