Jocelyn EDWARDS

Experience

• 

  UC Irvine

  Dec 2003 - Dec 2009

  6 years in cognitive sciences research (vision science, psychophysics, visual neuroscience & fMRI imaging).• Analyze data, fit mathematical models, run statistical analysis, prepare reports and manuscripts.Page 2• Presented one talk, four posters, and three oral presentations at scientific conferences. Won acompetitive travel award at a conference of 30,000 attendees.• Won a research grant from Sigma Xi, The Scientific Research Society (acceptancerate top 20%). The proposed project was publicized on UCI website.--Research projects--• Conducted a psychophysical study, investigating the effect of context and interstimulusinterval on short-term memory of visual grating contrast.• Originated and developed a behavioral and neuroimaging (fMRI) study (two main experiments)investigating neural/visuomotor adaptation to reversed visual inputs through prismatic goggles.• Participated in a psychophysical and neuroimaging (fMRI) study investigating the visualphenomena of stereoscopic motion perception in 3-D stimuli and the underlying neural correlatesand mechanisms. Show less

  • Graduate Research Assistant

    Jul 2004 - Dec 2009

  • Lecturer/Teaching Assistant

    Dec 2003 - Aug 2009
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  UC Irvine

  Mar 2010 - Aug 2010

  Jr. Research Specialist

  Independently and collaboratively conducted research in cognitive sciences (subfield in visionscience): initiated ideas, developed projects, collected and analyzed statistical and quantitativedata, investigated and summarized results, fit theories and models, inferred logical conclusions, wrote manuscripts and conference abstracts, presented oral and written reports.

• 

  AcuFocus, Inc.

  Jun 2010 - May 2022

  • IDE study and PMA submission for a class III implantable medical device (IOL):- Develop and Manage two PRO studies in AU and in the US: IRB submission, site initiation, site management, responsible for all documents and clinical affairs- Successfully submitted an original IDE submission and a PMA submission- Drafted and submitted Statistical Analysis Plans- Conducted three Pre-Sub meetings with the FDA on study design proposals- One Q-sub meeting with the FDA on Patient Reported Outcomes (PRO) proposal- Offer data-driven advice to clinical operations- Support study enrollment with data tracking, payment structure setup, clinical procedures and case report forms- Support clinical operations with data monitoring, site communication, site training- Actively monitor data for discrepancies, trends; initiates and manages EDC updates- Perform data analysis, health outcomes research, statistical and table programming; draft table shells• PMA approval of a first-of-its-kind class III medical device (corneal inlay);• PAS study;• EU/Asia post-approval and/or investigational studies;• Hire, train and manage direct report (data analyst); collaborate closely with the internal team and external KOLs, clinical sites, EDC vendor, test equipment vendor Show less • Constructed all data tables, statistical analyses and graphs for an original PMA submission anda Panel Hearing as the principle sponsor statistician. Successfully responded to all FDA inquiriesand helped the company gain FDA approval for a class III device. Collaborated with physicians andregulatory experts. Drafted numerous narratives for the IDE study final reports and hundreds ofdeficiency responses to the FDA.• Contribute significantly to study design, protocol drafting, report writing, study planning, clinicalprocedures, case report forms and SOPs. Provide strategic and statistical inputs to Phase I to IV studies and research projects.• Evaluate and select EDC provider (Medidata, NexTrials, DataFax, ClinCapture). Manage EDCbuild projects, and follow through with database design requests. Draft and review database andedit check specifications.• Health outcomes research, monitor study data to proactively identify problematic areas, noticeable trends. Work closely with the clinical team to find solutions and to ensure data quality before database lock in order to achieve clinical trial success.• Built an analytical and DM team; hire, train and manage direct report Clinical Data Analyst,study assistants or interns, identify and assign projects. Directly under Chief Global Clinical andRegulatory Affairs Officer,• Evaluate, hire and manage external SAS programmers and collaborate with expert statisticians,assign tasks and review outputs, negotiate cost, set budget, time management. Cross-functional work with R&D, medical affairs and quality.• Authored six peer-review publications in top ophthalmology journals. Prepared abstracts and presented 15 conference posters or talks at ARVO and AAOpt, and one at JMP Discovery Summit.• Monitor clinical data and conduct site visits. Present study plans to surgeons and train studycoordinators.• Manage statistical software and budget, electronic testing equipment setup & training forthe company. Show less

  • Director, Clinical Research and Biostatistics

    Mar 2021 - May 2022

  • Sr Manager Biostatistics, Clinical Research

    Feb 2014 - Mar 2021

  • Clinical Research & Outcomes Manager

    Sept 2010 - Feb 2014

  • Consultant

    Jun 2010 - Sept 2010