Biometrics Manager

  • Accomplished professional with over fifteen years’ experience in Data Management and Statistical Programming
  • Possess strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat
  • Spearheaded full Biometrics team for one filing
  • Led two filings as CDM representative and significantly contributed to two other filings as Clinical Programmer
  • Subject management expert in oncology report, lab data, durg dictionary recoding and co-op studies
  • Adept at designing, developing, evaluating and modifying computer programs to analyze and evaluate clinical data to generate study specific and ad-hoc clinical data listings, summary tables and figures
  • Demonstrated ability to use professional concepts to achieve objectives in creative and effective ways
  • Hands-on experience in the analysis of complex oncology clinical trial data as well as solid knowledge of CDISC standards (SDTM & ADaM)


Manager, Clinical Data Management

Genentech South San Francisco, CA 2016 – Present

  • Manage up to nine direct reports, including Study Data Managers, SAS programmers for SDTM mapping, Rave builders and Data Acquisition Specialists

  • Spearhead the data table used to respond to the FDA for a site inspection finding, engineering the solution and validating the output while reducing timelines by one week

  • Manage CDM tools and processes for non-CDISC filings to be used for over eight filings in 2017

  • Perform resource manager duties for 40+ studies, editing demand and projections on PlanSource (Human Resources system) to balance vendor and full-time headcount

Manager, Clinical Programming

Roche | 2014 –2016

  • Managed a combination of Study Data Managers, Data Acquisition Specialists and Clinical Programmers

  • Supervised two rotations within the department, one for project management within Clinical Programming Reporting and another for ClinicalProgramming Transformation

  • Lead team of programmers for support of CDISC and non-CDISC deliverables

  • Introduced projects for automation of SDTM bookmarking and mechanization of vendor-data type searches

Interim Manager

Roche | 2013 – 2014

  • Managed global resourcing for Transformation for both Roche sites and FSPs

  • Collaborated with gRED Operations for data reporting of clinical data

  • Managed two DDE concurrent filings by establishing contracts with a vendor, coordinating the creation of SDTM datasets, collating information for the eSub group, and producing annotated CRFs

  • Took ownership of patient profile and narrative tracking sheet creation for Safety Science, Clinical Science and narrative writers to ensure global alignment of work practices

Principal Clinical Programmer

Roche | 2013

  • Directed the training of SSF reporters in the Hyperion tool for data cleaning reports and narrative writing, and created data listings for the GOG filings that led to additional indication approval

  • Trained 20 staff members across SSF and Inventive in RECIST (Response Evaluation Criteria in Solid Tumors) to better support Operations and Clinical Science

Senior Clinical Programmer

Roche/Genentech | 2006 – 2013

  • Programmed listings for two of the initial bridging studies, which became the template for integrated Roche and Genentech Data Management processes

  • Led the CLEAR project for both OCL and EDC (versions 2.0, 2.5 and 3), facilitated the development and QC of reports and aided in trouble shooting of SAS IntRnet code

  • Supported the Kadcyla filing as sole Clinical Programmer on pivotal trial (TDM4370)

  • Piloted edit checks for the co-op study GOG0218 to assess and later ensure quality of third-party data

  • Represented SSF Data Management in the Genentech Medical Data Review Initiative, harmonized reports for Clinical Science

  • Provided input to the Migration Working Group, led the creation of the SAS comparison report

  • Created learning materials and carried out train-the-trainer sessions for the use of the SAS comparison report which was ultimately utilized by the whole CP-Build group

Clinical Programmer (Contract then permanent)

Genentech | South San Francisco, CA | 2005 – 2006

Clinical Programmer (Contract)

Gilead Sciences | Foster City, CA, | 2004 – 2005





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Johns Hopkins University, Baltimore, MD

Masters in Health Science, Public Health

University of San Francisco, San Francisco, CA

Bachelor of Science, cum laude