Provide statistical input and support for clinical trial design, conduct, data analysis, and results interpretation.

Lead Biometrics Submission Team for NDA.

Act as a core member of clinical study teams.Ensure adherence to industry standards and regulatory requirements.

Defend the study designs and analyses to regulatory authorities when required.

Provided strategic input into the clinical development plan for CPI-444.

Provided ongoing statistical expertise as the Statistician on the cross-functional team for a Phase I/Ib study of CPI- 444 for patients with selected incurable cancers. 

Oversaw Contract Research Organization (CRO) statisticians in development of statistical analysis plan.

Collaborated with statistical programmers to prepare specifications and SAS programs for analysis data sets, report tables, listings, and graphs for ongoing analyses and final study report.

GENENTECH, INC.                                                                                                                                        2008 - 2016

Senior Statistical Scientist  (03/13 – 10/16) 

Statistical Scientist  (07/08 – 02/13)

Served as the Project Lead Statistician (PLS) on 4 cross-functional project teams (4 molecules in multiple therapeutic areas including asthma/allergy, rheumatoid arthritis and dermatology).

• Late-Stage Clinical Subteam for early clinical development project - providing strategic input into the clinical development plan and target product profile to accelerate development of key pipeline asset.
• Lebrikizumab Global Development Team – providing statistical leadership for closeout activities of ongoing asthma studies.
• Xolair Global Development Team - served as Biostatistics lead for Health Authority interactions and provided statistical input for clinical development plan.

Assisted with preparing multiple responses to FDA questions and requests.

Participated in meetings with the FDA resulting in key updates to the Xolair label; one new indication and important results from a post-marketing study.

Ensured statistical rigor in clinical development plan for a potential new Xolair indication and participated in meeting with FDA to discuss adequacy of the plan for potential approval; resulted in altered Genentech strategy for pursuing new indication.

• Quilizumab Early Development Subteam – provided statistics expertise and strategic input regarding potential transition of molecule from early to late stage after Phase II study readout.

Led the global Biometrics Submission Team for the lebrikizumab asthma BLA/MPAA filing, team of 20 individuals.

• Developed proposals for the scope, format and content of the Biometrics components of the submission.

Gained endorsement of full team and enabled initiation of submission package preparation prior to readout from pivotal trials. Thus ensuring timelines were met.

• Coordinated with other functions on the Global Filing Team to identify and plan for Biometrics support for other components of the submission.
• Collaborated with functional management to ensure adequate resources to achieve on-time delivery of the Biometrics components.

Provided ongoing statistical expertise as the Study Lead Statistician for Phase II to Phase IV studies across three molecules for asthma and chronic idiopathic urticaria (CIU) indications. Ensured the statistical integrity, adequacy, and accuracy of the clinical studies supporting global filings.

Xolair:

• Led cross-functional protocol analysis and reporting team (PART) for a prospective observational cohort study of long-term safety of Xolair treatment for moderate-to-severe asthma (EXCELS study)

Performed statistical analyses, generated tables and figures and wrote four annual interim study reports (ISR) and the final clinical study report for submission to the FDA.

Resulted in FDA confirming fulfillment of post-marketing commitment and accepting suggested updates to the Xolair label.

• Created statistical analysis plans and collaborated with statistical programmers to prepare specifications and SAS programs for analysis data sets, report tables, listings, and graphs for the Xolair post-marketing pregnancy registry, a Phase III Xolair CIU study and the Summary of Clinical Safety for the Xolair CIU global filing.
• Performed statistical analyses including Cox regression, propensity score analysis, ANCOVA and mixed models with repeated measures (MMRM).
• Provided statistical support during protocol development, eDiary development and IVRS development for all three Phase III CIU studies.
• Provided statistical methodology and results sections for peer-reviewed manuscripts.

Lebrikizumab:

• Provided expert biostatistical support:

Performed statistical analyses including Cox regression, Poisson regression and MMRM.

Executed exploratory analyses to assist in the evaluation and interpretation of results from two pivotal lebrikizumab asthma studies.

• Prepared statistical analysis plans and specifications for report tables, listings, and graphs for the Summaries of Clinical Efficacy and Safety for the planned lebrikizumab asthma filing.

Quilizumab:

• Prepared statistical analysis plans and specifications for report tables, listings, and graphs for two Phase II quilizumab studies. 
• Performed statistical analyses including Poisson regression and ANCOVA.
• Provided statistical methodology and results sections for peer-reviewed manuscripts.

Represent and support the Biostatistics department in our role as strategic partners in drug development.

• Contributed to cross-functional due diligence team for a prospective in-licensing.

Reviewed existing clinical data and reports for a potential asset.

Performed additional analyses to aid team in evaluating the asset and developing recommendation.

Analyses results were included in presentation to internal review committee to support recommendation.

Received positive team feedback on clarity and helpfulness of my assessment to decision-making.

• Represented Biostatistics on the cross-functional team tasked with developing data collection and data structure standards for future asthma studies.
• Designated mentor for a statistician who is new to industry and informal mentor for two additional statisticians who were new to late stage development. 

MEDFOCUS, LLC.                                                                                                                                     2006 - 2008

Biostatistical Consultant

Provided statistical consulting support to Genentech as Lead Statistician for EXCELS study, a post-marketing commitment to the FDA.

• Collaborated with statistical programmer to prepare specifications and SAS programs for analysis data sets, report tables, listings, and graphs.
• Performed statistical analyses, generated tables and figures and wrote 2 ISRs for submission to the FDA.
• Assisted in responding to two FDA inquiries regarding the study design and the statistical analysis plan.
• Presented study status updates and the importance of patient retention at two Investigator Meetings.

QLT, INC.                                                                                                                                                    2001 - 2006

Senior Biostatistician

Acted as a core member of multiple clinical study teams providing statistical input and support related to clinical study design and conduct, data analyses and results interpretation across multiple therapeutic areas including oncology, dermatology and ophthalmology.

• Provided statistical input to four clinical trial protocols with respect to the study design, study objectives, endpoints, sample size, stratification and randomization.
• Wrote and implemented five statistical analysis plans including:

QC of tables, listings and graphs generated by statisticalprogrammers

Statistical analyses for oncology studies using Cox regression, log rank tests and Kaplan-Meier methods to evaluate overall survival and progression-free survival and evaluation of objective response using Mantel-Haenszel tests.

Statistical analyses for non-oncology studies including t-tests, chi-squared tests and ANCOVA.

• Wrote methods and results sections for five clinical study reports.

QUINTILES, INC.                                                                                                                                      1997 - 2001

RESEARCH TRIANGLE INSTITUTE                                                                                                 1996 - 1997

Statistician