In my current role, I oversee biometrics for the entire Oncology portfolio, across early and late development stages, encompassing statistics, programming, statistical innovation, data science, and information science teams. Our department is accountable for the design, delivery and interpretation of clinical trials, regulatory activity, and innovation including data science support. I am also a member of the Therapeutic Area Leadership Team and other governing bodies across the Oncology Business Unit.
I have been with AstraZeneca for nearly 20 years and in that time have been dedicated to innovating clinical trials in oncology – from emerging products to Phase III development plans.
This is an exciting time at AstraZeneca. Innovative technologies are allowing us to better capture and harness data, and enabling us to better understand diseases, identify new targets, and recruit for and design clinical trials. We are able to more efficiently analyze, interpret and apply data, maximizing the discovery and delivery of potential new medicines.
Our team has expanded with the growth of our Oncology portfolio. I am proud of the role I have played in the professional development of our staff and in mentoring colleagues.
I have authored and co-authored 20 papers, 20 abstracts for cancer research conferences, and have spoken at cancer meetings and conferences on topics including progression-free survival, biomarkers, pharmacogenetics and trial designs for early oncology. I have served on external cross pharma statistical initiatives such as Cross PhRMA Progression-Free Survival Working Group and currently co-chair a working group looking at Effects of Non Proportional Hazards on Trial Design and Analytical Methods. I am a member of the American Society Clinical Oncology, Pharmaceutical Users Software Exchange, American Statistical Association and the Healthcare Businesswomen’s Association. I also serve on the Board of Vanderbilt University’s Graduate School for Basic Sciences
I earned a PhD in pathology and a Master’s in Public Health from Vanderbilt University, and a Bachelor of Science in Biology from the University of Tennessee at Martin, in Martin, Tennessee.
I’m very excited about the work we are doing at AstraZeneca: we’re using the power of data design and management, technology and statistical methods to better understand diseases and inform the design and analysis of clinical trials. Improving the design and productivity of clinical trials and our use of AI and other technologies to gather and analyze large quantities of data will enable us to bring better medicines to people with living cancer.
Held senior leadership roles in Biometrics & Information Science for AstraZeneca Pharmaceuticals, first as Head of Alliances and Operations Office for the newly-established department, then as Senior Director, Oncology Biometrics Head, with focus on late stage delivery (Phase III and regulatory submissions)
As Section Director, Statistics and Programming, managed teams in the Wilmington, Delaware and Sodertalje, Sweden locations for AstraZeneca Pharmaceuticals
Represented Clinical Information Science for the Global Clinical Learning and Development Team as Director of Statistical Science of Oncology for AstraZeneca. Served as a core member of Phase I Oncology Initiative team, Global Lead for Biostatistics Training and Development and member of Global Personalized Medicine Team
Alternative Analysis Methods for Time to Event Endpoints Under Nonproportional Hazards: A Comparative Analysis
Lin RS, Lin J, Roychoudhury S, Anderson KM, Hu T, Huang B, Leon LF, Liao JJZ, Liu R, Luo X, Mukhopadhyay P, Qin R, Tatsuoka K, Wang X, Wang Y, Zhu J, Che TT, Iacona R & Cross-Pharma Non-proportional Hazards Working Group. Stat Biopharm Res. 2019 Dec;12(2): 187-198. https://doi.org/10.1080/19466315.2019.1697738
Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group
Stone AM, Bushnell W, Denne J, Sargent DJ, Amit O, Chen C, Bailey-Iacona R, Helterbrand J, Williams G. European J Cancer. 2011 Aug;47(12):1763-71. https://www.ejcancer.com/article/S0959-8049(11)00110-9/fulltext
Epidermal growth factor receptor expression analysis in chemotherapy-naïve patients with advanced non-small-cell lung cancer treated with gefitinib or placebo in combination with platinum-based chemotherapy
A Genomic Search for Alzheimer’s Disease Genes. In Alzheimer’s Disease: Advances in Etiology, Pathogenesis and Therapeutics
Haines JL, Bailey LR, Grubber JM, Hedges D, Hall JL, West S, Santoro L, Kemmerer B, Saunders AM, Roses AD, Small GW, Scott WK, Conneally PM, Vance JM, Pericak-Vance MA. A Genomic Search for Alzheimer’s Disease Genes. In Alzheimer’s Disease: Advances in Etiology, Pathogenesis and Therapeutics. Iqbal K, Sisodia SS, Winblad B (Eds.), John Wiley & Sons, Ltd., New York. 33-43. 2001. https://doi.org/10.1002/0470846453.ch4
History of breast-feeding in relation to breast cancer risk: a review of the epidemiologic literature.
Identification of novel genes in late-onset Alzheimer’s Disease
Pericak-Vance MA, Grubber J, Bailey LR, Hedges D, West S, Santoro L, Kemmerer B, Hall JL, Saunders AM, Roses AD, Small GW, Scott WK, Conneally PM, Vance JM, Haines, JL. Exp. Gerontol. 2000 Dec;35(9-10):1343-52. https://doi.org/10.1016/S0531-5565(00)00196-0