Boyd Hanson Email & Phone Number

Novato, California, United States

Novato, California

I am spending more time with family, volunteering for humanitarian projects, working on genealogy, writing, and prioritizing some new activities on my To Do list.

Dakar, Senegal

Novato, California

Transformed the BioMetrics Department, including biostatistics, statistical programming, clinical data management, and biometrics planning and oversight, into a department capable of providing biometrics leadership for multiple programs and preparing biometrics deliverables for worldwide marketing applications.-- Recruited personnel and developed organizational structure. After two years the department had grown to 55 individuals, of whom only 7 were with the company when I joined.-- Persuaded senior management to support internal production of biometrics deliverables for pivotal trial and eventual successful submission. (Previous submission work had been outsourced.) Under my leadership, high quality work products were produced by the internal biometrics team on time, even with numerous scope changes, resulting in cost and time savings to BioMarin.-- Revised BioMetrics processes to increase efficiency and strengthen GCP compliance. Revising SOPs, work instructions and associated documents. Creating effective training to assure compliance and efficiency.Supervised production of statistical deliverables for BLA and EMA Marketing Authorization Applications (Vimizim for MPS IVa and Drisapersen for DMD) and three INDs (solid tumor oncology and rare diseases).Established International BioMetrics organization in London office during a one-year expatriate assignment. Integrated newly recruited staff and staff from acquired team into global biometrics department.Developed effective biometrics oncology capability through targeted recruitment, and process development.Enhanced quality of clinical research through participation on Clinical Research and Protocol Review Committees.Strengthened collaboration between Pharmacological Sciences and Biometrics leading to improved data interpretation.

Directed group of 10 biostatisticians primarily focused on oncology, immunology and hemophilia.Continued to direct the non-clinical statistical group located at the Cambridge, MA site.Relocated to San Diego site from Cambridge to increase collaboration of biostatistics with other functions of Oncology R and D. Mission accomplished through my activities and those of the staff under my direction: -- Innovative trial designs developed by statisticians in the group and adopted by clinical development teams; some designs facilitated earlier decisions in clinical programs. -- Enhanced collaboration and effectiveness through better communication and increased delegation, creating more opportunities for staff to make positive contributions to clinical development teams. -- Improved statistical participation on leadership and strategy teams, including Oncology Clinical Review Committee, Oncology Portfolio Committee, Translational Oncology Working Group.Supervised production of statistical deliverables for 2 successful sBLAs and 5 INDs.Increased statistical literacy at the site though statistical training to non-statisticiansAssured efficiency and quality of biostatistical and statistical programming operations.Collaborated on evaluation of data flows to facilitate pharmacometric modeling.Supervised activities of CROs providing statistical deliverables for Phase II and Phase III clinical trials.Recognized as an Exceptional Performer – 2008.

Directed global staff of 25 biostatisticians at three locations working in neurology, oncology, immunology, cardiology.Supervised production of statistical deliverables for a successful BLA, 2 successful sBLAs, and 6 INDs. Extended influence of Biostatistics group through increasing statistical representation on program teams, establishing a non-clinical statistics group, and instituting a statistical group in the UK office.Established and directed non-clinical statistical group, which has contributed to increased effectiveness of non-clinical departments.Assured efficiency and quality of global biostatistical operations. Increased effectiveness through analysis of data flow and communication, implementation of enhanced communication processes, development and implementation of a coordinated outsourcing strategy, implementation of CDISC data standards and standardized statistical outputs.Developed system for tracking status biostatistical activities. Adjusted resources based on shifting corporate priorities; biostatistical teams achieved team deadlines for all statistical deliverables.Supervised the integration of biostatistical processes from former Biogen and IDEC and the preparation of updated SOPs and work instructions. Created new processes to increase efficiency of clinical data analyses.Supervised activities of CROs providing statistical deliverables for Phase I, II, and III clinical trials.Participated on therapeutic area leadership teams for oncology, neurology and immunology.Recognized as an Exceptional Performer – 2007.

Directed preparation of biostatistical and clinical components of an electronic BLA, including serving as a principal co-author of ISS and ISE.Directed preparation and analysis of data from the pivotal clinical trial .Represented Biopure in discussions with FDA and other governmental agencies.Collaborated with Regulatory Affairs to assure timely preparation of required regulatory documents.Directed development of Department of Biostatistics and Data Management.Evaluated CROs for data management and biostatistical activities for new projects.Served as statistical advisor to upper management and board members. Directed statistical activities in support of manufacturing and process technology departments. Provided statistical consulting for marketing and veterinary product groups.

Collaborated with clinical development teams in the in the fields of infertility, growth, metabolic wasting, oncology and multiple sclerosis / immunology. Prepared statistical deliverables and contributed to decisions. Communicated statistical assumptions and results internally and externally.Interacted with regulatory authorities from the FDA in discussions of on-going clinical development plans.Directed statistical programming function of 6 statistical programmers. Recruited and trained additional staff. Developed planning tools to enhance communication and collaboration.Participated on process improvement teams reviewing biostatistical and document management processes and SOPs. Developed action plans and implemented recommendations.Initiated collaboration with non-clinical and marketing functions, improving experimental designs and enhancing interpretation of results.

Collaborated in the design, conduct and analysis of research and development studies of new or existing veterinary pharmaceutical products. Communicated results internally (co-author on 70+ Technical Reports) and externally. Contributed to 11 regulatory filings leading to successful marketing approvals.Developed effective relationships and actively collaborated with scientists in product discovery, development and defense of veterinary pharmaceutical products.Provided training for biostatisticians and other scientists and technicians in statistical concepts and methodologies.Spent 2 months in Belgium office on a job exchange directing clinical operations.

(Note: two years in Rwanda [Central Africa] and one year in Arkansas. Activities in Rwanda were conducted primarily in French and some in the Rwandan native tongue.)Established the Biometrics Unit of ISAR, a research institute of 60 personnel. Trained and supervised staff. Assessed statistical needs of ISAR, and procured and installed computer hardware and software. Collaborated with researchers at ISAR and in agricultural development projects throughout Rwanda to increase the effectiveness of agricultural research through enhanced design of trials and surveys. Provided researchers with training seminars and materials relative to statistical methods and analysis. Developed and taught a graduate level applied statistics course at UArk.Assisted with an organizational audit of the office of International Agricultural Programs at UArk and developed a new organizational plan that was, in principle, adopted and instituted.

Developed and taught (in French) upper division level courses in applied statistics and fish culture.Planned, engineered and supervised construction of the 50 acre UNR fish culture station, including 50 ponds and a limnological laboratory. Supervision included direction of 450 laborers. Prepared successful request for funding of station expansion. Initiated production and research activities at the station, and trained the personnel needed to operate the station and utilize the laboratory. Supervised management of the station. (Note: station is still operating.)

Phd, Statistics

Dissertation examined Qualitative and Quantitive Interaction

Phd, Fisheries

Dissertation examined Lipid Biochemistry of Aquatic Insects

Ms, Statistics

Thesis Topic was Using Analysis of Covariance to Compare Regression Models