yyyyyy x. yyyyyy
veteran preference: no
ssn: 0000 xxxxxx xxxx , xxxx , xxxxx 00000 edenwilde drive
roswell, ga 30075
evening phone: 770-569-0723
daytime phone: 770-970-8630
us citizen, statistical analysis plan development, advice, strategy and consulting. clinical trial design, simulation and monitoring, adaptive statistical methodologies, report review, statistical programming using sas, analysis interpretation, statistical report authorship and review, exploratory analysis, statistical representation and presentation to regulatory authorities, regulatory compliance, statistical methodology review, modeling and simulation, adaptive designs, development and implementation of sops, good clinical practices. maintains professional membership with the american statistical association.
associate director biostatistics. 04/06-present
40 hours per week. $148,000 annually.
usb inc. / schwarz biosciences inc.
supervisor: john doe, 555-555-1212. permission to contact: no
data analysis and interpretation: employ strong analytical and exploratory skills to efficiently analyze and interpret clinical trial efficacy and safety data. develop and author statistical analysis plans and strategies for individual clinical studies and integrated summaries for regulatory submissions. conduct exploratory statistical analyses using reliable modeling techniques designed for long term observational, clinical data.
leadership and team management: effectively lead an international team of statisticians and programmers to complete a vital pediatric regulatory submission in support of a patent extension for a key company product. manage, mentor and advise biostatisticians based in atlanta; direct statistical analysis activities for varied drug development projects, provide statistical support and expertise during design and analysis phases of clinical development programs and clinical studies to ensure protocols and analytical strategies are statistically sound and scientifically valid. ensure consistent implementation of appropriate and highest quality study protocols and methodologies across all studies. provide statistical advice and expertise including interpretation, reporting and publication of analysis results during multiple project phases. render statistical support for regulatory submission activities and represent biostatistics in discussions with regulatory authorities. assist efforts of the global statistical team leader to complete resources estimations and conduct budget management activities.
principle biostatistician / biostatistics manager. 12/03-04/06.
40 hours per week. $120,000 annually.
supervisor: jane doe, 555-212-1212.
permission to contact: yes
project management: provided ongoing statistical expertise and support for a primary cystic fibrosis clinical development program. served as principal statistician for an asthma clinical development program. conducted statistical research pertaining to methods evaluation for specific study related endpoints and objectives. estimated and projected departmental resource requirements. utilized strong public speaking and presenting capabilities to present clinical trial findings to appropriate company representatives. developed and conducted simulations to evaluate respective drug supply shipping mechanisms for varied clinical trials resulting in significant reductions in operation costs for the company.
consultation: consulted and advised for use of statistical analytical methodologies relevant to study protocols and statistical analysis plans. developed integrated analysis plans for regulatory submissions.
project leadership: led a cross-functional team in the formulation of standardized statistical reporting methods. led and managed staff of three biostatisticians. led department in the development and implementation of standard operating procedures (sop) and standardized working practices.
senior statistician. 05/02-11/03.
40-50 hours per week. $105,000 annually.
supervisor: jim ward, 555-212-1212.
permission to contact: yes.
project management: provided strategic statistical support for varied clinical development programs. developed and presented clinical trial design plans and analysis strategies to optimize project efficacy. managed, coordinated and led statistical functions of respective contract research organizations and internal sas programmers. employed organizational and leadership skills to successfully establish and supervise high functioning and effective data monitoring committees and corresponding charters. provided statistical representation and presented at fda meetings.
consultation: contributed ongoing counsel and support during establishment of product go/no-go stopping rules.
fiscal management: determined project parameters and financial resources required to meet objectives, developed, implemented and managed comprehensive budgets for each clinical trial.
authorship and presentation: authored statistical analysis plans and statistical methods sections for protocols and clinical study reports. authored and co-authored departmental sops. analyzed clinical trials data and presented results to senior management.
senior statistician/statistician/associate statistician. 08/92-05/02.
40 hours per week. $82,000 annually.
research triangle park, north carolina
supervisor: gilda womble, 555-212-1212.
permission to contact: yes.
program support and management: provided strategic statistical support for phase ii and iii neurology and psychiatry clinical development programs; consulted and advised for study design, endpoint selection, and comprehensive analysis strategies. collaborated with senior level staff from clinical, commercial and regulatory organizations to address, discuss and review key developmental issues and topics.
developed data analysis plans and statistical methods section for study protocols.
authorship/presentation: co-authored final study reports and manuscripts for journal publication. presented statistical strategies to development team and programming techniques to department staff.
statistical analysis/interpretation: analyzed and interpreted clinical trials efficacy and safety data and managed and coordinated completion of statistical projects for antiemesis, cns, phase ii oncology and multiple phase i projects. developed sas programs to conduct statistical analyses and produce statistical tables, figures and listings. trained and supervised summer interns, oversaw work activities of contractors.
statistician, gs-11-1530. 04/89-08/92
40 hours per week. $33,504 annually.
us department of defense
naval aviation depot
supervisor: percy grays, 555-212-1212.
leadership and program managment: served as depot representative for the dod performance management system and directed the productivity gain sharing program. coordinated comprehensive aspects of multiple research projects design to determine depot productivity, performance, cost trends and variances. directed statistical data gathering and analysis activities. initiated, developed, and maintained statistical process control charts for multiple administration and production areas and teams.
presentation and reporting: presented study conclusions and provided detailed reports to senior level management. coordinated and prepared extensive statistical and graphical presentations for senior level management.
agricultural statistician, gs-07- 1530. 04/88-04/89
40 hours per week. $19,493 annually.
us department of agriculture
national agricultural statistics service
sacramento/athens, ca and georgia
supervisor: robert hettinger, 555-212-1212.
permission to contact: yes.
leadership/survey planning: planned and coordinated agricultural surveys; statistician-in-charge for the 1989 commercial horticulture specialties survey and the 1988 aquaculture survey. supervised and coordinated survey enumerators. reviewed and edited survey questionnaires to ensure accuracy, consistency, and reliability of data. prepared survey evaluations. developed new and modified existing sas programs for data summarization and analysis. initiated and maintained communication with industry and local government personnel.
university of north carolina, chapel hill, nc
master s degree in biostatistics, minor: epidemiology, 05/1996
relevant coursework: probability & statistical inference i & ii, intermediate linear models, sample survey methodology, advanced techniques biometry, analysis of categorical data, introduction to applied statistics, principles of statistical consulting, principles of epidemiology, cancer prevention & control, clinical trials epidemiology
university of georgia, athens, ga
bachelor of science degree, statistics, 03/1988
relevant coursework, licensure and certificates: statistical methods i & ii, probability theory, statistical theory i, statistical computation, applied time series, applied stochastic processes.
mixed models for longitudinal analyses, 2009
adaptive designs, 2007
effective coaching and feedback, 2006
the seven habits of highly effective people, 2006
survival analyses, date
effective influencing and negotiations, date
advanced linear models (sas), date
advanced sas programming, date
sas programming, date
awards and recognition
silver spot award for exemplary performance, ucb, 2009.
how many ? spot awards, ucb & glaxosmithkline, dates
demonstrated expertise in sas programming, from what entity and date.
publications and presentations
adjunctive levetiracetam in infants and young children with refractory partial-onset seizures co-authored with je pina-garza, et. al. (epilepsia e-pub 2009; doi: 10.1111/j.1528-1167.2008.01981.x).
sitaxsentan therapy for pulmonary arterial hypertension co-authored with rj barst, et. al. (american journal of respiratory and critical care medicine, 2003; 169:441-447).
random simulation methods for computing power and sample size for tukey s trend test. presented at the pharmaceutical sas user s group meeting in seattle, wa, may 8, 2000. manuscript published in the proceedings.
lack of effect of cimetidine on the pharmacokinetics of sustained-release buproprion. co-authored with r kustra pharmd, et al. (journal of clinical pharmacology, 1999;39:1184-1188).
a comparison of the efficacy, safety, and patient satisfaction of ondansetron versus droperidol as antiemetic therapy for elective outpatient surgical procedures. co-authored with jt fortney md, et al. (anesthesia & analgesia, 1998;86:731-738).
bioequivalence of combivir tablet and epivir plus retrovir tablets. abstract co-authored with khp moore, pharm.d., et. al. in: program and abstracts of the 5th conference on retroviruses and opportunistic infections. february 1-5, 1998, chicago, il.
controlling for experimentwise type ii error: optimum patient allocation for a three armed, parallel, randomized, controlled clinical trial with binary outcomes. presented at the pharmaceutical sas user s group meeting in hilton head, sc, may 12, 1997. voted best paper.
statistics/pharmacokinetics section. manuscript published in the meeting proceedings.
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