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Yyyyyy x. yyyyyy

Xxxxxx, XXXXXX xxxxxx (xxx-xxx-xxxx


Qualifications for Senior Statistical Programmer

Details- and Results-Focused Leader Committed to Maximizing Pharmaceutical / Biotech Industry Results


Dynamic Ph.D. in Psychology Graduate who offers 21+ years of proven experience in rigorous SAS programming, analysis, and support within the pioneering biopharmaceutical industry for Phase 1 4 and multinational studies. Top Performer who contributes solutions-centric critical thinking for insightful, change-oriented results while expertly aligning with an employer s vision, value, and goals. Out-of-the-Box Thinker who rises above research, analysis, and / or project challenges to achieve winning outcomes, including quickly adapting to evolving scenarios via skill with ANOVA, linear / nonlinear regression, factor, cluster, discriminant analyses, modeling, and survival. Excellent Communicator who develops synergistic relationships with key decision-makers, and who leads peers by example and with ethics and integrity.


Core Competencies Include:

  Exhibiting recognition as a quick study who rapidly picks up new concepts.

  Demonstrating expertise in SAS / BASE (including MACRO), STAT, and GRAPH.

  Actively upholding cutting-edge technical talents and up-to-date trends awareness.

  Offering research, experimental design, hypothesis testing, and statistical analysis skills.

  Collaborating with cross-functional peers to deliver quality-focused SAS support / analysis.

  Providing hands-on support always willing to go the extra mile to surpass the status quo.




Ph.D., Psychology (Statistics & Research Emphasis) University of Virginia, Charlottesville, VA

M.A., Psychology (Statistics & Research Emphasis) University of Virginia, Charlottesville, VA

B.A., Psychology University of Colorado, Boulder, CO


Macro Language Advanced Programming Color Graphics SAS Institute, Rockville, XXXXXX


Professional Synopsis


Chiltern International, King of Prussia, PA (2016 Present)


Therapeutic Area / Indication

Dermatology Epidermolysis Bullosa (Phase 3-4, Open Label Extension, Multi-Site Global)

Pre-Term Pre-Eclampsia (Phase 3, Multi-Site North America) Leukemia (Phase 1, Multi-Site USA)

Medical Devices (Phase 4, Global Post-Marketing) Psoriasis (Phase 1b, Multi-Site North America)

Oncology (Phase 1-3, North America, Europe & Asia) Psychiatric ADHD (Phase 2, Multi-Site USA)

Diabetes Types 1 & 2 (Phase 4, Post-Marketing, Multi-Site USA) Cystic Fibrosis (Phase 2, USA & Europe)

Anti-Infectives C. difficile (Phase 2b, Multi-Site USA & Canada) Ophthalmology (Phase 2a, Multi-Site USA)


Lead Statistical Programmer Analyst

Capitalize on the opportunity to lead forward-thinking SAS programming of simultaneous clinical studies for diverse indications, including areas of Oncology, Neurology, Cardiovascular, Immunology, and Dermatology, among others. Develop CDISC-compatible SAS datasets of clinical data from clinical databases, create safety and efficacy datasets and project-specific macros and formats, load client data from other platforms and software packages, and prepare data to be sent to clients. Expertly program customized data displays (i.e. data listings, summary tables, figures) to comply with approved statistical analysis plans and shell displays for clinical research studies (code is written using Base SAS Programs, SAS Procedures, SAS Stat, SAS Graph, and Standardized Macros). Prepare comprehensive documentation describing all datasets and variables within, as well as detailing project and / or program initiatives. Lead targeted data checks to ensure the integrity and accuracy of data displays.



Yyyyyy x. yyyyyy Page Two (xxx-xxx-xxxx


Professional Synopsis (continued)


GlaxoSmithKline, Philadelphia, PA (2014 2015)


Therapeutic Area / Indication

Autoimmune Disorders (Lupus) (Phase III, Multi-Country)


Senior SAS Programmer Contractor

Strategically steered development and validation of SDTM and ADAM analysis data sets using CDISC standards for Benlysta, and produced specs for SDTM and ADAM analysis data sets used to create CDISC-compatible data sets. Defined and developed analysis / reporting and aggregated data sets for Integrated Summary Efficacy / Safety reporting. Continually ensured optimal delivery of submission-ready data.


AstraZeneca, L.P., Wilmington, DE (2002 2003 2004 2006 2010 2014)


Therapeutic Area / Indication

Respiratory (Phase 3-4, Multi-Country) Cardiovascular (Phase 2-3, Multi-Country)

Neuroscience (Phase 2-3, Multi-Country) Psychiatric Depression (Phase 2-4, Multi-Country)


Senior Statistical Programmer Consultant (2010 2014)

Utilized broad scope of industry knowledge toward producing and validating tables, listings, figures, SDTM, and ADAM analysis data sets using CDISC standards, as well as ad hoc requests, for a Neuroscience Division.


Senior Statistical Programmer Consultant (2004 2006)

Produced tables, listings, figures, and SAS analysis data sets from specifications provided by statistician for a Quantitative Decision Sciences Division. Handled programming and statistical support for Zomig and Seroquel protocols within the Neuroscience Department. Performed univariate and nonparametric statistical methods, including Chi-Square, ANOVA, Regression, Cochran Mantel-Haenszel, Kaplan-Meier Survival Analysis.


Statistical Programmer Consultant (2002 2003)

Optimized production of Clinical Study Reports by providing integral analytic support to biostatisticians, including integrating summaries of safety and efficacy and performing ad hoc analyses for studies of Central Nervous System and Cardiovascular disorders. Supported statistical programming for critical FDA responses on inquiries in preparation for an Advisory Committee Meeting for Crestor. Reviewed detailed statistical analysis plans. Developed or enhanced standardized macros and utility programs. Used SAS / GRAPH.


Chiesi Pharmaceuticals, Inc., Rockville, XXXXXX (2009 2010)


Therapeutic Area / Indication

Cystic Fibrosis (Phase III / Phase IV, Multi-Country)


Senior SAS Programmer Consultant

Spearheaded development and validation of SDTM and ADAM data sets, including ISS and ISE pooled datasets, for electronic submission following CDISC guidelines. Effectively created safety and efficacy tables, listings, and figures and defined documentation per specs set forth in protocols and statistical analysis plans.


Octagon Research Solutions, Inc., Wayne, PA (2007 2009)


Senior SAS Programmer Consultant

Drove research solutions success by programming and validating safety and efficacy tables, listings, and figures. Developed SDTM, ADAM, and ISS pooled analysis data sets in CDISC format. Demonstrated skill in performing comprehensive statistical analyses, including GEE, GLM, and Monte Carlo simulations.


Amgen, Inc., Thousand Oaks, CA (2007)


Senior SAS Programmer Consultant

Efficiently produced comprehensive tables, listings, figures, and SDTM and ADAM analysis data sets. Developed and validated SAS macros that were written to automate and expedite key standardized processes.



Yyyyyy x. yyyyyy Page Three (xxx-xxx-xxxx


Professional Synopsis (continued)


Synteract, Inc., Carlsbad, CA (2006)


Senior SAS Programmer Consultant

Collaborated with a top-notch statistician to develop and validate tables, listings, figures, and analysis data sets. Offered skill in Survival Analysis, Logistic Regression, T-Test, Fisher s Exact Test, and Kaplan-Meier Curves.


Pfizer, Inc., New London, CT (2003 2004)


Therapeutic Area / Indication

Osteoporosis (Phase III / Phase IV, Multi-Country)


Senior Statistical Programmer Consultant

Exhibited talent in producing listings, tables, figures, and SAS analysis data sets from specifications provided by statistician. Skillfully used Mantel-Haenszel Chi-Square, Fisher s Exact Test, ANOVA, and Logistic Regression statistical methods. Prepared an electronic submission for a compound to prevent Osteoporosis.


Purdue Pharma, L.P., Stamford, CT (2002)


Therapeutic Area / Indication

Pain Management (Phase III / IV, Multi-Country)


Senior Statistical Programmer Consultant

Recognized as the lead programmer for the company s highest-priority project, Palladone a morphine-based compound for severe chronic pain management. Delivered statistical programming support for the development and validation of analysis datasets, tables, listings, and figures for study reports, including ISS pooling. Reviewed Statistical Analysis Plan, Case Report Form, database, and edit specifications design.


MedImmune, Inc., Xxxxxx, XXXXXX (1998 2001)


SAS Programmer Clinical Data Analyst

Expertly designed, coded, tested, and ran SAS summary tables, listings, and graphs for 20+ protocols for inclusion within clinical study reports, including reviewing study protocols, statistical analysis plans, table / listing templates, case report forms, edit specifications, and Oracle Clinical database structure. Contributed skill in extracting data from Oracle Clinical Database and manipulated data to create analysis SAS datasets. Validated SAS programs written by programmers and biostatisticians. Conceptualized, developed, and disseminated the first draft of new companywide SAS programming and validation standards.


Globomax, LLC, Hanover, XXXXXX (1998)


SAS Programmer Analyst Consultant

Generated tables, listings, and graphs for key Phase I studies. Led Pharmacokinetic Analysis using WinNonlin.


Boehringer Mannheim Corporation, Xxxxxx, XXXXXX (1997 1998)


SAS Programmer Analyst Consultant

Led data transfer of a multi-center / multi-protocol study for Congestive Heart Failure, including facilitating data cleaning, mapping of programs and datasets, and transferring of data files through FTP software from VAX mainframe to PC, as well as writing technical documentation to accompany data transfer. Drafted QA programs to assess the integrity of data transfer. Processed ad-hoc data requests, including mapping request concepts to specific variables on SAS datasets, writing QA programs to validate SAS data, writing SAS programs to generate output, and communicating among essential parties. Demonstrate proven experience in SAS BASE / MACRO and STAT on a VAX / VMS and / or a PC / Windows 95 platform.


Excellent Professional References Provided Upon Request


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