Microsoft word - 4 - zookle sample profile - pharma statistics.doc

Claire Fisher

A dynamic lead statistical programmer experienced in pharmaceutical analysis with both
meticulous and highly creative ability. With an information technology background, I have
worked for both pharmaceutical and contract research organizations, bringing structured
and streamlined coding practices to the discipline of SAS programming.
July 05-present LEAD PROGRAMMER Novaceutical Industries, Dublin
A leading force in the clinical research arena, with in-house biometricians and field-based consultants engaging in ever more chal enging research programmes for a growing portfolio of international y-based pharmaceutical clients.
Main Responsibilities:

• Output development using CDARS, Pfizer’s global reporting system. • Creating plasma concentration and pharmacokinetic parameter tables, listings and figures • Quality control programming to double-check frontline adverse event programs and the associated numbers contained within clinical reports and outputs. • Teaching the art of structured program development and informative commenting to Key Achievements:
• Achieving tight deadlines whilst working both at site and remotely (across countries) • Understanding the basic essentials of CDARS and putting that knowledge into practice Successful y teaching junior SAS programmers highly developed and organized coding
March 03-June.05 PHASE II-IV STUDY COORDINATOR, PharmaTwoCo, London
An innovative outsourcing service specifical y designed for clinical research customers. The company was initial y designed to work directly alongside DEFPharma but, after building a solid reputation in the industry, outsourced work from several other reputable pharmaceutical
Main Responsibilities:
• Coordinating resource for Phase II to IV project work. • Project forecasting and timeline development. • Migratory dataset transfer programming between VAX and Unix. • Creating uniform adverse event datasets from over 130 studies to be incorporated into a combined dataset from which tables and graphs could be generated for client evaluation. • Creating and forwarding adverse event flat files to Data Management for event coding Key Achievements:
• Seeing the extensive growth of Phase II to IV capacity within my time at Satel ite. • Successful y overcoming data standardization issues including conflicting dataset designs • Successful y teaching SAS graduates highly developed programming techniques and
Apr. 01–Feb. 03 SAS PROGRAMMER, A.N.PharmaCorp, London
One of the largest pharmaceutical companies in the world.
Main Responsibilities:
• Developing the prototype software for HARP, the new global reporting system for • Managing a team in a microbiology submission for FDA analysis. • Creating permanent datasets for table, listing and graph production. • Statistical table and listing production. • Creating temporary ad-hoc datasets to be used for graph plots. • Quality control programming to double-check frontline programs. • Creating transport files to be sent to the FDA for tracking purposes.
Key Achievements:
• Seeing the HARP software being implemented by A.N.PharmaCorp on a global basis. • Successful y leading a microbiology FDA submission. • Successful y developing MACRO programs to create tables, listings and graphs for • Consistently achieving tight deadlines throughout my time at A.N.PharmaCorp.
One of the largest Contract Research Organisation (CRO) worldwide, covering al aspects of the pharmaceutical industry except for drug manufacture.
Main Responsibilities:
• Frontline programming to create analysis files. These files were created by converting raw datasets into manipulated derived datasets for final statistical analysis. • Liasing with individuals in Data Management to clarify data coded errors and queries. • Creating datasets to be used for graph plots. • Quality control programming to double-check frontline programs. • Creating supplementary reports and listings for patient tracking purposes.
Key Achievements:
• Successful y developing MACRO programs to create tables, listings and graphs for client review, customising the programs according to client specifications. • Consistently achieving tight deadlines throughout my time at Quintiles.
A mid-sized Dutch pharmaceutical company that dealt with al aspects of the pharmaceutical
Main Responsibilities:
• Paral el programming on existing tables and listings with a view to identifying coding • Producing tables for ad-hoc requests from statisticians to further explore main study • Resolving queries from statisticians regarding logic used in main tables via discussion with table programmers. In other words, the handling of missing or inconsistent data. • Producing summary reports across families of tables so that the effect of late data changes on study results can be tracked and reported to medical writing. • Producing listings for inclusion in the submissions as paper copies for EU purposes or
Key Achievements:
• Successful y constructing high-quality MACRO programs to streamline quality control checks in order to check data validity. This process enabled quick transfer between departments, resulting in tight deadlines being achieved. Professional Training
2000 - Java Introductory Programming Course (London)
1999 - SAS Macro Programming Course (London) 1996 - AED (Audio Engineering Diploma): Audio Applications – S.A.E. (London) 1995 - BSc.2 (i .) Honours: Information Technology – Oxford University Specific Pharmaceutical Knowledge
Current study:
• Pharmacokinetics (Drug: PF-02393296) • Phase III/IV COPD and Asthma studies (Drug: Salmeterol) • Phase I/II Metastatic Soft Tissue Sarcoma study (Drug: Brostal icin) • Phase II/III Breast Cancer study (Drug: Exemestane) • Phase IV Intima-media thickness inhibitor study (Drug: Avandia) • Phase IIa Lp-PLA2 [stenotic plaque] inhibitor study (Drug: SB-480848) • Phase II Schizophrenia study (Drug: Talnetant) • Cardiovascular (Avandia/SB-480848/Refludan) • Psychiatry (Talnetant/Vilazodone/Paxil/GW353162) • Arrays, tables, listings, graph plotting • SAS STAT (NPAR1WAY (p-values), LIFETEST (response survival times), LOGISTIC • Study coordinator at Satel ite. This included stabilizing Phase II to IV resource for the fluctuating intake of new workload as wel as forecasting any potential al ocation issues that • Project leader at Satel ite. The main objective was to lead the programming initiative for a combined integrated safety directive for ATRH’s main competitive respiratory drug in COPD/Asthma. As wel as managing workloads and deadlines, I also acted as the chief contact between the client and Satel ite. • SAS programming trainer/mentor at Satel ite. • Lead programmer at POL Corp. The main objective was to lead the reporting and programming initiative for a potential blockbuster study in breast cancer. As wel as managing workloads and deadlines, I also acted as the main liaison between Data Management in Italy • Lead programmer at Data Corp. This included managing programming workloads with regard to effectively achieving tight deadlines. The role also incorporated direct contact with the client with the intent of sounding out potential programmatic issues within the early stages • Led an ISM (Integrated Summary of Microbiology) submission. This management included programming al ocation, meeting updates on the progress of the submission and communication with upper management to deal with resource issues and potential submission problems. The drug that was being submitted at the time was Augmentin. • ISE (Integrated Summary of Efficacy) • ISM (Integrated Summary of Microbiology)


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