SUMMARY

• Skilled SAS Programmer with pre - clinical, pharmacology and oncology research background with total experience of 8+ years, have 4.5 years of SAS programming experience in pharmaceutical, clinical and biotech industrial settings.
• Expertize in using SAS versions 9.1, 9.2: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/ACCESS and SAS/SQL in MS-Windows environment, for clinical trial analysis and reporting.
• Experience in importing data files from external data sources like Oracle database, Access database, SQL, Excel, delimited and Flat files, using SAS procedures such as PROC IMPORT, Import Wizard, and SAS statements.
• Hands on experience in developing SAS procedures, Formats, Informats, Functions, Macros, storing and managing data in SAS files, generating datasets, data analysis, merging SAS datasets, data validation, data cleansing, and report writing.
• Proficient in generating reports using SAS procedures such as PROC SQL, PROC REPORT, PROC TABULATE, PROC MEANS, PROC SUMMARY, PROC FREQ, PROC CONTENTS, PROC TRANSPOSE, PROC GPLOT, PROC GCHART, PROC PRINT, and PROC UNIVARIATE.
• Experience in debugging and testing SAS programs using DATA NULL and PUT statement.
• Excellent knowledge of SAS/ODS to export SAS results into different formats such as RTF, Excel, PDF, HTML, and XML and to produce ad-hoc reports for presentation and further analysis.
• Experience in grouping information using BY-group processing in the DATA and PROC steps when creating reports and summaries.
• Experience in Data manipulation on SAS datasets using techniques such as merging, appending, concatenating and sorting.
• Thorough knowledge of various clinical documents such as Protocol, CRF, aCRF, SAP and SOP.
• Good understanding of FDA regulations, International Conference of Harmonization (ICH), Good Clinical Practice (GCP) guidelines.
• Familiarity with CDISC standards, MedDRA, 21 CFR Part 11, and other regulatory submissions (IND and NDA, including ISE and ISS).
• Good understanding of different phases of clinical trials, study protocols and analysis plans, drug development and approval processes with experience in selection of appropriate statistical methodology, creating SAS datasets, analyze clinical data from CRF, generating efficacy and safety reports, summarization, and reporting for phases I, II and III clinical trials.
• Hands-on experience in working with Clinical Trials data like Demographic data (DM), Adverse Events (AE), Serious Adverse Events (SAE), laboratory data (LAB DATA), Concomitant Medications (CM), Subject Visits (SV), Medical History (MH), Disposition (DS), Clinical Events (CE), Protocol Deviation (DV), Physical Examination (PE), and vital signs (VS).
• Strong understanding of various clinical and therapeutic areas like oncology, virology, epidemiology, cardiovascular and GI systems, allergy, and other diseases.
• Excellent familiarity with terminologies in clinical medicine, oncology, immunology, pharmacology, biology, cell and molecular biology, biotechnology, microbiology, chemistry and biochemistry.
• Experience in handling / working on multiple projects and ability to quickly adapt to new applications and platforms.
• Very good team player with excellent communication skills and ability to work independently under minimum supervision in a fast paced environment and under deadlines.
• Underwent advanced postdoctoral research training in pre-clinical animal models, cancer biology, molecular and cell biology, and biotechnology.
• Worked as a part of interdisciplinary research teams involved in translational medical research and drug development pipeline, with applications to human health.
• Performed preclinical evaluation of a small molecule inhibitor based chemotherapeutic drug for efficacy and safety in mouse xenograft models and cell culture models.
• Performed drug toxicity tests to evaluate the LD50 and safety dose for the small molecule inhibitor drug.
• Successfully developed a combination drug treatment targeting STAT3 and HIF 1-alpha to treat prostate cancer, and proved the in vivo efficacy of the drug in a pre-clinical mouse model and cell culture models.
• Created a rat model to study the efficacy of interleukin-6 (IL-6) in resuscitating rats from trauma and hemorrhagic shock.
• Investigated the role of epigenetic regulators (NSD1) as novel drug targets in prostate cancer.
• Successfully developed a stable knock-out cancer cell line for evaluating NSD1 as cancer drug target in in vivo models.
• Hands-on experience with handling and maintenance of cancer cell lines and mesenchymal stem cells.
• Published peer-reviewed first authorship papers in internationally recognized medical journals.

TECHNICAL SKILLS

Sas tools: SAS v9.1, v9.2, SAS/BASE, SAS/ACCESS, SAS/SQL, SAS/MACROS, SAS/REPORT, SAS/GRAPH, SAS/STAT, SAS/ODS.

SAS procedures: Proc Print, Means, Univariate, Report, Summary, Tabulate, Freq, Sort, Format, Copy, Compare, Gplot, Transpose, SQL, Import, Export, Append.

Databases: Oracle, MS Access

Operating Systems: Windows 98/2000/XP/Windows 7/Vista/Windows 8

Office tools: MS Office 2000/2007/2010/2013 (Word, Excel, Power point, Access, Outlook, Publisher)

Therapeutic areas: Oncology, Pathology, Virology, Bacteriology, Immunology, Neuroscience, Infectious Diseases.

PROFESSIONAL EXPERIENCE

Confidential, Madison, WI

Sr. SAS Clinical Programmer

Responsibilities:

• Involved in SAS programming for analyzing and coordinating clinical trial data, generating data tables and listings for reporting on safety and efficacy.
• Provide statistical programming support, validation and set up specifications for analysis datasets, pooled datasets for ISS and ISE integration studies, statistical summary tables, figures and listing for phase I -III clinical trials.
• Created programs for validation and verification of quality/integrity of datasets, listings, analysis files and tables.
• Developed standard report for safety data including laboratory and adverse event summaries for NDA (New Drug Application) updates using PROC REPORT and DATA NULL
• Utilized Data Null and SAS procedures such as REPORT, TABULATE, FORMAT, APPEND, FREQ, MEANS, SUMMARY and TRANSPOSE for producing ad-hoc and customized reports and external files.
• Involved in sorting, printing and summarizing the SAS Data, modifying and combing SAS datasets (SORT, SET, MERGE)
• Used SAS/ACCESS, SAS/MACRO to access and modify data according to the client requirements.
• Developed utility Macros for standard reports and validations.
• Involved in creating various SAS Reports in compliance with 21 CFR Part 11, and FDA regulations for electronic data submission.
• Working with the leads and statisticians on dealing with efficacy analysis data of multiple clinical projects.
• Functioning with Data Management Group to create data clean and data validation listings. Using Edit checks regularly for the detection of new errors.
• Attending project team meetings, worked with bio-statisticians, data management team, and clinical research managers as appropriate.

Confidential, Gaithersburg, MD

SAS Clinical Programmer

Responsibilities:

• Provide broad expertise in all aspects of the SAS Programming field. This will be in accordance to company policies, Standard Operating Procedures (SOPs) and applicable regulatory guidelines.
• Developed routine SAS Macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• Accessed and modified data using SAS procedures like PROC IMPORT and PROC EXPORT, PROC FORMAT and PROC SORT, merging the sorted datasets and generating reports as PDF, RTF or HTML files using SAS ODS.
• Generated adhoc-reports and key analytical reports on daily, weekly, monthly basis for presentation and further analysis.
• Reviewed statistical programming plans (SPPs) and statistical analysis plan (SAPs) and provided feedback to biostatistician.
• Generated safety and efficacy tables and listings for different studies from ISS and ISE.
• Performed study of Safety and Efficacy (sensitivity). Performed all the statistical aspects of the clinical trials including experimental design, selection of appropriate statistical methodology, interim statistical analysis, and reporting in multiple oncology projects.
• Reviewed CRFs, database annotations, Protocol and annotated CRFs while writing the specifications.
• Generated necessary outputs required for CSRs (clinical study reports), integrated summaries and electronic submissions.
• Ensured accuracy of all results and provide appropriate documentation.
• Developed SOPs and documentation support in accordance with 21 CFR Part 11.
• Performed data editing, cleansing, manipulation and analysis for various SAS programs.
• Identify opportunities to improve the methodology and provide practical solutions for problems.
• Contributed to the development of best practice to improve quality, efficiency and effectiveness.

Confidential, Madison, NJ

SAS Clinical Programmer

Responsibilities:

• Provided SAS clinical programming support for clinical trials in multiple therapeutic areas - Cardio-Vascular, and Oncology, across phases I to III.
• Provided programming support and validation of analysis datasets, pooled datasets, statistical summary tables, figures and patient data listings for phase I to III clinical trials.
• Developed and reviewed SAS programs and output for the management and reporting of clinical trial data.
• Worked on different domains of clinical trials data like Demographic data, adverse event, serious adverse events, laboratory data, physical and vital signs.
• Contributed to writing SAP and protocol reviews. Reviewed study Protocol, Case Report Forms (CRF) and performed validation of clinical trial data to identify illogical data entries.
• Generated reports/listings/analysis datasets/graphs based on Statistical Analysis Plan (SAP) and ad hoc reports/graphs for FDA queries using PROC MEANS, PROC FREQ, PROC TRANSPOSE, PROC TABULATE, PROC UNIVARIATE, Data null, PROC REPORT, PROC GCHART and PROC GPLOT Procedures.
• Used options like noduprec, nodupkey to delete duplicate records within the datasets.
• Developed Data step programming using SAS functions namely INPUT, PUT, SUBSTR, INDEX, SCAN, COMPRESS, CATX
• Performed routine quality check on datasets, aCRF to ensure their accuracy according to the client specifications. Provided appropriate feedbacks wherever necessary.
• Involved in writing, editing, validating, debugging code and developed new SAS programs and modified existing datasets using Set, Merge, Sort and Proc SQL with various SAS functions.
• Used SAS/ODS to generate reports in Excel, PDF, RTF, HTML and format the data using PROC FORMAT, PROC APPEND and MERGE statement.
• Worked closely with medical writers, data-managers, clinical monitors, statisticians and fellow programmers.