Statistical Programmer Resume

OBJECTIVE:

Clinical SAS Programmer seeking to obtain a position in a reputed organization in the field of clinical research, where I can ameliorate my knowledge, utilize technical & analytical skills to the best of my ability and contribute towards the growth and progress of the organization.

SUMMARY

Certified clinical SAS programmer with 5 years of programming experience within the pharmaceutical and CRO field.
Well acquainted with the Clinical terminology, Regulatory Guidelines & practical experience of analyzing and reporting in phase I, II, III and IV of clinical trials.
Good knowledge of CDISC SDTMIG (3.1.2) and ADaM (1.0).
Experience in generating and validating SDTM/ADaM Datasets, Tables, Listings and Graphs (TLG’s) using SAS.
Coordinated the integration of clinical trial databases to support creation of integrated summaries of safety and efficiency (ISS and ISE).
Extensively worked on various therapeutic areas like, Metabolic disorders (Anti - diabetic & Obesity), Oncology, Dermatology.
Experience in SAS/BASE, SAS/SQL, SAS/ACCESS, SAS/MACROS, SAS/GRAPH, and SAS/ODS.
Good knowledge of Define.XML and also worked on eCRT submissions for FDA.
Experience in Producing RTF, HTML and PDF formatted files using SAS/ODS.
Possess good analytical and problem-solving skills.
Excellent team player with high level of personal initiatives.

TECHNICAL SKILLS

SAS Tools: SAS 9.4, SAS Enterprise Guide 7.1

SAS Skills: SAS/Base, SAS/MACROS, SAS/ODS, SAS/ACCESS, SAS/SQL, SAS/GRAPH, and SAS/STAT

Operating Systems: Windows, Unix

PROFESSIONAL EXPERIENCE

Confidential

Statistical Programmer

Responsibilities:

Identified opportunities for increased efficiency and consistency and contributed to the improvement and standardization of processes.
Communicated effectively within a multi-disciplinary project team to prioritize and complete assigned tasks on time.
Documented, tracked and resolved the issues in the Programming Plan.
Involved in the development and validation of ADaM datasets like ADSL, ADAE, ADCM, ADVS, ADLB etc.
Strong experience using SAS/GRAPH to produce Graphs by employing SAS procedures such as PROC GPLOT and PROC GCHART.
Used procedures like PROC FREQ, PROC MEANS, PROC TABULATE, PROC SUMMARY and PROC REPORT to generate data tables, listings and reports according to Statistical Analysis Plan.
Creating Safety tables like - Demographics, Subject Disposition, Adverse Events, ECG and Lab Shift tables etc.
Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/BASE and SAS/MACRO facility.
Maintained and wrote reusable SAS MACROS.
Testing and debugging the existing Macros.
Provided support for submission team by converting various SAS data files into transport files (.xpt) using PROC COPY and generated other metadata to be used in the creation of define.xml
Involved in the Quality Control for derived datasets and outputs to ensure the output is complete match after independent programming, using PROC COMPARE etc.
Actively involved in various knowledge sharing sessions to acquire new skills like GTL (Graphic template language), SAS Hash Objects, PERL functions etc.

Confidential

Clinical SAS Programmer

Responsibilities:

Involved in writing and updating the specifications for CDISC ADaM datasets following ADaM IG guidelines, SDTM datasets, annotated mockup shells.
Produced and Validated Oncology related SDTM domains like Tumor Identification (TU), Tumor Respose (TR), and Findings About (FA)
Worked on Oncology listings, Summary tables and Oncology endpoints like Disease free survival, Overall survival, Progression-free survival methods.
Helped data management on SAS edit check programs to maintain data consistency.
Worked with cross-disciplinary teams, Senior Statisticians, Medical Writers, and Project Managers to assure programming needs are met, effectively organized and managed multiple assignments with challenging timelines
Developed Ad Hoc reports as required by medical writers and FDA.
Performed quality review and validation of SAS programs generated by other SAS programmers. Followed good programming practices and adequately documented programs.
Conducting training sessions for Interns.

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