MP SHALINI

Internee SAS Programmer

Mobile: +91 7893269696
Email – ID: shalinimenon.sm@gmail.com

SUMMARY:

 Flexibility and ability to work in a team, comfortable with multitasking.

 Good Knowledge in Clinical SAS Programming and various processes in Clinical Development.
 Well- versed with ICH GCP, CDISC, 21CFR Part 11 and GCDMP guidelines and regulations.
 Good knowledge of processes for planning, conducting, and data processing of clinical trials data.
 Good knowledge of FDA and ICH regulations applicable to the design, analysis and reporting of clinical
trials.
 Good understanding of drug development processes, Clinical Trail Management Process Flow, Clinical Data
Management Process flow.
 Good Knowledge in CDISC SDTM Implementation and Mapping.
 Good programming experience with Base SAS, SAS Macro Language and SQL Procedures.
 Expertise in Data Processing using SAS Data step and Base Procedures like FORMAT, SORT, TRANSPOSE,
SQL.
 Extensive knowledge in Data Validation of Prior and After Analysis Datasets using SAS Base Procedures like
COMPARE, FREQ, MEANS, SQL , PRINT and using Data step.
 Good comprehension of FDA guidelines, ICH-GCP Guideline esp. E3, E6, E9 guidelines
 Good conceptual and applied knowledge CDISC standards especially SDTM IG v3.1.2
 Thorough understanding of Clinical Trial Management System (CTMS) & all phases (Phase I - IV) of clinical
trial.
 Good working knowledge of major Clinical data management package like Oracle Clinical 4.6
 Ability to understand and work according to Protocol.
 Dedicated and trustworthy team worker with excellent communication and analytical skills.
 Highly energetic person committed to achieve goals set forth.
 Great oral and written communication skills.

EDUCATION:

 Diploma in Clinical Data Management and Biostatistics Aug’11 – Dec’11.

International Drug Discovery and Clinical Research (IDDCR Pvt. Ltd), Hyderabad.

 Master of Science in Biochemistry May’11

Aurora’s Degree & P.G College (Osmania University), Hyderabad, Andhra Pradesh

 Bachelor of Science May’08

Aurora’s Degree & P.G College (Osmania University), Hyderabad, Andhra Pradesh

WORK EXPERIENCE:

IDDCR Pvt. Ltd – Hyderabad (India) Internee – Clinical SAS Programmer Jan, 2012 – till date
OTHER WORK EXPERIENCE:

 Senior Executive, Apollo Health Street, Hyderabad. May’2008- Sep’2009

Revenue Cycle Management- Medical billing, A/R Denial Management.

 Achievements
Consistently met and exceeded KRA (Key Responsibility Areas) Targets.

Received several rewards and recognition for performance on Quality.

- Received the Best performer for January and February-2009

- Received the star of the month for Jan-2009.

 Freelance Subject Matter Expert and QA- Editing (Chemistry) for an

Independent e-learning Organization. Sep’2010- Till Date

TECHNICAL SKILLS:

SAS System 9.2 SAS/BASE, SAS Macro Language, SAS SQL Procedure and SAS/Graph

Databases Oracle 9

Operating System Windows XP and Seven

Languages SQL

Office Packages MS Office 2003 and 2007 (Word, Excel, PowerPoint)

INTERNATIONAL TRAINING CERTIFICATES:

 The SAS training certificate—SAS programming I: Essentials

The SAS training certificate—SAS programming II: Manipulating Data with the DATA Step
 The SAS training certificate—SQL Processing with SAS
 The SAS training certificate—SAS Macro Language

INTERNATIONAL CERTIFICATIONS / ASSOCIATIONS:

Base SAS Certification SAS®9 – Planning for next month