Software Training

Clinical Programming Using SAS® 9.4 Training Syllabus

• Basic SAS^®
• SAS^® Macros
• SAS^® SQL
• SAS^® Graphs
• Introduction to clinical research and terminologies in clinical research
• Phases of clinical trials & drug development process
• Principles of GCP and Schedule Y
• Regulatory and ethical guidelines in clinical research
• Informed consent- Elements and documentation
• Clinical Trial – Key Documents
• Introduction to CDISC, SDTM & ADaM
• 10 Clinical Case Studies

Clinical Trials Process

• Describe the clinical research process (phases, key roles, key organizations).
• Interpret a Statistical Analysis Plan.
• Derive programming requirements from an SAP and an annotated Case Report Form.
• Describe regulatory requirements (principles of 21 CFR Part 11, International Conference on Harmonization, Good Clinical Practices).

Clinical Trials Data Structures

• Identify the classes of clinical trials data (demographic, lab, baseline, concomitant medication, etc.).
• Identify key CDISC principals and terms.
• Describe the structure and purpose of the CDISC SDTM data model.
• Describe the structure and purpose of the CDISC ADaM data model.
• Describe the contents and purpose of define.xml.

Import and Export Clinical Trials Data

• Combine SAS data sets.
• Efficiently import and subset SAS data sets.
• Access data in an Excel workbook (LIBNAME and PROC IMPORT/EXPORT).
• Create temporary and permanent SAS data sets.
• Apply regulatory requirements to exported SAS data sets (SAS V5 requirements).

Manage Clinical Trials Data

• Investigate SAS data libraries using base SAS utility procedures (PRINT, CONTENTS, FREQ).
• Access DICTIONARY Tables using the SQL procedure.
• Sort observations in a SAS data set.
• Create and modify variable attributes using options and statements in the DATA step.
• Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc).

Transform Clinical Trials Data

• Process data using DO LOOPS.
• Process data using SAS arrays.
• Retain variables across observations.
• Use assignment statements in the DATA step.
• Apply categorization and windowing techniques to clinical trials data.
• Use SAS functions to convert character data to numeric and vice versa.
• Use SAS functions to manipulate character data, numeric data, and SAS date values.
• Transpose SAS data sets.
• Apply ‘observation carry forward’ techniques to clinical trials data (LOCF, BOCF, WOCF).
• Calculate ‘change from baseline’ results.
• Obtain counts of events in clinical trials.

Apply Statistical Procedures for Clinical Trials

• Use SAS procedures to obtain descriptive statistics for clinical trials data (FREQ, UNIVARIATE, MEANS, SUMMARY).
• Use PROC FREQ to obtain p-values for categorical data (2×2 and NxP test for association).
• Use PROC TTEST to obtain p-values for continuous data (one-sample, paired and two-sample t-tests).
• Create output data sets from statistical procedures.

Macro Programming for Clinical Trials

• Create and use user-defined and automatic macro variables.
• Automate programs by defining and calling macros.
• Use system options to debug macros and display values of macro variables in the SAS log (MPRINT, SYMBOLGEN, MLOGIC, MACROGEN).

Report Clinical Trials Results

• Use PROC REPORT to produce tables and listings for clinical trials reports.
• Use ODS and global statements to produce and augment clinical trials reports.

Validate Clinical Trial Data Reporting

• Explain the principles of programming validation in the clinical trial industry.
• Utilize the log file to validate clinical trial data reporting.
• Use programming techniques to validate clinical trial data reporting (PROC COMPARE, MSGLEVEL).
• Identify and Resolve data, syntax and logic errors.

Practical Training

Class room practical training to demonstrate SAS programming procedures, reporting, coding etc…

Tools Used

SAS^® 9.4 License version software.

Eligibility

Candidates are preferred from

• Life sciences (M.Pharm., B.Pharm., M.Sc.)
• Statistics (B.Sc., M.Sc.)
• BE /BTech (Biotechnology,Bioinformatics,Computer Science)
• MBBS, BDS, BHMS and BAMS

Features of this course

• Training curriculum is specially designed by SAS institute with its deep global expertise in biostatistics and clinical programming
• We are offering substantial and quality Clinical SAS^® Training
• Trainers are experienced clinical SAS^® programmers with exposure to global clients including large Pharma and Biotech companies
• Course covers fundamentals of clinical operations
• Practical exposure to SAS^® Programming with case studies
• Datasets and examples related to clinical trials domain
• Regular assessments to improve and rank the performance
• Soft skills training to facilitate placements
• In-house recruitment and placement assistance

Clinical SAS Training & Placement

Since 2011 over 1500 students have been placed in various analytics companies from niche start ups to large multinationals.
Greens Technology help companies to hire certified and trained candidates on SAS. GT now serve companies on Clinical & Life Sciences, Consulting, Market Analyst, Business Analyst and other background to find rightful talent who successfully fill up the gap for required set of skilled professionals.

Clinical SAS Training Course Highlights:

• 1) Two days free trial – If candidate likes this course, these days are adjusted in his actual schedule.
• 2) Live Project Exposure of Fortune companies.
• 3) Training by Subject Matter experts from CMM Level 5 companies
• 4) Running in two major financial cities of India – Chennai and Bangalore
• 5) Worldwide Classroom training of Clinical SAS and corporate classes at affordable fees.
• 6) Our basic course worth more than the advanced course of other institutes/freelancers.
• 7) Free Interview preparations.
• 8) 100% free assistance for Clinical SAS certifications.
• 9) 100 % guarantee in succeeding the certification at affordable fees.
• 10) Also provide Classroom training to students of foreign countries.
• Learn Clinical SAS Training from the Best Clinical SAS training Institute in Chennai

Key Differentiators Clinical SAS Training at Greens Technologys

• Courses are designed by Experts with over 25 years of rich and variegated experience in Clinical Trial Analytics.
• Faculty members are not trainers; they are real world experienced statistical programmers.
• Students learn to tackle real life situations such as imperfections in data and programming specifications.
• We cover all aspects of projects, such as meetings, discussions, specifications, clarifications and Quality Control; going much beyond the programming part.
• You are better equipped to face job interviews, with Industry-recognized Internship Certificate and Experience letter to establish your credentials. We also groom you for interviews.
• We use authorized and licensed software.

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Clinical SAS Training Duration

• Regular classroom based Clinical SAS training available for this course on both Weekdays / Weekends
• Fast Track (1-1): No of hours per day can be as per convenience of participant.
• Weekend classroom classes are available for this course.

Clinical SAS – Prepare for Certification

Get Certified With SAS Certified Clinical Trials Programmer Using SAS 9