Training/Internship Brochure Advanced Clinical SAS Programming Full Time 6 months Program

Transcription

1 Training/Internship Brochure Advanced Clinical SAS Programming Full Time 6 months Program Domain Clinical Data Sciences Private Limited /1/2, Road No 11, Banjara Hills, Hyderabad Andhra Pradesh Phone: Trainings@DomainCDS.com Website:

2 Course Modules / Duration Domain Clinical Data Sciences Private Limited is a Clinical Research Organization providing wide range of services to the pharmaceutical and medical devices organizations. We specialize in Data management, Biostatistics and SAS programming, staffing services and both individual and corporate trainings. We bring you this comprehensive full time training program on Advanced Clinical SAS Programming which enables to bridge the gap between being a Beginner and Professional ready for the industry. This training program is first of its kind which bundles both the functional and technical aspects including Advanced SAS programming, CDISC SDTM and ADaM standards, Biostatistics, Statistical analysis and reporting. The curriculum is carefully designed to cover the industry requirement with rigorous internship program with emphasis on hands-on programming and CDISC standards. Upon successful completion of the course, we provide placement services through our staffing division. We also recruit for our internal projects as needed. Courses Modules Module 1: Base SAS Programming Module 2: Advanced SAS Programming Module 3: Clinical Domain Concepts and Regulatory Guidelines Module 4: CDISC SDTM Concepts and Implementation Module 5: Statistical Analysis and Reporting with CDISC ADaM concepts Module 6: SAS Enterprise Guide and SAS on UNIX platform Internship: 2 months of In-house Practical implementation of all the programming and CDISC concepts on Client Projects Prerequisites All life science and statistics graduates/post graduates with basic computer skills All IT Graduates Good communication/presentation skills Good Reasoning and Logical skills Selection Criteria There will be two stages of screening: Stage one: Minimum academic score of 65% and written test on logical, reasoning and communication skills Stage two: Personal interview round Course Duration 16 weeks (4 Months) Training + 8 weeks (2 Months) Internship Week Days: Monday to Friday Timings: 10:00 AM to 5:00 PM Course Group discussions and interactive Sessions Lab Facility with Internet connectivity Assessments on all topics Guidance for SAS certification Training and Internship Certificate Soft Skills Development Resume building Support Placement Support

3 Base SAS Programming Module 1 SAS/BASE Reading data into SAS DATA Step Transforming data using SAS functions SAS Procedures Conditional Statements Do loops Arrays SAS/STAT SAS/BASE Overview of Foundation SAS SAS Window environment Getting Started with SAS Introduction to SAS programs Submitting a SAS program Working with SAS Syntax Fundamental concepts Diagnosing and correcting syntax errors Getting Familiar with SAS Data Sets Examining descriptor and data portions Accessing SAS data libraries Accessing relational databases Reading SAS Data Sets Introduction to reading data Using SAS data as input Subsetting observations and variables Adding permanent attributes Reading External data Using Excel data as input Reading Delimited Raw Data Files Using standard delimited data as input Using nonstandard delimited data as input Validating and Cleaning Data Introduction to validating and cleaning data Examining data errors when reading raw data files Validating data with the PRINT and FREQ procedures Validating data with the MEANS and UNIVARIATE procedures Cleaning invalid data Manipulating Data Creating variables Creating variables conditionally Combining SAS Data Sets Introduction to combining data sets Appending a data set Merging data sets one-toone Merging data sets one-tomany Merging data sets with nonmatches SAS formats DO Loops Conditional Statements SAS Procedures Arrays Producing Summary Reports Using the SAS procedure to create summary reports Enhancing Reports Using global statements Adding labels and formats Creating user-defined formats Subsetting and grouping observations Directing output to external files

4 Advanced SAS Programming Module 2 SAS / Macros Concepts and Features of Macro Programming SAS Macro Facility Advantages, Usage and Examples Mechanics of Macro Processing Macro Variables Concepts Creating macro variables Variables Referencing Macro Variable Resolution Automatic Macro Variables User-Defined Macro Variables Referencing Macro Variables Indirectly Global and Local Symbol table Scope of Macro variables Macro Parameters Concepts Types of Parameters Macro Options Macro Functions Macro Expressions and Statements Constructing Macro Expressions Conditional Processing with the Macro Language Iterative Processing with the Macro Language Masking Special Characters and Mnemonic Operators Storing and Reusing Macro Programs Debugging Macro Programming SAS/GRAPH Creation of Graphics Using SAS/GRAPH Creating bar charts Creating plots Enhancing output SAS/ODS Creation of formatted External outputs using ODS Create RTF, PDF and HTML outputs for statistical summaries and graphics SAS / SQL Introduction to the SQL Procedure What Is SQL? SQL Procedure Terminology PROC SQL Vs. SAS DATA Step Retrieving Data from a Single Table SELECT Statement Creating New Columns Sorting Data Retrieving Rows That Satisfy a Condition Summarizing Data Grouping Data Filtering Grouped Data Validating a Query Creating and Updating Tables Creating Tables Inserting Rows into Tables Updating Data Values in a Table Deleting Rows Altering Columns Deleting a Table SQL joins Using SQL Procedure Tables in SAS Software Using PROC SQL with the SAS Macro Facility Creating and Using Macro Variables in SQL SAS/MACROS SAS/SQL SAS/GRAPH SAS/ODS Statistical Reporting - TFL (Tables, Figures and Listings)

5 Clinical Research and Regulatory Guidelines Module 3 Clinical research is a science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical Research Part 2 Part 1 Drug Development Process Introduction to Clinical Research Clinical Trial Types Different phases Trial Design Different Roles Different Organizations Data Management Data Validation Reconciliation CRF Protocol Statistical Analysis Plan Informed Consent Protocol Case Report Form Database Setup Data Cleaning/Validation Medical Coding SAE Reconciliation Third Part Vendor management External data handling Lab data handling and reconciliation Statistical Analysis Plan Clinical Study Report Part 3 Regulatory Authorities ICH Principles GCP (good Clinical Practices) 21 CFR Part 11 Part 4 Industry Standards SOPs Documentation Approval Process Regulatory Guidlines

6 CDISC SDTM Implementation Module 4 CDISC SDTM Implementation Naming convention Trial Design Mapping CRT-DDS ectd SDTM (Study Data Tabulation Model) Part 1 Introduction to CDISC SDTM Basic Concepts What is CDISC Process Integration? CDISC Scope and Standards Why SDTM? SDTM, the Model Overview of concepts, variables, rules Review of Variables - General Observation Classes Proper Use of the Model Part 2 SDTM Implementation SDTM Standards SDTMIG Standard Domains Controlled Terms, Codelist or Format ISO 8601 Standard vs. Submission Domain models Domains and assumptions Special-Purpose Domains General Observation Classes o Findings o Events o Interventions Representing Non-Standard Variables - SUPPQUAL Relative Times Grouping Variables Intervals and Time Points SDTM Standard Domains Creating Custom Domains SDTM Challenges Relationships CRF versus SDTM Domains Collected versus Domain data Derived Records / Datasets Operational Study Data Part 3 Trial Design Purpose of Trial Design Trial Design Concepts and Datasets ARM and ARMCD Study Cell Inclusion/Exclusion Criteria Elements Epochs Planned Versus Actual Data Part 4 SDTM Mapping Mapping Process Mapping Specifications Annotated CRF creation Conformance Validation Criteria Case Report Tabulation Data Definition Specification (CRT-DDS, also called define.xml)

7 ADaM (Analysis datasets) & Statistical Analysis/ TFL Programming Statistical Analysis and Reporting Module 5 Biostatistics Fundamentals Descriptive Statistics Probability, Confidence Intervals Hypothesis Testing Regression and Correlation Relative risk and Odds ratio Analysis of variance Analysis of Covariance Safety and Efficacy endpoints Safety Analysis Efficacy analysis Listings Generation of listing outputs Summary Tables Demographics Disposition Adverse events Drug Exposure Lab data Vital signs Change from baseline analysis Graphs Bar chart Box plots Scatter plots Risk plots Survival analysis ADaM (Analysis Data model) / Analysis Datasets Analysis Data Model Introduction Definitions Fundamentals of the ADaM Standard Fundamental Principles Traceability The ADaM Data Structures The ADaM Subject-Level Analysis Dataset ADSL The ADaM Basic Data Structure (BDS) Standard ADaM Variables Naming Conventions ADSL Variables ADaM Basic Data Structure (BDS) Variables Implementation Issues and Standard Solutions Fundamental Biostatistics Safety / Efficacy Analysis Listings Summary tables Graphs ADaM (Analysis datasets) ADSL BDS

8 SAS Internship Enterprise Guide and SAS on UNIX Module 6 SAS Enterprise Guide Importing Data Managing Tasks Summary Statistics Graphs Scheduling Processes SAS on UNIX Basic UNIX commands Accessing SAS on UNIX SAS Interface Working with SAS programs SAS Enterprise Guide SAS Enterprise Guide Basics o Starting SAS Enterprise Guide o SAS Enterprise Guide windows o Basic elements of SAS Enterprise Guide o Entering/Importing data o Managing Project and Tasks Creating Reports o Frequency report o Summary statistics tables o Scatter plot o custom styles Working with Data in the Query Builder o Query Builder Basics o Creating a new columns o Ordering and removing columns o Filtering data Joining Data Tables Together Formats Parameters Scheduling Processes Working with code SAS on UNIX platform Basic UNIX commands Accessing SAS on UNIX SAS windowing environment on UNIX Working with SAS programs External program editors Batch submission of the programs

9 Internship Data validation SDTM - acrf - Mapping Specification - Programming - Validation ADaM / ADS - ADS specifications - Datasets Programming and Validation Statistical Reporting - Mocks Shells - Listings - Tables - Graphs - Programming and - Validation SAS programming for Data Management: Creating Data Validation Plan Generation of Data Validation Listings using SAS Reconciliation Listings CDISC SDTM Implementation SDTM Annotated CRF Creation of SDTM Mapping Specifications Creation of Metadata Programming of SDTM Domains - DM, AE, DS, LB, VS, EX - TA, TE, TV, TS, TI Validation of Datasets Creation of Define.xml Derived dataset creation - ADaM Create ADaM specifications ADaM datasets Programming - ADSL, ADAE, ADEX, ADLB, ADVS Dataset Validation Statistical Reporting Creation of Mock Shells Generation of Listings, Summary tables, Graphs using SAP and Mock Shells - Demographic Tables - Adverse Event tables - Disposition tables - Exposure tables - Lab Tables and Graphs Patient Profiles Creation of RTF/PDF report outputs Validation programming Patient profile PDF creation Upon successful completion of the Internship: Placement services through our staffing division We also recruit for our internal projects as needed