Biostatistics

Statistics provides the basic framework for thinking about data in a rigorous
fashion. Biostatistics applies this rigorous examination of data to information
gathered in the biological sciences, including clinical trials, public health, genetics,
and genomics. It seeks to differentiate between correlation and causation to
uncover the proper interpretation of data.

This course is intended as both a refresher course and as a first course in the
applications of statistical thinking and methods. Both descriptive and inferential
statistics will be covered, and students will complete a collaborative, real-life
project demonstrating their understanding of the methods and applications covered
in the course.

Topics include:

 Basic probability
 Discrete and continuous distributions
 Descriptive statistics
 Confidence intervals
 Hypothesis testing
 Correlation
 Simple regression
 Chi-square tests
 Analysis of variance (ANOVA)

Practical experience:

 Organize, summarize and present data

 Describe the relation between two variables
 Understand basic probability and probability distributions
 Work with sample data to make inferences about a population

Software: Students will need access to Excel or a similar spreadsheet software to

complete course assignments.

Prerequisites: None.
SAS Programming I: DATA Step and PROC Fundamentals
The SAS system is a software suite for data analysis and management, widely
used in business, government, and academia. Because the pharmaceutical,
biotech, and clinical research industries use SAS to analyze clinical trial data, SAS
programmers are in especially high demand in these industries.

In this course, students will learn the tools necessary to write SAS programs to
perform elementary data management, analysis, and reporting. Students will also
gain the skills necessary to create and document data sets, manage and reshape
data, write simple reports, and compute basic statistics on dataset variables.

Topics include:

 Creating, viewing, and inspecting SAS data sets

 Formats and labels
 Conditional processing
 Iterative processing
 Numeric functions and missing values
 Subsetting, interleaving, and merging data sets

Practical experience:

 Writing SAS programs to read in data, manipulate the data, and generate
reports

Software: Students must download and install SAS OnDemand for Academics:
Enterprise Guide. There is no additional cost for this product. Registration and
download information will be provided by the instructor on the start date.

Prerequisites: Completion of Introduction to Programming or basic programming

skills required.
Biostatistical Methods I: Linear Regression and ANOVA
Regression analysis is used to estimate the relationships between variables, and
includes many different techniques. Linear regression serves as the basis for other
types of regression. It is used extensively in many fields, but especially in the
biomedical field.

This course covers simple and multiple linear regression, analysis of variance and
covariance, and nonparametric analysis. Model building techniques, evaluating
model fit, and dealing with violations of model assumptions are also introduced in
this course. Through the completion of real-world problems, students will learn to
analyze continuous response data and to write the method and result sections for a
scientific paper.

Topics include:

 Simple linear regression

 Multiple linear regression
 Analysis of variance and covariance (ANOVA and ANCOVA)
 Model diagnostics
 Nonparametric analysis

Practical experience:

 Use SAS to analyze continuous response data

 Write method and result sections for a scientific paper

Software: Students will use SAS OnDemand for Academics: Enterprise Guide.
There is no additional cost for this software. Registration information will be
provided by the instructor on the course start date.

Prerequisites: Biostatistics and SAS Programming I or equivalent experience

required.
Biostatistical Methods II: Logistic Regression and Survival Analysis
The most common types of analysis in the healthcare or pharmaceutical industries
are logistic regression models and survival analysis. To analyze data with
dichotomous outcomes, such as having (or not having) a certain disease, one often
needs to use a logistic regression model. Survival analysis focuses on time to
event data. The event of interest can be death (most commonly encountered) or
occurrence of a disease.

In this course, students learn to identify situations when it is best to utilize logistic
regression and survival analysis and how to run these types of analysis by using
SAS software. Sample size calculation and power analysis are also introduced.

Topics include:

 Simple logistic regression

 Multiple logistic regression
 Goodness of fit and model diagnostics for logistic regression
 Introduction to survival analysis
 Cox Proportional Hazards Model
 Model diagnostics for Cox Proportional Hazards Model
 Nonproportional Hazards Model
 Power and sample size analyses

Practical experience:

 Use SAS to run logistic regression and survival analysis

 Write method and result sections for a scientific paper

Software: Students must download and install SAS OnDemand for Academics:
Enterprise Guide. There is no additional cost for this product. Registration and
download information will be provided by the instructor on the start date.

Prerequisites: Completion of Biostatistical Methods I: Linear Regression and

ANOVA required.

Note: Instructions for ordering the course reader (e-textbook) will be provided on
the first day of class.
Introduction to Programming
Python is a relatively easy programming language to learn. Python statements can
be interpreted using various operating systems. This course was developed with
the first time programmer in-mind. Students will learn rules and syntax applicable
to a modern programming language, learn how to understand and develop
algorithms, gain an understanding of general programming constructs including
variables, expressions, functions, branching, looping statements and data storage.
Students will also design, write and debug simple computer programs using
Python. This course serves as a good foundation for students looking to further
their training in C, C/C++ and C# programming languages.

Course Highlights

 Computers and programming

 Storing and processing information
 Variables and expressions
 Branching statements
 Basic logic
 Looping and repetion statements
 Basic data structures
 Programming styles
 The languages Application Program Interface (API)
 Reading and writing to files
 Object oriented programming
 Frameworks and tools available to programmers

Course Benefits

 Attain the ability to participate in technical conversations

 Understand the rules and syntax of a programming language
 Walkthrough programming constructs
 Ask the right questions
 Write functional code in Python
 Be prepared for more in-depth programming courses

Note: Prerequisites: Students must have access to a web-enabled computer.

Strong problem-solving skills and computer familiarity is highly recommended.
CDISC Standards for Clinical Data
The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit
organization that develops and supports data standards to improve medical
research and ensure research data is easily interpreted and understood by
regulators. The CDSIC established standards support the acquisition, exchange,
submission and archive of clinical research data.

In this course, students will learn the skills and tools necessary to apply the CDISC
standards when processing clinical data used for FDA submissions. Specifically,
this course will focus mapping raw datasets to CDISC’s Study Data Tabulation
Models (SDTM) and Analysis Dataset Models (ADaM).

Topics include:

 CDISC terminology and standards

 ISO 8601 dates and durations and creating DM and ADSL demog datasets
 Processing AE, SUPPAE and ADAE adverse datasets
 Converting LB and ADLB Lab datasets
 Understanding QS, RELREC, EX and TE/TA/TV datasets
 Validation of SDTMs and ADaMs
 ODM-XML files structure and content
 Creating and QCing DEFINE.XML
 Understanding oncology domains

Practical experience:

 Create DM/SUPPDM and ADSL datasets

 Create AE and ADAE datasets
 Create LB dataset

Software: Students must download and install SAS OnDemand for Academics:
Enterprise Guide. There is no additional cost for this product. Registration and
download information will be provided by the instructor on the start date.

Prerequisites: Prior knowledge of clinical trials and familiarity with SAS

programming (such as SAS Programming I) suggested.