Biostatistics & Clinical Statistical Programming
Download the Syllabus to view sample certificates and course details for your professional growth.
CLINICAL DATA MANAGEMENT & SAS
Global Institute of Health Science is a pioneer in health science education, especially in distance and online learning. The institute is ISO 21001:2018 certified and globally acclaimed, with copyright approval from IPR Government of India and international certification from UASL UK for Quality Control Management Systems.
The GIHS Advantage
- Bringing Excellence to Health Professionals
- 15+ Years of Experience with International Exposure
- Internationally Acclaimed with ISO & Government Approval
- Lifetime Free Personalized Tutoring for Student Success
This GIHS Clinical Data Management and SAS Program is developed to provide candidates with a skillful knowledge of the management of clinical data used in clinical trials and other projects, leading to an academic and professional qualification for Clinical Data Management. The program is meant for health information managers, data managers and other healthcare professionals working with, or planning to work with, clinical data and other health databases. SAS Clinical Data Integration organizes, standardizes and manages clinical research data and metadata. It provides the foundation you need to define analysis data sets and support strategic analyses such as cross-study and advanced safety analysis. With SAS, you can gain both speed and efficiency by automating repeatable clinical trial data integration tasks. For beginners Clinical Data management and SAS data management training course programs aid a great start up.
Syllabus
Clinical Data Management
- Introduction of Clinical Data Management
- Data and Databases
- Data Entry
- Transcribing Data
- CRF Data Tracking
- Cleaning Data
- Discrepancies Managements
- Data Management Plan
- CRF Review and source Documents
- Electronic Data Capture
- Design Consideration
- Study Setup
- Managing Laboratory Data
- Collection of Adverse Events Data
- Medical Coding
- Creating Reports
- Data Acquisition and Database Closure
- Data Transfers / Audit trial
- QA in CDM
SAS – STATISTICAL ANALYTICAL SYSTEM
- SAS Introduction
- SAS syntax / SAS Dataset
- Reading SAS Dataset
- Reading Excel Worksheet
- Reading delimited Raw Data File
- Manipulating Data / Combining SAS Data Set
- Do Loop & Array Processing / SAS Function
Biostatistics & Clinical Statistical Programming
The GIHS Biostatistics & Clinical Statistical Programming course aims to develop essential statistical knowledge and practical programming skills required for clinical research and pharmaceutical data analysis. The program focuses on statistical concepts, clinical trial methodology, data management, statistical programming using SAS and R, and interpretation of clinical study results. Students gain an understanding of hypothesis testing, regression analysis, survival analysis, sample size calculation, statistical analysis plans (SAP), CDISC standards, SDTM and ADaM datasets. The course enables professionals to analyze clinical trial data, evaluate treatment outcomes, ensure data accuracy and support evidence-based medical research in compliance with global regulatory guidelines. It also develops competencies in clinical statistical reporting, tables, listings and figures (TLFs), data validation and regulatory submission requirements. The GIHS online training program supports professional career advancement in biostatistics, clinical statistical programming and pharmaceutical research through flexible learning, professional certification and placement assistance.
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Biostatistics & Clinical Statistical Programming
Biostatistics & Clinical Statistical Programming is a specialized field of clinical research that focuses on the application of statistical methods, data analysis and programming techniques to evaluate the safety and effectiveness of pharmaceutical products, medical devices and healthcare interventions. The GIHS Biostatistics & Clinical Statistical Programming Program is designed to provide comprehensive industry-level knowledge in clinical trial data analysis, statistical methodologies, SAS programming, R programming and clinical research data interpretation. The program covers descriptive and inferential statistics, hypothesis testing, clinical trial design, statistical analysis plans (SAP), CDISC standards, SDTM, ADaM and clinical study reporting. It helps healthcare, pharmaceutical, biotechnology and clinical research professionals develop essential analytical skills while understanding ICH-GCP, USFDA and EMA regulatory requirements. This online certification program prepares professionals for career opportunities in biostatistics, clinical statistical programming, clinical data analysis and pharmaceutical research across global healthcare and clinical research organizations.
Career-Relevant Skills You Will Develop
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Biostatistics for clinical trials
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Trial design, randomisation and sample size
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Endpoints, estimands and analysis populations
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Statistical analysis plan development
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CDISC SDTM and ADaM concepts
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SAS programming for clinical data
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R programming awareness for clinical analysis
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Tables, listings and figures production
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Validation, double programming and QC
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AI-enabled statistical programming literacy
Career Options
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Clinical SAS Programmer
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Statistical Programmer / Analyst
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Biostatistics Associate
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Clinical data science and analytics support
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CDISC / standards support roles
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Clinical data management interface roles
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Statistical QC and validation support
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Real-world evidence and observational analysis support
Eligibility
- All Science Graduates, MBBS, BDS, BHMS, BAMS, BPT, BUMS, B.Sc., M.Sc., Life Science, IT Professionals, Medical Laboratory, Nursing, Microbiology, Biomedical, Biotech and all professionals working with Hospitals & Healthcare Organizations. Also open to: any graduate and working professionals.
Mode or Methodology
- Online & Distance Learning, self-paced
- Lifetime personal expert support
Certification
- GIHS Certificate for successful candidates, verifiable online
Eligibility
- Online & Distance Exams (MCQ / Theoretical) / Projects
Placement Assurance
- Placement support for successful candidates
- CVs forwarded to organizations, 2,000+ placed
Fees, Payment & Program Duration
Certificate Program
- Duration : 3 Months
- Foundation-level program
- Industry awareness focus
- Expert-designed syllabus
- Research-based curriculum
- Academic & tech support
- Skill development course
- Global accreditation & Govt-recognized
₹22,999
- Indian candidates
- $450* USD For International Candidates
Post Graduate Diploma Program
- Duration : 1 Year
- Advanced-level professional course
- Research-based modules
- Lifetime expert support
- Job & career assistance
- Free Career Boost (www.TopCVCoach.com)
- High employment potential
- Global accreditation & Govt-recognized
₹32,999
- Indian candidates
- $699* USD For International Candidates
*Fees subject to taxes & exchange rates.
Fast Track PG Diploma Program
- Duration : 4 Months
- Accelerated PG-level program
- Flexible learning format
- Lifetime expert support
- Research-driven curriculum
- Free Career Boost (www.TopCVCoach.com)
- Job-oriented training
- Global accreditation & Govt-recognized
₹36,999
- Indian candidates
- $750* USD For International Candidates
*Fees subject to taxes & exchange rates.
- Disclaimer: This course details are for the purpose of awareness about the program and career opportunities. The exact information on course structure may vary from this information.
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Frequently Asked Questions
It is the structured process of collecting, reviewing, cleaning, coding, reconciling and preparing clinical-research data so
that it is accurate, consistent, traceable and suitable for analysis and reporting.
CDM gives you the workflow and quality thinking; SAS gives you the tool for working with structured datasets. Together
they cover both the operations and the analytical side of clinical-research data.
The syllabus covers SAS introduction, syntax, datasets, reading Excel and delimited files, data manipulation, combining
datasets, DO loops, arrays and functions. It builds the foundation; proficiency comes with continued practice.
No. Regulated clinical-data work needs domain knowledge, validation, quality control, traceability and accountable
human review. The module teaches AI as decision support, not as a substitute for professional responsibility.
Always. AI code can contain errors, unsupported assumptions or incorrect transformations, and must be reviewed,
tested and validated before use in a regulated environment.
It is built around workplace workflows — data cleaning, discrepancies, EDC, medical coding, data transfers, QA, database
closure and practical data programming.
Yes. Eligible science, life-science and healthcare graduates can use the programme to build foundational professional
knowledge.
Yes. The programme is delivered online and by distance learning, with a Fast-Track option for those who want to move
quickly.
Course material with the latest updates, online access within 48 hours, printed books shipped with your enrolment, a
personal subject expert for life at no cost, the online examination and project assessment, and two international
certificates on successful completion. There are no hidden charges.
Yes. Every GIHS enrolment now includes complimentary TopCV Coach access worth ₹9,999 for professional resume
building and interview skills, and your profile is posted on the TopCV website where a large recruiter network is active.
Yes, within your lawful professional scope. The Business & Entrepreneurship section of this brochure sets out the nonclinical services, education and consulting work the knowledge supports. Regulated clinical services require the
appropriate qualification and authorisation.
Yes. Any graduate from any discipline may enrol, as can working professionals with relevant experience, entrepreneurs
and managers of healthcare or allied organisations.
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