STATISTICAL PROGRAMMER - Qtech-Sol USA offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Data Management
 
Duration:
15 Weeks / 103 Days
 
 

STATISTICAL PROGRAMMER

Introduction – Statistical Programmer

At Qtech-Sol, our commitment to specialized education and training extends to the realm of Clinical Science, where we recognize the paramount role played by Statistical Programmers. Our comprehensive program is meticulously tailored to cater to the needs of individuals aspiring to excel in this essential role within the dynamic world of clinical research.

In today’s swiftly evolving healthcare landscape, Statistical Programmers hold a pivotal position in ensuring the accuracy, integrity, and compliance of clinical trial data. As clinical research protocols grow in complexity and the demand for robust data management intensifies, there is an increasing need for skilled professionals who can adeptly manage data throughout its lifecycle, from its initial capture to its final analysis.

Our curriculum places a strong emphasis on the critical responsibilities inherent to the role of Statistical Programmers. This includes the meticulous collection, validation, cleaning, and reporting of clinical data. We recognize the pivotal role that Statistical Programmers play in upholding the quality of clinical data, facilitating regulatory submissions, and contributing to the seamless execution of clinical trials.

Our educational program is strategically designed to equip students with the specialized knowledge and practical skills required to excel as Statistical Programmers. We provide comprehensive training on industry-standard tools, data management best practices, and compliance with regulatory guidelines, with a particular focus on utilizing SAS (Statistical Analysis System) software for clinical data analysis.

By enrolling in our program, students gain a competitive edge in securing coveted employment opportunities as Statistical Programmers. They are well-prepared to contribute their expertise to pharmaceutical companies, biotechnology firms, medical device manufacturers, clinical research organizations (CROs), and research clinics.

At Qtech-Sol, we are deeply committed to nurturing the next generation of Statistical Programmers. We invite you to embark on your journey towards becoming a highly skilled and sought-after professional, where your contributions will significantly advance medical research and ultimately enhance patient outcomes. Join us in shaping the future of clinical data management through excellence in SAS programming and data analysis.

Course Name :  Clinical SAS Programmer
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Course Code :  CDOT
Course Material : This course contains and delivers 35 Lessons.

Every lesson encompasses diverse delivery methods, including:

  1. Narrated Presentations: Engaging presentations accompanied by voiceovers to enhance comprehension.
  2. Course Reading Material: Comprehensive chapters designed to facilitate an in-depth understanding of the subject matter.
  3. Practice Quizzes: A set of 15 quizzes to reinforce learning and assess your progress.
  4. Assessment Tests: Ten different test sets to evaluate your grasp of the material.
  5. Short Questions:Succinct questions to encourage critical thinking and quick recall.
  6. Role-Based Tasks: Practical exercises tailored to specific roles, accompanied by detailed solutions for comprehensive learning.
Delivery Type

SIP – Self-Paced Online with Support

Course Duration

CDOT-SIP Delivery – 8 Weeks / 60 Days (Self-Paced)

Introduction

A Statistical Programmer holds a crucial position in the realm of clinical research, playing a pivotal role in managing and analyzing clinical trial data associated with pharmaceutical and biotechnological products, medications, and medical procedures. Their responsibilities encompass a diverse range of tasks that are instrumental in ensuring the accuracy, integrity, and compliance of clinical data:

  1. Data Extraction and Transformation: Clinical SAS Programmers are responsible for extracting raw data from various sources, transforming it into usable formats, and loading it into secure databases.
  2. Data Validation and Quality Control: They meticulously validate and quality-check the data to identify and rectify discrepancies, errors, or inconsistencies, thereby maintaining data integrity throughout the study.
  3. Statistical Analysis: Collaborating closely with biostatisticians and researchers, Clinical SAS Programmers perform statistical analyses to derive meaningful insights from the clinical data. They generate statistical reports and graphical representations to aid in decision-making.
  4. Programming and Scripting: Utilizing SAS (Statistical Analysis System) software, they write and implement customized programs and scripts to manipulate and analyze large datasets, ensuring data accuracy and reliability.
  5. Data Visualization: They create visual representations of data, such as graphs and tables, to facilitate data interpretation and presentation, which is essential for regulatory submissions and scientific publications.
  6. Protocol Adherence: Clinical SAS Programmers adhere to study protocols, regulatory guidelines, and industry best practices, ensuring that data management and analysis align with established standards.
  7. Documentation: They maintain meticulous documentation, including data management plans, program codes, and standard operating procedures (SOPs), to ensure transparency and reproducibility of data analyses.
  8. Database Maintenance: Overseeing the design, implementation, and maintenance of secure and compliant data management systems and databases to ensure data security and confidentiality.
  9. Regulatory Support: Assisting in the preparation and submission of regulatory documents and datasets for approvals and inspections by regulatory authorities.
  10. Collaboration: They work collaboratively with cross-functional teams, bridging the gap between the study’s sponsor and clinical sites, to maintain the transparency and integrity of clinical trial results.

To excel in the role of a Clinical SAS Programmer, an individual must possess exceptional attention to detail, a strong educational background, and effective communication skills. Their dedication to upholding the highest standards of research ethics, data integrity, and protocol adherence is paramount to the successful execution of clinical data analysis. Through their contributions, Clinical SAS Programmers play a pivotal role in advancing medical science and ultimately improving patient outcomes.

Course Enrollment process

Qtech-Sol offers a flexible approach to learning through our self-paced online courses. Students have the freedom to commence their studies at their convenience, following a straightforward process.

  1. Member Registration: Begin by registering as a member of our platform
  2. Course Selection: Explore and choose the course that best suits your needs and goals.
  3. Enrollment and Tuition: Complete the enrollment process and make the necessary tuition payment.
  4. Access Learning Materials: Access course materials and resources through our Learning Management System (LMS).
  5. Support and Assistance: Receive support and assistance via email or schedule Google Meet sessions through the LMS.
  6. Course Task Submissions: Submit course-related tasks and assignments as per the provided schedule.
  7. Final Examination: Upon finishing the course, take the final examination to demonstrate your understanding.
  8. Course Completion: Upon successful completion, receive a course completion certificate and a transcript.
  9. Post-Training Support: Take advantage of our post-training support for assistance with resume building, narrative development, and mock interviews.

This step-by-step process ensures a smooth and flexible learning experience, allowing you to acquire valuable skills and knowledge at your own pace.

Building Relevant Experience

When aspiring to embark on a career as a Statistical Programmer, educational qualifications hold significance. While a bachelor’s degree in life sciences or a related health discipline is often the ideal foundation for this role, it’s noteworthy that certain entry-level positions within the realm of Clinical SAS Programming, such as Data Entry Specialists or Data Technicians, may require only an associate degree or, in certain instances, a high school diploma.

At Qtech-Sol, our training program for Statistical Programmers places a strong emphasis on computer-based roles that leverage clinical data and cutting-edge tools to support ongoing clinical trials. Thus, possessing a fundamental understanding of basic computer applications such as Microsoft Word, Excel, Notepad, and PowerPoint is paramount for success in this profession.

The exemplary candidate for roles in Clinical SAS Programming typically boasts a background in pharmaceuticals, healthcare, or research centers, including hospitals. Our program provides intensive training in the core responsibilities undertaken by Statistical Programmers, where these professionals are entrusted with overseeing the collection, validation, and management of clinical trial data. They ensure the data’s accuracy and compliance with stringent regulatory standards. As part of our program, students gain invaluable exposure to real-world practices and case studies, covering critical areas such as clinical data capture, database design, data validation, data cleaning, clinical data audits, and the intricate process of database locking.

Furthermore, students gain insights into industry-standard practices, including Good Clinical Data Management Practices (GCDMP), adherence to Clinical Data Interchange Standards Consortium (CDISC) standards, familiarity with regulatory guidelines issued by esteemed entities like the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and a deep understanding of Standard Operating Procedures (SOPs) governing data management within the realm of clinical trials.

Upon successfully completing our program, individuals are well-prepared to explore a multitude of job titles within the domain of Clinical SAS Programming, including but not limited to:

  1. Statistical Programmer
  2. Data Analyst (SAS)
  3. Clinical Data Analyst (SAS)
  4. Statistical Programmer
  5. Biostatistical Programmer
  6. Clinical Database Programmer
  7. SAS Programmer Analyst

Our comprehensive training program equips aspiring professionals with the essential skills and knowledge required to excel in the dynamic and mission-critical role of Clinical SAS Programming. Here, meticulous data handling is the linchpin for the success of clinical trials and the continual advancement of medical science, ultimately impacting the lives of patients worldwide.

Educational Requirements:

Preferred Qualifications: In our pursuit of nurturing adept Statistical Programmers, we recommend candidates to hold an associate or bachelor’s degree in specific fields that provide a strong academic foundation. These chosen majors or related fields equip individuals with essential knowledge and skills highly relevant to the role of a Statistical Programmer. Eligible majors encompass a diverse range of disciplines, including:

Statistics: A degree in Statistics equips individuals with a solid grounding in statistical methodologies, which is fundamental for effective data analysis.

Biostatistics: This major specializes in applying statistical methods to the realm of healthcare and life sciences, aligning perfectly with the requirements of clinical data analysis.

Computer Science: Computer Science programs offer valuable expertise in programming languages and data manipulation, which are pivotal for SAS software utilization and data analysis.

Bioinformatics: Bioinformatics combines biology, computer science, and statistics, making it highly relevant for the management and analysis of biological and clinical data.

Mathematics: A degree in Mathematics provides a strong mathematical background, a critical asset for performing statistical analysis and programming tasks in clinical data management.

Pharmacy: Pharmacy majors offer insights into drug development and healthcare, particularly valuable for those interested in clinical trials related to pharmaceutical products.

Life Sciences: Majors such as Biotechnology, or Pharmacology in the Life Sciences domain provide domain-specific knowledge that synergizes well with data analysis skills.

Clinical Research: Majoring in Clinical Research imparts an in-depth understanding of the clinical trial process and regulatory intricacies, aligning directly with clinical data management roles.

Public Health: Public Health programs encompass courses in epidemiology, biostatistics, and data analysis, providing vital skills for clinical data management.

These chosen educational backgrounds establish a sturdy platform for individuals aspiring to pursue a fulfilling career as Statistical Programmers. They not only offer pertinent insights and expertise directly applicable to the field of clinical data analysis and management but also ensure that candidates are well-prepared to excel in the dynamic and critical role of Clinical SAS Programming. While possession of one of these preferred qualifications is encouraged, we also value inclusivity and recognize the unique contributions of applicants with equivalent degrees or relevant experience, fostering a diverse and enriching learning environment within our program.

Support After Training:

Your resume is often the first impression you make on recruiters and potential employers. In today’s competitive job market, it’s crucial to ensure that your resume meets industry standards and effectively represents your qualifications. That’s where our Post-Training Assistance (PTA) program comes in.

Our PTA program offers valuable assistance in resume building, interview preparation, and mock interviews. It’s not just about creating a strong resume; it’s also about understanding the current job market in your area, identifying available positions, gauging salary ranges, and ensuring that your resume aligns with your career goals. During the PTA program, you’ll have the opportunity to engage with our course specialists, taking small but meaningful steps toward your professional success. We’ll work together as a team to help you achieve your career objectives.

   Key Learning Outcomes and Benefits for Students:

  1. Enhancing the knowledge and skills required for your field.
  2. Improving your resume to increase your chances of landing promising job opportunities.
  3. High-value learning at an affordable cost.
  4. Flexibility to learn from anywhere, at your own pace.
  5. Practical tasks aligned with real-world industry practices and job roles.
  6. Application of concepts in real-time scenarios, including policies, governance, and industry tools.
  7. Engaging in role-based tasks commonly practiced in the industry.
  8. Preparation with mock interviews and interview narratives for effective client discussions.
  9. Readiness to work with minimal support, boosting your confidence in your chosen field.
Professional Organizations and Associations:

As a dedicated SAS Programmer, active participation in relevant professional organizations and associations is not only advisable but instrumental in your career growth. These specialized groups cater to the unique needs of SAS Programmers and offer an array of valuable benefits. By becoming a member, you gain access to invaluable networking opportunities, a treasure trove of essential resources, and insights generously shared by fellow SAS experts. Your involvement in these associations will not only keep you connected with like-minded professionals but also keep you updated with the latest trends and innovations within the SAS programming domain. The collaborative environment fostered by these organizations can significantly enhance your knowledge, boost your career prospects, and establish meaningful connections within the SAS programming community.

Stay Informed:

In the ever-evolving landscape of SAS programming, staying well-informed is not merely an option; it’s a necessity. Capitalize on global clinical resource information sources to ensure you remain at the forefront of the latest news and developments across various facets of your profession. Regularly delve into updates pertaining to SAS programming, statistical analysis, regulatory compliance, and pharmacovigilance. Being well-informed about industry advancements and best practices is not only conducive to your professional growth but also empowers you to make informed decisions that positively influence the quality and efficiency of your SAS programming endeavors. Your commitment to staying informed will not only enhance your expertise but also contribute significantly to the success of clinical data management in your career as a SAS Programmer.

Overview of the Curriculum

Our program is intricately crafted by industry experts, with a primary focus on meeting the precise educational requirements and skill development needs of students and emerging professionals who aspire to excel as Statistical Programmers. This comprehensive training program empowers participants with a profound understanding of the roles and responsibilities inherent to Clinical SAS Programming positions.

The curriculum we offer encompasses both theoretical and hands-on practical components, ensuring a holistic learning experience. Participants gain valuable insights into the intricacies of day-to-day tasks, and they are exposed to a range of industry-specific exercises designed to enhance their skills and knowledge. Our program is finely tuned to prepare individuals for the dynamic and demanding field of Clinical SAS Programming, providing them with the expertise required to excel in this vital role within the clinical data management landscape.

Statistical Programmer – Lessons Offered

Our Clinical SAS Functional Programming program is meticulously designed to provide students and professionals with comprehensive knowledge and hands-on skills necessary to excel in the role of a Statistical Programmer. The curriculum covers a wide array of topics, encompassing both foundational SAS concepts and advanced clinical trial-specific content.

Foundational SAS Concepts:

1. Elementary SAS Concepts

2. SAS Efficiency Programming

Clinical Trial Fundamentals:

3. Introduction to Clinical Trials

4. Types and Data in Clinical Trials

5. Clinical Trial Protocol Development

6. Elements of CRF Design

7. Electronic Data Capture (EDC)

8. Good Clinical Practices

9. Good Documentation Practices

10. Workflow Instruction Request

11. Documentation Templates

Data Validation and Statistics:

12. Introduction to Data Validation

13. Data-Based Validation

14. Protocol-Based Validation

15. Basics of Statistics

16. Statistical Analysis Planning

17. Elements of Hypothesis Testing

Efficiency and Data Reporting:

18. Basics of Efficiency

19. Integrated Summary of Effectiveness (ISE)

20. Integrated Summary of Safety (ISS)

21. Clinical Data Interchange Standards Consortium (CDISC)

22. Preparing Analysis Data Sets

23. Creating Tables, Listings, and Graphs (TLG)

Therapeutic Areas and Projects:

24. Understanding Various Therapeutic Areas

25. Data-Based Therapy

26. Introduction to Phase I Studies

27. Oncology Project

28. Introduction to Phase II Studies

29. Ophthalmology Project

30. Introduction to Phase III Studies

31. Cardiology Project

32. Introduction to Phase IV Studies

33. Central Nervous Systems (CNS) Project

Pharmacovigilance and Reporting:

34. Introduction to Pharmacovigilance

35. Pharmacovigilance Reporting

Job-Focused Exercises

In addition to comprehensive lessons, our program includes practical exercises that align with job-specific tasks and challenges faced by Statistical Programmers. These exercises enhance participants’ proficiency in key areas such as data validation, hypothesis testing, therapeutic area projects, CDISC standards, efficiency programming, and aggregate reporting.

By completing our Clinical SAS Functional Programming program, participants gain the knowledge and hands-on experience needed to excel in the dynamic field of clinical data management and SAS programming. This curriculum equips them with the essential skills required to navigate complex clinical trials and contribute to advancements in medical research.

Getting in Touch:

For more information, please call us at +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email qpdc@qtech-solutions.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.