This apprenticeship offers candidates the chance to rapidly develop expertise in patient data management, analysis and reporting for clinical trials. It's an intensive learning experience aimed at those who are ambitious and ready to tackle the challenges of achieving high proficiency in this critical field. The eligibility requirements outlined in subsequent sections are subject to change based on the current job market needs. After submitting your application, our team will evaluate your qualifications and, if you meet the criteria, you will have a meeting with our admissions director to address any remaining inquiries and finalize the assessment. If accepted, you will be provided with a registration link to access the Pre-Apprenticeship program.

Upon acceptance, you are invited to explore our virtual HQ at any time before Orientation Day, which will take place on-site in Pittsburgh. Within the virtual HQ, you will the opportunity to review technical papers in our file share and interact with specialists on our forum. Although attending our virtual sessions is not mandatory prior to the apprenticeship, they are provided early to give you confidence as you commence the Apprenticeship program.

To complete the program, participants must obtain three certifications and prepare four Clinical Study Reports (CSRs). The certifications, increasing in complexity, are: SAS Base Specialist, SAS Advanced Programmer or SAS Clinical Trials Programmer, and CDISC Tabulate.
 

1. SAS Base focuses on essential SAS programming skills, including data manipulation and basic statistics, paving the way for advanced topics like PROC SQL, PROC REPORT, and SAS Macros.
    

2. The SAS Clinical Trials Programmer certification involves using SAS for clinical research tasks, such as data validation and report generation in compliance with regulatory standards.
    

3. The CDISC Tabulate certification deals with the application of CDISC SDTM standards to ensure the organization, consistency, and regulatory compliance of clinical trial data.
    

Each certification equips professionals with the necessary skills to manage clinical trial data efficiently and adhere to industry standards.  The apprenticeship period contextualizes the exam content within clinical trials, enabling further preparation and the opportunity to rank among the highest for the combined score.

​Adherence to regulatory guidelines, good clinical practices (GCP), and internal Standard Operating Procedures (SOPs) is essential to ensuring the integrity and validity of the clinical study data and the resulting Clinical Study Report (CSR). 

During your apprenticeship, you will:

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1. Plan and Design: Understand study goals, endpoints, and statistical plans. Work with clinical teams to ensure data collection meets regulations.

2. Data Collection: Oversee data gathering from clinical sites, ensuring accuracy using electronic systems.

3. Data Cleaning and Validation: Clean and validate collected data, spotting errors and resolving them.

4. Statistical Analysis: Conduct analyses following the plan, including safety and efficacy assessments. Verify program accuracy.

5. Results Interpretation: Interpret results considering study goals. Assist in drafting statistical sections of the CSR.

6. CSR Writing: Contribute to CSR writing, describing methods, summarizing results, and ensuring compliance with guidelines.

7. QC and Review: Perform thorough QC checks on the CSR for accuracy and consistency with plans.

8. Regulatory Submission: Prepare the CSR for submission to regulatory agencies like the Food and Drug Administration (FDA).

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Study sponsors invite Apprentices who have completed clinical study reports (CSRs) to participate in interviews. This practice is comparable to addressing queries or requests from regulatory agencies, such as the FDA's information requests (IR), by providing necessary clarifications and additional analyses. It serves multiple beneficial purposes for both sponsors and apprentices of the program:

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Firstly, sponsors want to inspect the apprentices' study documents, including programs, datasets and logs, to audit the methodology and results of the CSRs. Secondly, emulating a scenario akin to FDA inquiries ensures that the interview process is systematic, transparent, and, most-of-all, representative of what the Apprentice will actually be called to do on-the-job.

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Due to this structured and practical approach, interviews that do not culminate in job offers still provide valuable learning experiences, potentially leading to opportunities in the future.