Meet the Expert: Robert Rachford

March 21, 2024

Meet the Expert: Robbie Rachford

This blog post has been updated since its original published date: March 21, 2024.

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.

Meet Robert Rachford, Vice President, Biostatistics and Statistical Programming

What do you do at ProPharma? How does your role support our higher purpose of improving the health and safety of patients?

As the Vice President of Biostatistics and Statistical Programming at ProPharma, I oversee and am responsible for our global biostatistics and statistical programming teams. Specifically, our division provides a multitude of services related to the collection, management, analysis, and reporting of life sciences data.

Our division supports ProPharma’s mission of improving patient health and safety through the careful and comprehensive analysis and reporting of clinical trials. At the end of the day, when a health authority looks to make a decision around approving a new drug or therapy, they look very closely at the clinical trial data and the statistical analysis and summaries to determine if the new treatment is truly effective and safe. We are the division that helps tell the story of the clinical data and enables regulators to make well informed decisions on which therapies to approve and which to reject.

In addition to leading the biometrics team at ProPharma, I have also been able to leverage my data analytics and Large Language Model (LLM) background and experience to help develop a large suite of new AI and data visualization tools we are calling the Prodigy suite. These tools include a comprehensive data visualization tool enabling our clinical teams as well as our sponsors to view and analyze their clinical trial data in near real time, generate the first draft of patient narrative reports at the push of a button, and extract and summarize all questions asked by regulators during a submission. They help both our internal teams as well as our clients, work more efficiently and effectively towards new product approval.

Tell us about a day in the life of a Biostatistician and a Statistical Programmer.

Imagine the Biostatistician as the visionary architect behind the intricate analyses and comprehensive summaries that illuminate the path of a clinical trial. Much like an architect who drafts the blueprint for a building, the Biostatistician meticulously designs the study protocol and statistical analysis plan, ensuring the foundation is solid for what will eventually become the completed study report. The Statistical Programmer, in this analogy, embodies the skilled builder. They take the architect's blueprints—confirming and clarifying the details with the Biostatistician as necessary—and brings them to life by developing the study datasets and outputs. 

On a day-to-day basis, our Biostatisticians and Statistical Programmers collaborate closely, not only with each other but with a broader team of clinical trial professionals, including Project Managers, Data Managers, Medical Monitors, and Medical Writers. This multidisciplinary teamwork is pivotal in designing, developing, reviewing, and publishing clinical trial reports that advance the life sciences industry and contribute to the introduction of innovative therapies and products into the market.  

Specifically, our Biostatisticians are responsible for creating comprehensive and robust statistical analysis plans. Following this, our Statistical Programmers craft regulatory-compliant datasets and outputs based on these plans. These outputs undergo a thorough review by the Biostatisticians for accuracy and completeness before being shared with our clients and, ultimately, regulatory bodies for approval. 

This integrated approach ensures that every aspect of the clinical trial is aligned and optimized for success, reflecting a seamless partnership between Biostatistics and Programming teams and across all functions involved in the trial. This collaborative environment not only enhances the efficiency and quality of our work but also ensures that we remain at the forefront of bringing groundbreaking medical advancements to the community. 

Describe the biggest challenge facing our clients/industry today. How are we addressing this?

Today, the life sciences industry has more data than ever before. This is a GREAT thing, however, data is meaningless unless it is analyzed and summarized correctly. Our team cannot only help analyze and summarize our clients’ clinical and non-clinical data, but we can also help our clients determine how to best use their data. We do this by listening to and understanding our clients’ goals and objectives. We then review their available data and data collection strategies from an analytical perspective to see how the data can be used to achieve their identified goals and objectives. As big data in the life sciences becomes the new normal, our biostatistics and programming team at ProPharma is well positioned to assist our clients by deriving meaningful and impactful insights from their data.

Tell us a little bit about yourself outside of work. 

Outside of ProPharma, you will see me in one of two places: I am either doing something with my family, or I am posting educational material on LinkedIn. As a family, I have an amazing wife, an incredible daughter who is two and half and is a MASTER negotiator, and the best dog anyone could ask for (he’s a Samoyed and is VERY fluffy), you can usually catch us in our kayak (dog included) or on some sort of adventure out into nature. On LinkedIn, I am typically posting and sharing content to assist non-statistically trained life sciences colleagues make sense of statistics with the goal to lift life sciences research everywhere. With better statistics, we have better clinical trials, and with better clinical trials, we have better patient health and safety.

What value does a client gain by working with ProPharma’s Biostatistics and Programming experts?

ProPharma stands as a comprehensive powerhouse within the life sciences spectrum, offering an expansive array of services that stretch from the inception of target discovery and validation through to the intricate layers of post-market analysis. This breadth of expertise ensures that when clients choose ProPharma, they gain more than just a service provider; they secure a strategic ally capable of not only devising robust strategies but also flawlessly executing them. This integration of strategic planning and execution under one roof eliminates the risk of knowledge dilution typically encountered during the handover process between separate entities. Our clients benefit from a seamless transition from strategic development to operational execution, safeguarding the integrity and momentum of their projects.

Moreover, ProPharma's prowess is not confined by geographical boundaries or regulatory jurisdictions. Whether our clients are preparing for submissions to the FDA, MHRA, EMA, PMDA, or any other regulator, our team of global experts is adept at navigating the complex regulatory landscapes across the world. Our biostatisticians, who specialize in crafting phase 3 protocols—from endpoint determination to sample size calculations—ensure that once a design is finalized, there's no need to seek external vendors for implementation. This continuity not only streamlines the process but also fortifies the strategy's execution, regardless of the regulatory body in question. Thus, partnering with ProPharma means entrusting your vision to a team that not only conceives and plans your route to success but also walks it with you, ensuring global regulatory compliance every step of the way.


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