By Aiden Flynn, CEO at Exploristics
We are regularly approached by growing biotechnology companies for biostatistical support. Often, these companies either have no in-house statistical capability or only a single statistician. Understanding how best to support their needs got me thinking about the pros and cons of bringing statistics in-house in a small biotech.
For a biotech it may seem to make a lot of sense to hire an in-house statistician because it allows the company to:
- Retain control of a critical strategic function
- Maintain oversight of technical activities outsourced to CROs
- Keep costs down as on paper it is less expensive than full outsourcing
- Have constant access to statistical resource
However, while these reasons sound compelling there are downsides to consider too.
Hiring a statistician in-house raises other potential issues that might not have been initially envisaged. For example:
- Recruitment is challenging as there is a need for hands-on experience and strategic support. What type of statistician might be interested? Perhaps one that doesn’t have all the skills and experience, one that doesn’t fully understand the industry
- It may be the intention to build a stats team. However, retention is difficult as it becomes clear very quickly that the statistician is isolated and starts to question what their next opportunity is
- A lack of alignment may develop between career aspirations and the ability of the company to build a statistics function. And if the company does start to build a team, is an experienced statistician without any management experience the right one to build it?
- There is a risk of lack of continuity, loss of knowledge and increased costs if the statistician leaves
- It may be difficult to implement quality management and independent validation of statistical outputs
With so many pros and cons to consider, how do you make the right decision?
Reviewing the role
There is no right or wrong answer as to whether recruiting a statistician is the best thing to do. In some cases, with the right person, it can work very well. However, any biotech company faced with this decision should ask themselves this question- what sort of statistician would be attracted to the role and is that the type of person that you want? Whilst it is possible to find the perfect person who can tick all the boxes, the truth is that this is highly unlikely.
Partnering for growth
Working with a biostatistics consultancy can offer a wealth of expertise that can help make the most of your clinical assets at an early stage of business growth. It can ensure you have the right person for the job at a critical time. When each study could make or break the company, targeted and robust statistical evidence can drive further investment and build confidence. This is a lot of pressure for a single in-house statistician to bear.
A matter of timing
Undoubtedly, it is important at some point in a company’s evolution to bring statistics in-house but to me, it’s all about timing. Companies with assets in early-stage development may find that it is better to partner with a biostatistics-focused company who can provide the range of support and continuity needed. This gives time and space to focus on building the clinical and biological functions as well as identifying partners for other strategic functions and investing in the relationship with them.
Reaching an inflection point
It may be a good time to reconsider building internal statistics functions when you reach a significant inflection point. This could be approval of your lead asset or a fundraising event that supports multiple development programs. At this point, your biostatistics partner can help you build the internal capabilities you really need ensuring that you select the right expertise to support your projects, saving time, costs and recruitment headaches.
As a burgeoning biotech, you will have many plates to spin with limited resources. However, taking time to assess and invest in the company’s biostatistics needs for different stages of growth may be key to ensuring that your biotech flowers.