The role of a statistical programmer can be challenging and rewarding, with opportunities for technically minded people.

PHUSE conducted an interview with Parag Wani, Principal Statistical Programmer at Novo Nordisk, to share their story and illustrate the wide spectrum of profiles finding their way into the role of a statistical programmer in the pharmaceutical industry.

1. What made you want to be a statistical programmer?

Based on my academic background in computer science, programming was something that I always had a very keen interest in. Whilst I was still studying, there was a high demand for programmers in different domains. Honestly speaking, my entry to the statistical programming world in the pharmaceutical domain was quite unplanned. My first break was with Pfizer, where I was offered a position through university placement. I had no prior experience with SAS or clinical data analysis and reporting, but since it was a very niche area back then, I decided to give it a go. Once I started off, I realised that there is a lot more to this profile than just programming.

Also, the impact of my work in the drug development value chain, which brings medications to patients, is a very satisfying feeling at the end of the day. I feel like I can make a difference. It makes you feel proud. You need to be really lucky and privileged to contribute to a process that touches so many lives in a positive way. The opportunity to constantly learn and interact with skilled stakeholders made me more inclined to pursue this career as a statistical programmer.

2. Can you provide us with an insight into your career journey so far?

I completed my master’s in computer science and was fortunate to begin my career at Pfizer, India, in 2005, where I had my first exposure to the world of SAS and analysis and reporting of clinical trials. I was responsible for a lot of work in population PK-PD. In 2007, I joined a global CRO – i3StatProbe, currently known as Syneos (formerly inVentiv), where I had the opportunity to work across multiple sponsor portfolios. From a learning perspective, this was a great opportunity as it involved adapting to various client needs and working across multiple therapeutic areas. Working for a CRO was very different to working with a sponsor. This was also the phase where a lot of companies were moving or migrating into CDISC, so there were a lot of development opportunities. In 2011, I joined Cognizant, as I wanted to try something different. My role involved project and people management along with operational hands-on responsibilities. I was also able to contribute to business development, which provided me with insights into RFPs/RFIs, resourcing strategies and negotiations.

In early 2014, I relocated to Singapore to work with Singapore Clinical Research Institute, an academic research organisation and a wholly owned subsidiary of the Ministry of Health, Singapore. I had the opportunity to work on research collaborations between academia and pharmaceutical, device and biotech companies.

I have been at Novo Nordisk in Denmark, since 2015, when I began as a trial programmer the Haemophilia portfolio. Following that, I worked with the Biostatistics Centre of Expertise, which is responsible for aligning standards and other tasks that have an impact across all projects. I am now an international lead programmer for the NASH therapeutic area. I am also a member of the programming expert group and the ADaM global standard team at Novo Nordisk.

3. What were some of the challenges you faced when starting out in the industry?

As with any other industry, the first challenge for me was understanding the domain; clinical drug development and the importance of industry regulations. It was challenging to adapt to and understand different therapeutic areas, since the way I needed to focus on data depended upon the kind of therapeutic area I was working with.

Another challenge, especially coming from an IT academic background, was understanding the nuances of communication and collaboration across skill areas. Working with a variety of functional skill areas, such as trial operations, data management, biostatistics, medical and regulatory, can be challenging. Thankfully, I enjoy collaborative work environments and have good stakeholder management skills, so I was able to adapt quite easily.

4. How does your role add value to the drug development process?

Statistical programmers play a pivotal role in the drug development process. Towards the end of the data value chain, they are responsible for analysing data and translating it into meaningful information in the form of outputs. The overall contribution of a statistical programmer in the drug development process is a lot more. It includes providing technical inputs in terms of what or how data is collected, ensuring adherence to various regulatory requirements and data standards, and preparing submission-ready datasets, outputs, and other documents. Drug development is a long-running complex process, and apart from the primary trial-related programming tasks, a statistical programmer is responsible for various exploratory tasks, ad hoc programming requests for regulatory authorities, preparing safety updates and providing stakeholders with data insights.

Finally, new age statistical programmers do not limit themselves to traditional programming tasks. Bringing in an agile and transformational mindset, they are now pushing boundaries of their responsibilities, adding immense value to optimising the drug development process.

5. What excites you the most about the future of your career?

I honestly feel that this is one of the most exciting times to be a part of this domain. We all know that the entire landscape in our industry is transforming. During the current pandemic, we all have seen that seemingly impossible targets are achievable and there are new ways of working and collaborating that every organisation is striving to incorporate. Within Novo Nordisk, we have already embarked on a transformative journey, driven by innovations, digitalisation and embracing an agile culture. There is a lot more focus on the role of a statistical programmer. Contributions that we can bring to the table are not limited or driven by traditional tasks, and it is very evident throughout the industry that there is exponential growth in new processes, tools and solutions. The increasing complexity of trial designs, new ways of data capture, evolving standards and regulatory requirements, focus on real-world data, ongoing and retrospective insights into data, automation – all these definitely point towards a very exciting future for my career path.

6. Where can a career as a statistical programmer take you?

As a statistical programmer, there is always a lot to learn – different therapeutic areas, different requirements, evolving standards. You can aim to specialise in the role and move from being a contributor on individual trials to a more cross-project architect of solutions and processes. For a couple of years at Novo Nordisk, as a part of the Biostatistics Centre of Expertise, I did exactly that. When you start leading projects, and working with a team of programmers, you also inculcate a lot of leadership qualities. So, the option of progressing into a leadership role also exists if you have the inclination for it.

7. What do you think are the key skills you need to be successful in in your role?

Apart from being technically and analytically proficient and having keen data insights, first and foremost is the overall scientific understanding of the specific therapeutic area. It is also very important to have an innovative mindset and awareness of the technical interdependencies of data flow in the value chain.

8. And what skills other than technical skills do you think are important?

Process understanding, stakeholder management, efficient collaboration and communication skills, attention to details, ability to adapt and change.

9. What advice would you give to someone starting in your industry?

I think the learning curve is quite steep, though it depends on the person’s background. Whether it’s academia or a different industry, the first important thing is to understand the clinical domain, regulatory requirements and ICH, GCP guidelines.

It is also highly recommended to get familiar with data standard requirements, especially SDTM and ADaM models, then computing environments, programming tools and code repositories and other technical aspects. Some advice for newcomers is to make sure that the clinical data they are working with is always the key focus. Of course, it helps by looking at the protocol and CRFs on how, when and what needs to be collected, but there are always unforeseen things in data that require a lot of attention when creating datasets or doing analysis. It is also very important to understand the upstream and downstream skill areas involved.

10. What is one interesting fact about statistical programmers that people on the outside may not know?

We are not IT support! And we have nothing to do with troubleshooting computer problems. Jokes aside, explaining what we do as statistical programmers to someone outside our industry is not the easiest task. We are involved in a lot more than just programming.

If you enjoyed Parag's blog and would like to connect with them further on LinkedIn, do so here.