Silva Tommasini_Career Insights_Principal Statistical Programmer

In this blog of ‘Career Insights’ series we talk to Silva Tommasini, Principal Statistical Programmer of CROS NT, to find out more on her career path, achievements, current role at CROS NT and her interests outside of work.

Silva Tommasini Principal Statistical ProgrammerHow did you realise that statistical programming would be the right career for you?

One day a university professor presented the Faculty of Statistics at my school. I remember I was so fascinated by his explanation of probability and the Gaussian curve that I decided to enrol in the Faculty of “Statistics and Demographics”. After obtaining my degree in statistics I spent 20 years working as statistician in a pharmaceutical company. There I was responsible for a wide number of studies, mostly in the malaria field, but also in other therapeutic areas including cardiovascular and neurological diseases. We were a small team, so the statisticians not only wrote the statistical sections of the Study Protocols and prepared the Statistical Analysis Plans, but also were responsible for the generation of the TLFs of the CSRs.

This is when I realised how important the SAS programming is. It allows to generate the tables, listings and figures that are crucial for reaching the trial objectives. I also realised that I enjoyed writing SAS programs and optimising the SAS code to obtain ‘pretty and informative’ tabulations. It is exciting to be able to generate outputs that best summarise the data and allow you to draw conclusions on them.

What has been your journey to your current role at CROS NT?

As I have previously mentioned, I had been working as a statistician for about 20 years in a pharmaceutical company. For 17 years I had been working in R&D on the statistical analysis of clinical data. Then I moved to the Pharmacovigilance department of the same Company to ensure epidemiological and statistical expertise for the Post Authorisation Safety Studies, PSUR preparation and other pharmacovigilance needs. During these 3 years, I have been programming a suite of SAS macros for signal detection, safety surveillance meetings and PSUR preparation, and once again I realised the importance of the work of the statistical programmer. It allows to speed up the physician’s review of the data, preparing the necessary outputs.

What has been the most interesting project in your career so far?

In the past I worked for many years in a project for the development and registration of an antimalarial drug for uncomplicated malaria. After a lot of work and analyses the drug achieved market authorisation in Europe and it was introduced in malaria endemic countries for the benefit of the patients. It was a very long journey during which we had audits and many requests from the Regulatory Authority, but we did our best and we achieved the result! It was a great satisfaction!

What are the top skills that a statistical programmer should develop?

In my opinion the top skills are proactivity and strive to standardise.

As for proactivity, I think it is particularly important to interact with the study team when you think that specifications do not reach the objective or can be improved. It means to anticipate possible problems in order to find good and timely solutions.

On the other side, a statistical programmer should always look to standardise and ensure CDISC compliance, because this improves the quality of the SAS programs, reduces time needed for programming and ensure consistency among studies.

What most inspires you about working within the Life Sciences field?

Positive study results always let you think to have contributed in some way to the improvement of patients’ lives. This is very inspiring and gives me a lot of motivation: it is great to realise that we are part of a bigger process that brings medicines and treatments to the patients.

What would be your top tips for early-career specialists looking to develop in statistical programming?

My top three tips are:

  • Always be curious, read regularly latest industry news on the web and start your work by using the programs written by others as much as possible. This allows you to improve your skills, as well as to have more time for the details… which I think makes the difference between good and great.
  • Never forget to document your code for the programmers who will look at them after you.
  • Never rush and always take time to quality check your results before delivery.

How do you think the role of statistical programmer will evolve in 2021?

I like to think that the statistical programmers will have the opportunity to follow their specific interests and become specialised in a range of areas. This would lead to improved efficiency, which is always our primary objective.  An area which is rising in importance is data visualisation because it supports decision making in clinical trials. Other important areas are the SDTM and ADaM programming, which are mandatory for FDA submissions. I think that the expertise in these areas will be highly appreciated in the future.

What are your personal values?

Firstly, I am passionate about my work. I always think positive and I never give up, doing my best to comply with the study timelines. Teamwork and proactivity are the values in which I mostly believe. People usually says that I am always smiling. It is true. I noticed that usually people answer with another smile…and the day starts better!

What are your main interests outside of work?

After my family there is an amateur choir where I sing as Alt, in Rome. We are a group of about fifty who sing polyphonic pieces of the most famous composers of Sacred Music. I really think that being in a choir let you always feeling better. I like to think at the choir as at a ‘special work’ where you reach the result only if you all help each other.Silva Tommasini Principal Statistical Programmer


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