What do medical statisticians and statistical programmers do?

Clinical trial design

Every new medicine that is invented must be thoroughly tested to prove that it is not only an effective treatment for a health problem, but that it is safe for patients and does not have any side effects that are too severe.

We do this by conducting clinical trials where patients are administered the experimental new treatment and are compared to a control group of patients administered a placebo or an existing treatment.

Medication

Collaborate in teams

Before we go ahead and give patients treatments, we need to make sure that we have robustly designed our trial to give us the best chance of being able to demonstrate that the experimental new treatment is superior to the comparator control treatment.

Designing and conducting a clinical trial requires expertise from a wide range of professions, so statisticians and programmers get to enjoy working in cross-functional teams comprising medics, study managers, data managers, regulatory experts, and many more.

Their skills in maths and statistics allow them to make very valuable contributions to the clinical trial. Explore below just some of the activities they do in their day to day jobs.

Shaking Hands

Medical Statisticians


The statistician has some very important jobs to do when designing a clinical trial. To start with, they must calculate how many patients are needed for the trial. We call this the sample size.

Calculate sample size

Climbing Staircase

If we treat too many patients then we risk exposing an unnecessary number of patients to an inferior treatment.

If we treat too few, then we risk not having enough evidence to prove that the new treatment is superior.

This is a critical calculation on which the success of the trial and many millions of pounds lie.

Randomise patients to treatment

It is the statistician’s job to allocate patients to the new treatment or to the placebo or control treatment. Treatments must be allocated at random so that the two groups are similar in every way except for the treatment they are given.

You can do a simple randomisation by tossing a coin and assigning all those who get a head to the control group and all those who get a tail to the new treatment group.

Choose appropriate analysis methods

Statisticians have a crucial job to make sure that data collected during the clinical trial is analysed using appropriate methods and is interpreted correctly.

They carry out statistical tests to weigh the evidence held in the data and determine whether the new drug is beneficial for patients.

Formula

Key skills

As well as their statistical qualifications, statisticians need to have good communication skills. They must interpret the results of statistical analyses and explain to non-statisticians, such as the medical team, what the results mean in layman’s terms.

Statisticians are often called upon to give input to decision-making. Their logical thinking and understanding of the whole clinical trial from data collection to analysis results is very valuable.

Statistical programmers


Statisticians and programmers work very closely together. In fact, in some companies these are not two separate jobs. Both need to be proficient in programming languages such as R and SAS.

Create datasets

The programmer makes sure that the data is ready to be analysed. This can include calculating new 
Programming
measurements, called endpoints, from the data already collected. For example, if we know the date on which a patient fully recovered, then we can calculate time to recovery (number of days from the start of the trial to the date of recovery).

Summarise Data

Programmers are experts in turning datasets into summary tables and graphs. The statistician and programmer collaborate to decide how the tables and graphs should look and what they should contain, and then the programmer makes these a reality.

Key skills

Programmers need to be skilled in paying attention to detail and they must carefully document their work so that analysis results are traceable from the raw data. Programmers must also be very organised and able to meet deadlines.

Boxplots

 

Check out the Next Steps page to find out how you can study and train to be a medical statistician or statistical programmer.

EventsFuture Events


  • PSI Webinar: Adaptive design: updated draft FDA guidance and its implications - Dates: 11 – 11 Jun, 2019

    In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
  • Adaptive Designs - Dates: 24 – 24 Jun, 2019

    During this meeting we will hear about adaptive sample allocation for phase II/III designs, a new CONSORT extension reporting guideline for adaptive designs, regulatory aspects and case studies.
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