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The Analysis of Direct and Indirect Pathways in Observational Studies

Statistical Consultancy Team

The blog was orginally presented by one of our statistical consultants at the Statisticians in the Pharmaceutical Industry (PSI) 2017 conference.

Inflammatory rheumatic diseases, such as ankylosing spondylitis (AS), are a major cause of work disability. Despite clinical progress in inflammation control and associated improvements in outcomes, work disability remains an issue for AS patients, and other underlying causes, such as fatigue, have been postulated. We have used data from an observational study, which followed a large cohort of AS patients in routine clinical practice for 12 months, to investigate the longitudinal relationship (data at baseline, 6 and 12 months) between fatigue and work disability in the presence of other recognised confounders. Initial results suggested possible inter-relationships between the effects of fatigue and anxiety/depression, leading to a post-hoc hypothesis that:

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Topics: Biostatistics Consulting, Statisticians in the Pharmaceutical Industry (PSI), SAS Macros, Statistics, Observational Studies, Inflammatory Rheumatic Diseases, PROC GENMOD

Is a MSc in Statistics the ‘be-all and end-all’ to a career as a pharmaceutical statistician?

Statistical Consultancy Team


The vast majority of pharmaceutical companies and Clinical research organizations (CROs) ask for an MSc in Statistics (or Medical Statistics) when hiring statisticians, claiming these degrees in particular provide adequate preparation and the necessary hands-on experience to work in the industry. However – how strict is this rule across different companies, and should this be a requirement? Can similar qualifications such as an MMath or PGDip (which can have a lot of crossover with traditional statistics MScs) be equivalent and provide the required statistical training for a successful career in industry? Or can a BSc be sufficient? I aimed to answer these questions by asking senior statistical leaders and recruiters for their views through 4 questions.

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Topics: Statisticians in the Pharmaceutical Industry (PSI), Clinical Research Organization, MSc Statistics, Careers, Graduates

Is Multiple Imputation in Clinical Trials Worth the Effort?

Statistical Consultancy Team

In a case study examined to look at Multiple Imputation (MI) in clinical trials, comparing Active to Placebo treatment (at Weeks 2, 4, 6 and 12 of the trial) in adolescents with acne, drop outs were common.  The primary endpoint was the number of lesions at Week 12.  The factors believed to affect the propensity to be missing included age, side effects and lack of efficacy, and thus missing data patterns differ between groups. 

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Topics: Statistical Programming, FDA, SAS Programming, Statisticians in the Pharmaceutical Industry (PSI), Propensity Scoring, Multiple Imputation

Prentice-Wilcoxon Test for Paired Time-to-Event Data

Statistical Consultancy Team
In survival analyses we conventionally compare a time-to-event endpoint between two or more strata; patients are either represented in one strata or the other and the strata are independent of each other.
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Topics: Survival Analysis, Statistical Programming, Statisticians in the Pharmaceutical Industry (PSI), SAS Macros, Prentice Wilcoxon Test

An Introduction to Industry Training Course Review - Statisticians in the Pharmaceutical Industry

Statistical Consultancy Team

A Member of Quanticate’s Statistical Consultancy Team writes about their experiences whilst attending the course entitled “PSI Introduction to Industry Training Course”.

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Topics: Statistical Programming, Pre-Clinical Study, Biostatistics Consulting, Statisticians in the Pharmaceutical Industry (PSI)

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