Statistician Within Biosimilars Evidence Generation
vor 13 Stunden
Company Description
**Job Description**:
**Overview**
A randomized controlled trial (RCTs) allows estimation of the treatment effect of an intervention compared to a control in the study population, unconfounded by treatment assignment.
Intercurrent events are defined in the ICH E9 (R1) guideline as events that occur after treatment initiation and potentially affect the interpretation or the existence of the measurements. Depending on the trial objective and clinical question of interest, the intercurrent events occurrence leads to difficulty in numerical estimation and interpretation of treatment effects for a certain claimed therapeutic indication. For a long time, the “intention-to-treat” and “per protocol” treatment effects have been the norm in drug development and regulatory evaluation. There is available literature addressing the advantages, pitfalls and reasoning for aiming to estimate these treatment effects. Also, more recent research addresses the fact that they are not the only treatment effects of interest, especially after the development of the E9 (R1) estimands Addendum.
A clinical question of interest could arise regarding the treatment effect in so-called “stratum/strata” of patients, which may or may not experience an intercurrent event of interest. Analyses comparing the patients without the intercurrent events for intervention and control will not estimate a causal effect.
One of the strategies to handle intercurrent events, suggested by the ICH E9 (R1) addendum is the **principal stratum strategy**. When this strategy is used to handle an intercurrent event of interest, the target population can be the principal stratum of patients in which the intercurrent event would occur. It can also be the principal stratum of patients in which the intercurrent event would not occur. The clinical question of interest relates to the targeted treatment effect in a principal stratum.
In rheumatoid arthritis disease setting and in other treatments with biologicals, such as with monoclonal antibodies, one intercurrent event of interest is the development of ADA. When this occurs in patients, treatment changes are made. Consequently, this may not allow further treatment administration in some patients, but it would be of interest to know the treatment effect among the patients who would not develop ADA.
**The objectives of this project are**:
- To formulate a meaningful clinical objective related to the stratum of patients that would/not experience the intercurrent event of interest “development of anti-drug antibody (ADA)”.
- To construct the corresponding estimand that is aligned with this objective and formulate possible sensitivity analyses.
- To estimate the estimand (which leads subsequently to unwanted treatment changes).
- **_ Project outline: _**_ADAs for biological therapies in the indication rheumatoid arthritis (RA)_
- **_ Scientific question: _**_What is the treatment effect in the principal stratum of patients who would/not develop ADA?_
- **_ Disease setting and database: _**_RCT conducted in RA_
- **_ Primary outcome: _**_ACR20_
- **_ Intercurrent event: _**_Development of ADAs_
- **_ Stratum of interest: _**_Patients who would develop ADA._
This kind of scientific question (about a stratum of patients experiencing an intercurrent event of interest) is often not related to the primary objective of the trial, but it is an important follow-up question for patients and prescribers to characterize the treatment effects in such across strata defined by intercurrent events (e.g., development of ADAs).
The result of this analysis can add to the pool of evidence that a trial can generate and may have deep implications on how a medicinal product is used in clinical practice (prescribers, physicians and patients) and even in labelling. Furthermore, it is a clinical question of interest for the patients who may pose the question “How much can I benefit from the treatment if I were to develop ADA?”.
You would be expected to work on the following tasks:
- Collaborate with colleagues from clinical and biostatistics departments to formulate clinical question of interest, and to construct corresponding estimand and sensitivity analyses.
- Write a statistical analysis plan for the re-analysis of the RCT in order to estimate the estimand.
- Conduct analyses (R/ SAS).
- Report results.
- Write and submit abstract for poster and/or oral presentation at a relevant conference (PSI, EFSPI and/or ISCB).
- Present results to cross-functional team of BIOGEN.
- Write report summarizing the proposed methodology and findings.
- Generation of a publication with the help of the BIOGEN team (including medical writing support).
**Qualifications**:
- A good command of English is required.
Additional Information
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work
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Baar, Schweiz Biogen VollzeitCompany Description Job Description** Overview** A randomized controlled trial (RCTs) allows estimation of the treatment effect of an intervention compared to a control in the study population, unconfounded by treatment assignment. Intercurrent events are defined in the ICH E9 (R1) guideline as events that occur after treatment initiation and potentially...
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Baar, Schweiz Biogen VollzeitCompany Description Job Description** Overview** A randomized controlled trial (RCTs) allows estimation of the treatment effect of an intervention compared to a control in the study population, unconfounded by treatment assignment. Intercurrent events are defined in the ICH E9 (R1) guideline as events that occur after treatment initiation and potentially...
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