Innovative, Research-Focused German Pharma Company requires
Biostatistical Expert (BE)
We have been retained to search by our client for market leading
individuals to take on the role of Biostatistical Expert (BE).
Our client is one of the most innovative and exciting pharmaceutical
companies operating in the global pharmaceutical market today,
headquartered at the heart of Europe.
They have initiated a process of expansion and re-organisation which
will enhance their capability to ensure the highest quality standards
across all sectors of their operation.
Primary Purpose of Position
The main responsibilities of the Biostatistical Expert include:
* Provide statistical input at the clinical project and study
level and provide trial-related calculations in
* alignment with the overall clinical strategy
* Plan, analyze and report the biostatistical part of a clinical
project and / or study, including the introduction
* and implementation of biostatistical methods
* Provide input to the clinical part of regulatory documents
* Represent the statistical aspects of a project at regulatory
authorities and in the scientific community
* Cooperate with Clinical Research Organizations
* Recommend resource needs and analysis costs for trials
* Work according to ICH-GCP and ICH-biostatistics guidelines
* Instruct and supervise SAS-Programmers
* The Biostatistical Expert contributes to other activities of the
Clinical Core Team and Study Team as defined in the respective team
profiles.
Functional Roles & Responsibilities:
* The following description documents specific process-related
tasks for which the Biostatistical Expert is accountable and / or
responsible.
In the process "Analyze clinical project results across studies" the BE
is:
* Accountable and Responsible: Prepare and finalize the
Statistical Analysis Plan (SAP)
* Accountable and Responsible: Prepare statistical analysis /
generate tables for report
In the process "Communication of top-line results" the BE is:
* Accountable and Responsible: Generate tables and analysis for
top-line data (TLD)
* Responsible: Communicate and discuss data with ICPL / CE / CP
In the process "Plan and prepare study" the BE is:
* Accountable and Responsible: Develop and maintain the
Statistical Analysis Plan
* In the process "Order and supply study medication" (6.2.4) the
BE is
* Accountable and Responsible: Prepare the random list
* In the process "Develop final SAP" (6.2.6) the BE is
* Accountable and Responsible: Develop and review draft SAP and
implement changes, if necessary
* Accountable and Responsible: Prepare and review mock analysis
and implement changes, if necessary
Functional Roles & Responsibilities
* Accountable and Responsible: Prepare prefinal draft of SAP and
implement changes, if necessary
* Accountable and Responsible: Distribute final SAP
* In the process "Conduct data management" (6.3.4) the BE is
* Accountable and Responsible: Perform blind data review
* In the process "Analyze and report study" (6.4.0) the BE is
* Accountable and Responsible: Conduct analysis
In the process "Conduct analysis" the BE is:
* Accountable and Responsible: Prepare and review listings for
population allocation and primary endpoint
* and implement changes if required
* Accountable: Describe population allocation in final SAP
* Accountable and Responsible: Review final SAP and implement
changes if necessary
* Accountable and Responsible: Distribute finalized SAP
* Accountable and Responsible: Perform statistical analysis /
generate tables for report
* Membership in Decision Bodies and Major Internal Working Groups
Chair Member Ext'd
* Clinical Core Team
* Study Team
Interfaces with Other Departments/Functions
* Science
* Operations
* Project Management
* Sourcing Management
* Regulatory
* Drug Safety
* Marketing
* Quality Assurance
Additional requirements
Education
* University degree in mathematics/statistics, biometry or
equivalent required
* Fluent business English, working knowledge of German beneficial
* Industry-specific knowledge
* Solid knowledge of biostatistical methods
* Strong practical experience in mathematics/statistics or
biometry required
* Knowledge of relevant guidelines
* Familiar with relevant aspects in clinical research and
regulatory processes
* Insight in medicine and drug safety in order to optimize design
of studies in co-operation with specialists
* from other disciplines beneficial
Additional requirements
Personal skills & abilities
* Organize work in a structured fashion with attention to detail
and compatible with other activities in the
* clinical project and / or study
* Strong communication skills
* Proven ability to work in a team setting
* International and intercultural work experience
* Knowledgeable about our clients key indications
(pain/analgesics/oncology)
* Key stakeholders in R&D functions, neighboring functions
* Particularly attractive characteristics include:
* Smart/intelligent
* Decision-maker
* Focused
* Quality conscience
* Technically sound
* Motivated
If you feel that this position could offer you a chance to develop your
career then feel free to forward me a copy of your CV in order to
facilitate a further confidential discussion.
AspirionPharma Ltd - Who are We?
AspirionPharma is a niche executive search firm specialising in the
provision of recruitment solutions to the global bio/Pharma and CRO
sectors.
Utilising a developed and tested methodology we are able to provide
delivery on projects that other firms simply cannot.
Furthermore, we are positioned to provide additional "value-added"
benefits to our clients by acting as their "agents in the field" and
providing relevant industry information. We also ensure that they are
kept up to date (and in contact) with UQIs and industry leaders; this is
done through a tried and tested system of "Talent management".
We aim to provide a consultative approach to both clients and candidates
and will only proceed if we are sure that a prospective move will not
only aid fulfilling our clients strategic aims, but its also matches and
exceeds the expectations of our candidates.
Targeting only real market leaders, we are well aware how crucial it is
to fully understand the true aspirations of each individual before
acting on their behalf. It is this commitment to quality, combined with
an information led approach and developed methodology that sets us apart
from the mainstream.
Whether you are an industry leading individual or a firm wishing to take
the next step in your development let AspirionPharma help you achieve
your aspirations.
www.aspirionpharma.com <http://www.aspirionpharma.com/>
Aspirion Pharma Ltd (London)
Part of FutureScope Holdings Ltd
Ash Butt LL.B Law (Hons) | Managing Director | AspirionPharma
Direct Line + 44 (0) 208 304 6538
Fax + 44 (0) 208 304 6549
Mobile + 44 (0) 7841 446 298
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