Job Title: Head of Biostatistical Programming & Data
Applications
Company: German, global pharma
Location: Germany
Remuneration: Industry leading package + International relocation
Our client is an independent and research-based pharmaceutical company with
international operations. They intend to continue to be a major competitive
force in the future, quickly bringing to market those innovative products
which are currently filling its research and development pipeline.
As the first step along this path, they have invested heavily in the
expansion of its core expertise in analgesics, gynaecological preparations
and novel drug delivery systems in the last few years and are doubling their
Research and Development budget over the next three years.
Our Client is now seeking ambitious and talented people to take on the role
of Head of Biostatistical Programming & Data Applications
Primary Purpose of Position
- Develop and maintain a standardized data depository to support regulatory
submissions, Biostatistical analyses, PK/PD modeling, trial simulations,
safety monitoring and ad hoc queries
- Ensure utilization of up-to-date, efficient and cost-effective
biostatistical programming and data applications practices in compliance
with regulatory expectations, client SOPs and client working procedures
- Allocate 60% to project billable activities by taking over the Lead
Biostatistical Programmer responsibility and the biostatistical programming
tasks for the most highly prioritized client project(s)
- Provide input in the clinical project and study teams regarding
biostatistical programming activities and data applications as needed
- Collaborate with IT to ensure optimal selection, maintenance and
validation of hardware and software to meet Competence Centre requirements
Management Roles & Responsibilities
- Ensure efficient utilization of internal and external
Biostatistical Programming and Data Applications resources to meet
requirements of Biostatistics and Modeling & Simulation departments in a
timely, cost-effective and quality-conscious manner
- Provide leadership, promote communication and adequate information flow to
motivate, encourage and align people with the company's strategic objectives
- Coordinate and manage processes and interfaces with other organizational
units and relevant external partners
- Identify training requirements and ensure adequate training of employees
in compliance with current professional requirements of the position, SOPs
and regulatory guidelines
What we are looking for:
Long-lasting experience in SAS programming
Biostatistical programming
Data management
Project management experience
Basic understanding of regulatory processes and formats involving
pharmaceutical data
Basic understanding of S/W development
Medical database development experience
Basic understanding of Systems & S/W Validation (CFR 21 11).
From a personality perspective you will be:
A driver
Results-driven
Flexible
Team- player
Service-oriented person
Global sense/awareness
This is a genuinely exciting and challenging role, in a future-oriented
environment.
The successful candidates will have a real chance of personal and
professional advancement and growth.
If you are looking for a position where you can move forward your career in
a global and dynamic company then contact us to have a confidential
conversation.
Ash Butt LL.B Law (Hons) | Managing Director | AspirionPharma
Direct Line + 44 (0) 208 304 6538
Fax + 44 (0) 208 304 6549
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www.aspirionpharma.com
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