Senior Manager Statistician

작업 내용

Site Name: Marburg - Office, Belgium-Wavre
Posted Date: Jun 2 2021

Job Purpose

Work in a global team as statistical / data analytics expert for all aspects of statistics and data analytics within GIO and Quality organization during the lifecycle of assays, products and processes. Essential and accountable partner or member of project teams, management and key stakeholders in the organization in providing statistical support.

Actively collaborate with or lead multidisciplinary multicultural teams (task forces, investigations, improvement projects) to provide input to assessments by application of statistical and data analytics methodologies and appropriate interpretation.

Manage and influence internal and external global network in order to adopt rigorous and sound statistical approaches, globalize approaches. Assure alignment with internal and regulatory expectations.

Influence internal and regulatory guidelines. Influence external environment (e.g.regulators) by means of presenting at key conferences and publishing.

Your Responsibilities

In this role you,

• Act as essential partner for project teams or other stakeholder groups to provide expertise statistics support, guidance and consultation for all aspects of statistics for product, processes and analytical assays.
• Ensure high quality statistical evaluation and reporting, e.g. for regulatory dossiers which set a benchmark in the industry and result in high regulatory acceptance. Ensure integrity of statistical evaluation by ensuring application of appropriate statistical methodologies and traceability / reproducibility.
• Take full ownership and accountability of all statistical content. Typical applications include planning and evaluation of experiments (DoE), sample size calculation, process and method validation, assay or process trending, assay or process transfers. Lead global strategic projects requiring a statistical solution to fulfil regulatory requirements.
• Influence GSK internal policies, guidelines and SOPs to ensure appropriate statistical application. Represent the organization on key conferences and advocacy groups in order to influence the external and regulatory environment. Ensure compliance of data analyses with internal and external requirements (e.g. GSK QMS, GSK Vaccines VSOPs, Ph.Eur., ICH/FDA guideline).
• Support site implementation of GSK Vaccines requirements related to products and processes and monitor site implementation status.
• Monitor and assess new developments, industry trends, evolving regulatory expectations. Constantly standardize and refine statistics (e.g. specification setting) in order to assure application of state-of-the-art statistical and data analytics methodologies.
• Manage external and internal collaborations with statistical thought leaders and statistical groups in other functions and divisions. Represent GSK in internal and external boards. Influence external environment (e.g.regulators) by means of presenting at key conferences and publishing. Personal interaction and influencing of key regulators, FDA or other regulatory agencies, in the context of submission of dossiers, variations, etc.
• Actively cooperate with global statistical community of GSK to develop, align and standardize data evaluation methods, methodologies and conventions. This especially includes cooperation with statisticians within GQC&PQ, TRD and local statistical contacts. Manage and maintain relationship with GSK experts from other Business Units (e.g. Pharma) and outside GSK.
• Upskill the organisation on the application of statistics by statistical trainings for associates on the application of statistics and data evaluation tools. Ensure full integration of statistics across functions into everyday work as appropriate. Train and coach less experienced associates in the group and the organization. Ensure advanced statistical concepts are routinely being applied within global and local Quality and GIO organization.
• Focus on development of associates and building high performing team that has large positive impact on the organization. Help the GIO/Quality Statistics Manager in coaching and development of team members.
  

Why you?

Basic Qualifications

We are looking for professionals with the following required skills to achieve our goals (must-have):

• University degree in statistics, mathematics, data science, computer science or related field or comparable experiences
• 10 years of work experience in applying statistics and/or programming within industry/university, at least 5 years within pharmaceutical industry.
• Experience to work in cross-functional and cross-cultural teams.
• Strong expertise in applying statistics within pharmaceutical industry.
• Ability to select and apply adequate statistical models. Consequently, question model assumptions and technical conditions.
• Ability to derive clear and conclusive recommendations from statistical analyses
• and justify/explain applied statistical model.
• Broad knowledge of vaccines industry.
• Strong knowledge of relevant regulations and guidelines, e.g, stability guidelines (ICH, USP), relevant chapters from Eur.Ph.
• Long term experience and active exchange with Health Authorities such as FDA, EMA.
• Fluent in English (verbal and written). Second language desirable (e.g. French, German, Italian).
• Strong programming skills with at least one statistical programming language, preferable R, SAS, Python
• Ability to prepare suitable training content, facilitate efficient training session. Advise / train other statisticians to execute statistical trainings.
• Customer focused; ability to understand requirements of key stakeholders (GSK internal and external).
• Agile and proactive working style.
• Ability to deliver value early and frequently, e.g. by using short feedback cycles.
• Ability to adapt / accommodate / coordinate flexible work demands.
• Ability to manage networks and build relationships transversally across the GSK network and beyond.
• Ability of working in a multidisciplinary multicultural setting and across geographic boundaries.
  

Excellent communication and presentation skills

Preferred Qualifications

The following characteristics are assets (nice-to-have):

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

GSK Vaccines - Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com.

Our Department

Vaccines Global Qualityis responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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