Principal Statistician, Germany - P

Description:
Are you an experienced statistician looking for a company which can offer you real work-life balance? Are you interested in sharing your skills and expertise in a growing mid-sized CRO, where you can influence key decisions and truly make an impact? Do you currently have a role where you get the chance to improve departmental processes? CROMSOURCE is continuing to expand our Biometrics team at our offices in Aachen and we are looking for a Principal Statistician to help influence this growth.

We are looking for an experienced statistician to support our growing team of statisticians and programmers. You will work on varied therapeutic areas, be given the opportunity to work on a group of studies for a single client (leading to increasing responsibility and implementing efficiencies), providing analysis and expertise and as a key study team member you will have direct contact with our clients. There will also be opportunities to support the Management Team in organising and executing the departmental process initiatives and may also be the opportunity to act as the Project Lead Statistician on groups of customer studies. Additional, you may also have the opportunity to train and develop less experienced Statisticians and Programmers.

Main Job Tasks and Responsibilities

• Performs and leads the statistical analysis of a clinical study in compliance with the analysis plan and protocol
• Provide high quality statistical support direct to our clients whilst managing projects
• Provides statistical and methodological input for sample size calculation and protocol development
• Develops a detailed statistical analysis plan and related mock shells in order to pre-specify the statistical analysis according to the study protocol
• Performs or leads a quality control and senior review of the tables, listings, figures, datasets, inferential analysis and statistical text to ensure compliance with the protocol and SAP
• Leads Data Review Meetings, including coordination of preparations and production of meeting report
• Writes statistical reports and/or sections for the integrated study report, reviews the draft study report, and ensures that all data presented is correct
• Files all datasets, computer programs and other material used in the preparation of the tables, listings, figures, statistical analyses and statistical text for the integrated study report in order to have a complete and transparent documentation of the whole process
• When managing projects, understands project scope, efficiencies, milestones and budgets, ensures the project team understand project scope and minimize issues that impact on the project team, whilst ensuring tasks are appropriately delegated and completed according to CROMSOURCE SOPs
• Expert person, central reviewer of ADaM datasets, deliverables and processes, keeping abreast with all regulatory developments within CDISC
• Contribute to the development, implementation and maintenance of the quality system for Biometrics in general and biostatistics in specific, including process improvements and standards
• May assist in providing input into RFPs and bid defense meetings

Education & Experience:

• Advanced Degree in sciences, with substantial statistics component
• Significant experience as a statistician in life science/pharmaceutical/CRO environment
• Proven organizational and problem solving/decision making skills
• Expert knowledge of the applicable regulatory guidance
• Proficient in SAS software
• Proficient in Microsoft Office (e.g. Word, Excel, Outlook)
• Fluent in English and local language(s)
• Good communication skills
• Advantageous, project management and leadership skills

What CROMSOURCE can offer you:

• True work-life balance with flexible working hours
• Close management support to ensure workload is managed within a normal working week
• Opportunities for career progression/development, enabling you to progress within the department
• Variety within your work - our clients are small and mid-sized pharmaceutical, biotechnology and medical device companies; you can become truly embedded within the pharmaceutical aspect, including having direct contact with bodies such as the FDA and EMA
• The chance to work not only on clinical, IMP studies, but also medical device projects too

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002541

or please contact careers@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Statistician, Biostatistician, Senior Statistician, Senior Biostatistician, Principal Statistician, Statistical Analysis, Line Management, CRO, Medical Devices, Clinical Research Organisation, Aachen, Germany
Skills: Biostatistician, Principal Biostatistician, Senior Biostatistician, ADaM, Biostatistics, CDISC, Clinical Research Organisation, CRO, SAS, statistical analysis, Statistics Location: Germany Share:

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