Director Biostatistics - Global Biopharma (remote) job in Frankfurt, Germany

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First Name*

Last Name*

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Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Statistics

Location: Germany

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a Director Biostatistics - Global Biopharma to join a biotech organisation. This role is on a permanent basis and is located in Frankfurt with the ability to work remotely from home.

Responsibilities:

Monitor outsourced statistical CRO actions and deliverables guaranteeing highest quality.
You will develop, execute and improve statistical procedures and standards.
Assist with and contribute to the development of divisional methods.
Engage with international regulatory authorities.
Offer statistical contributions to clinical development plans, clinical study protocols, clinical study reports, regulatory proposal documents, and publications guaranteeing precise deliverables.
Serve as a representative for statistics in cross-functional project and study teams within various projects.
Conduct sample size calculations and statistical analysis, as well as develop statistical analysis plans and guide TLF development.
The ideal candidate will validate analysis outcomes.

Key Skills and Requirements:

Educated to an advanced degree level in a statistics or biostatistics field.
Demonstrable experience working within a pharmaceutical organisation and/or CRO involving proposal involvement.
Know-how of clinical stud designs, statistical strategies adaptive designs, regulatory guidelines such as ICH, FDA, EMA, and statistical software such as SAS, EAST, and R.
Conscious of the bigger picture with a focus on quality, novelty and the ability to resolve issues.
Ideally possess prior involvement in clinical study designs within cell gene therapies such as CAR-T, iNEST, etc.

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan on h.hennigan@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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