Associate Director Biostatistics - REMOTE job in Mainz (55131), Germany

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?*

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?*

Message

Job type: Permanent

Discipline: Statistics, Informatics, Programming

Location: Germany

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

Associate Director Biostatistics - Permanent - Remote

Proclinical are recruiting for an Associate Director Biostatistics to join a global biotech company. This role is on a permanent basis with the ability to work remotely from anywhere in the UK.

Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.

Responsibilities:

Represent statistics in cross-functional project and study teams in multiple projects
Provide statistical input into Clinical Development Plans, Clinical Study Protocols, Clinical Study Reports, regulatory submission documents, and publications ensuring accurate deliverables
Perform sample size calculations, develop statistical analysis plans and lead TLF development
Perform statistical analyses and validate analysis results
Oversee outsourced statistical CRO activities and deliverables ensuring highest quality
Develop, implement and improve statistical processes and standards
Support and participate in the development of departmental strategies
Interact with global regulatory authorities

Key Skills and Requirements:

PhD or Masters in statistics or biostatistics
Five years (Master) and three years (PhD) experience in the pharmaceutical industry and/or CRO including submission experience
Excellent knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH, FDA, EMA) and statistical software like SAS, EAST, and R
Awareness of the bigger picture, strong orientation to quality, innovative and solution orientated thinking
Preferred experience with clinical study designs in oncology or infectious diseases

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at 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.

#Biometrics