Global Head of Biostatistics - Baar, Schweiz - Proclinical

Proclinical

Geprüftes Unternehmen

Baar, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

Proclinical are recruiting a Global Head of Biostatistics for a pharmaceutical organisation. This role is on a permanent basis and is located in Baar.

Responsibilities:

Responsible for oversight of actions conducted by CROs/external partners.
Guide a team of biostatisticians, statistical programmers and clinical data managers in biosimilars evidence generation.
Serve as a representative for the company in statistical forums at conferences pr scientific meetings.
Offer wider training and direction to guarantee that the biosimilars evidence generation missions and objective are completed.
Form and uphold solid relationships with biosimilars R&D and innovator R&D teams.
You will serve as the main functional evaluation/approver of CRFs, protocols, analysis plans and clinical study reports.
Contribute to and/or guide crossfunctional initiatives representing evidence generation as well as crucial biosimilars R&D governance meetings.
Other duties may be assigned to this role.

Key Skills and Requirements:

Educated to a PhD degree level in a biostatistics/statistics or similar field with at least 910 years of pertinent work experience or educated to a Masters degree level in a biostatistics/statistics or similar field with at least 1112 years of pertinent work experience.
Previous involvement in regulatory tasks which involves engaging with FDA, EMA, and PMDA and BLA/NDA/MAA proposals.
Knowhow of pertinent regulations for regulatory actions such as ICH E3, ICH E8, ICH E9 (R1), ICH E10, etc.
Comprehension of statistical principals and clinical trial strategy such as estimands, missing data, blinded sample sizereassessment, nonrandomized trials, bioequivalance trials, etc.
Able to develop novel/creative statistical/technical solutions to multifaceted issues.
Expertise in the development of clinical development plans which involves Biomarker, PK, PK/ PD and efficacy/ safety studies.
Knowhow of programming in SAS and/or R.
Knowledge of CDISC standards, for example: SDTM, ADaM and
Communication skills both verbally and in writing.
Leadership capabilities with demonstrated success in personnel development.

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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