Global Head of Biostatistics

vor 4 Monaten

Baar, Schweiz Proclinical Vollzeit

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 cross-functional 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 9-10 years of pertinent work experience or educated to a Masters degree level in a biostatistics/statistics or similar field with at least 11-12 years of pertinent work experience.
- Previous involvement in regulatory tasks which involves engaging with FDA, EMA, and PMDA and BLA/NDA/MAA proposals.
- Know-how 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 size-reassessment, non-randomized trials, bio-equivalance 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.
- Know-how of programming in SAS and/or R.
- Knowledge of CDISC standards, for example: SDTM, ADaM and define.xml
- 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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