Global Head of Biostatistics

vor 1 Tag

Baar, Schweiz Hobson Prior Vollzeit

Hobson Prior are looking for a Global Head of Biostatistics to join a fantastic biotech organisation on a permanent basis located in Baar. Our client is focused on triumphing distressing neurological illnesses.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- For this role, you will be responsible for general quality and precision of the deliverables of the evidence generation team.
- Offer wider training and leadership to guarantee that the biosimilars evidence generation missions and objectives are accomplished.
- You will strive to increase the scientific agility by enabling the execution of novel approaches and increasing operational effectiveness.
- Guide a team of statisticians, statistical programmers and clinical data managers of at least 5 - 7 people strong with biosimilars evidence generation.
- Form and uphold solid relationships within the biosimilars R&D and innovator R&D teams.
- Contribute to and/or guide cross-functional initiative serving as a representative of evidence generation and contribute to crucial biosimilars R&D governance meetings.
- Any other assigned duties.

**Requirements**:

- Educated to a PhD level in a biostatistics/statistics or similar discipline with at least 9-10 years of work experience or educated to a masters degree level in a biostatistics/statistics discipline with at least 11-12 years of work experience.
- Familiarity with regulatory interactions such as with the FDA, EMA, and PMDA and BLA/NDA/MAA proposals.
- Know-how of regulatory guidelines such as ICH E3, ICH E8, ICH E9 (R1), ICH E10.
- Comprehension of statistical principles and clinical trial strategies such as estimands, missing data, blinded sample size-reassessment, non-randomized trials, bio-equivalence trials.
- Capable of developing novel/creative statistical/technical solutions to multifaceted issues.
- Know-how of the development of clinical development plans such as Biomarker, PK, PK/ PD and efficacy/ safety studies.
- Programming knowledge such as SAS and/or R.
- CDISC standards know-how, for example: SDTM, ADaM and define.xml.
- Communication skills both verbally and in writing.
- Able to explain methodology and consequences of decisions in lay terms.
- Leadership abilities within an active strategy environment, priority assessments, adapting to changes, conflicts resolutions, and effective collaboration.
- People management skills with demonstrated ability in personnel development.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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