Global Head of Biostatistics

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View: 166

Update day: 10-04-2024

Location: Baar Zug ZG

Category: Sales

Industry: Staffing Recruiting

Position: Director

Job type: Full-time

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Job content

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.
  • Partake in the due diligence assessment of biosimilars candidates.
  • 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.
If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at +44 203 854 1033.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
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Deadline: 25-05-2024

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