Biostatistician Technical Expert - Clinical Statistics

Main Responsibilities

• Support the clinical development plan (CDP), clinical study design (including protocol development and review), the study setup and conduct.
• Conduct / Oversee the execution of the statistical analyses according to the SAP and ISAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.
• Serve as a biostatistical consultant for other members of the department and staff members from other statistics department within the organization. Provide mentoring and coaching advanced statistical methodologies to junior statisticians in Hub.
• Maintain knowledge and awareness of development in biostatistics and clinical trial methodology and regulatory requirements that impact on analysis.
• Accountable for all assigned statistical deliverables related to multiple studies or specific domains: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, Estimands etc., SAP, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables).
• Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives. Contribute to define and review the specific deliverables related to Transparency and Disclosure.
• Coordinate with study programmer the production and Qc of statistical analyses.
• Contribute to operation process optimization and provide inputs to statistics and quality standards.
• Represent statistics team to participate in scientific or technology working groups or cross function initiatives.
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Experience

(MS) or (PhD) of solid pharmaceutical industry experiences.

Experience Of Project Management And Development Preferred.

Soft and technical skills:

Broad knowledge and good understanding of advanced statistical concepts and techniques

Demonstrated strong project/study management, interpersonal and communication skills.

Good knowledge of pharmaceutical clinical development, together with early, late phase and post-marketing experiences

Extensive ability to apply advanced statistical analyses using SAS and R languages.

Knowledge or experience with Artificial intelligence or Generative AI is a plus

Education: MS or PhD degree in Statistics or relevant fields

Languages: Highly effective communication in English, both oral and written.null

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