In this role, the candidate will ensure comprehensive and optimized statistical input from early development to submission. He/She will provide a “state-of-the-art” Statistical methodology and compliance with worldwide guidelines.
Key Responsibilities:
Promote statistical expertise to optimize R&D activities.
Implement state-of-the-art and innovative trial designs, statistical models, and analysis methodologies.
Provide strategic input to development programs including study design, analytic methods, endpoints that meet both regulatory and scientific requirements.
Ensure that technical reviews of all statistical deliverables are performed appropriately and accurately before being released.
Act as leader for all biostatistical deliverables for a clinical development project.
Provide statistical direction and technical oversight for complex projects requiring statistical input.
Set the strategic direction for addressing statistical issues in regulatory submissions, and directly influence drug development decisions with internal and external partners.
Ensure an effective, high quality and timely response for regulatory activities, especially in relation to regulatory submissions and questions.
Increase the operational efficiency of the biostatistics group by assisting in developing policies, procedures and strategies for Biostatistics and be an active actor in the quality improvement processes.
Ensure contracts and relationships with CROs for Statistical activities are managed in an efficient, high quality and timely fashion.
Set up collaborations with scientific experts.
Assumes other duties and responsibilities as assigned.
Education:
PhD in mathematical/statistical science
Experience:
Minimum 10 years of relevant industry experience in the statistical analysis of biomedical data.
Good knowledge of early phase activities – to Proof of Concept.
Strong experience in the field of statistics in relation to one of the following TA: Oncology, Immunology/dermatology or Respiratory.
Strong experience with submissions and regulatory meetings, BLA/NDA experience required.
Skills:
Able to manage many projects simultaneously with the ability to prioritize.
Able to explain methodology and consequences of decisions in lay terms.
Able to understand requests for complex analyses.
Excellent leadership and verbal/written communication skills.
Excellent knowledge of statistical software (e.g. SAS, S+, R, ….)
Ability to develop innovative/creative statistical/technical solutions to complex problems.
Experienced in working in a multicultural working environment
Good understanding of clinical development and regulatory approval process (FDA).
Strong technical statistics knowledge – recognized as such through publications, industry meetings etc.
Ability to drive change and influence decision making.
Ability to use competitive intelligence to influence clinical development.
Good experience in managing CROs
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