Director, Biostatistician job in Paramus
|Employer:|| Glenmark Pharmaceuticals Inc., USA|
|Category:||Research and Development|
|State:||New Jersey (NJ)|
Position Summary :
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.
- Provides guidance and statistical support to clinical research (review protocols, analysis plans, and clinical study reports).
- 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.
- PhD in mathematical/statistical science
- 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.
- 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