- Excellent employment opportunity for a Sr. Statistician in the Gaithersburg, MD area.
- TA Statistics is the group that oversees and delivers all the statistical and programming contribution to design, decision-making, interpretations and communication internally and externally for the TA portfolio of projects and is engaged in shaping the TA external environment.
- Candidate Focus & Challenge –Provides statistical expertise to support the design and interpretation of clinical programmes, regulatory submissions and commercialization.
- Analyses internal and external information to inform design decisions and the development of decision criteria.
- Provides support to the regulatory submissions including specification of overview documents and response to regulatory questions.
- Identifies opportunities for the application of modelling and simulation to improve study design.
- Identifies opportunities to improve the methodology and provide practical solutions for problems.
- Identifies and applies statistical methodology to improve the process and delivery activities.
- Contributes to the development of best practice to improve quality, efficiency and effectiveness.
- To be considered for this Sr. Statistician job opportunity you must have a MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) preferably with experience in pharma/healthcare or other relevant areas.
- Minimum of 5 years of relevant experience is required.
- Knowledge of the technical and regulatory requirements related to the role.
- Experience of Development, programme design and data analysis and interpretation.
- Must have experience of regulatory, commercial or early development support work required.
- Excellent Communication skills required.
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