Leading and managing team of internal and external biostatistics and statistical programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development.Managing assignments and priorities of team members; Ensuring accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents; Coordinating achievement of major statistical deliverables and milestones in collaboration with other functions; Leveraging standardization to maximize global data integration and interpretability; Providing statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions and follow up; Providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
Requirements:
A PhD in Statistics/Biostatistics and at least 7 years of relevant pharmaceutical experience or a MSc in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience; Comprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modeling and adaptive design; regulatory requirements relating to clinical development of drugs and biologics; BLA/NDA experience including eCTD submissions; Working knowledge of major statistical software programs including SAS; Knowledge of CDISC requirements for SDTM and ADaM
Text:
Associate Director, Biostatistics Leading and managing team of internal and external biostatistics and statistical programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development.Managing assignments and priorities of team members; Ensuring accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents; Coordinating achievement of major statistical deliverables and milestones in collaboration with other functions; Leveraging standardization to maximize global data integration and interpretability; Providing statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions and follow up; Providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies A PhD in Statistics/Biostatistics and at least 7 years of relevant pharmaceutical experience or a MSc in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience; Comprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modeling and adaptive design; regulatory requirements relating to clinical development of drugs and biologics; BLA/NDA experience including eCTD submissions; Working knowledge of major statistical software programs including SAS; Knowledge of CDISC requirements for SDTM and ADaM
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