Associate Director, Statistical Science - Biostatistics

Location: Gaithersburg

Associate Director,Statistical Science has experience working as a statistician in the pharmaceutical industry to independently lead statistical work within a project, an indication within a more complex project or complex studies. You will work in the Biometrics team either in- house or partnering with CROs to ensure delivery to quality and time.

You Will:

• For a project or indication in clinical therapeutic areas

• Lead the delivery and oversight on a multiple studies/indication within a project, potentially as a Global Project Statistician for a standard drug project.

• Lead the statistical thinking and contributions to the delivery of studies, development plans, regulatory strategy, health technology assessment and/or commercial activities

• Direct project work, including statistical staff and/or CRO partners, to ensure delivery to standards, quality and time

• Develop design options and provide high-quality decision support to allow the business to make informed decisions about a study or project

• Measure the benefit, risk, value and uncertainty of the latest asset/product profile

• Investigate and apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration, including modelling and simulation

• Coach and support the training of statistics staff

You Have:

• MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognised equivalent to stats MSc

• 5+ yrs of experience of pharmaceutical development, data analysis and interpretation and experience of program design.

• Knowledge of programming in R and/or SAS

• Knowledge of the technical and regulatory requirements related to the role

• Excellent collaboration skills to work across functional boundaries

• Apply statistical expertise to complex problems focusing on quality.

Desirable:

• Project Management Skills

• Proficiency in SAS and R/Python languages