Senior Statistician II

AstraZeneca; Durham (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

AstraZeneca in Durham, NC seeks a Senior Statistician II to lead design, analysis and interpretation for preclinical and clinical programs, with mentoring of junior staff. You will develop SAPs, support regulatory submissions and contribute to decision making.

This role emphasizes cross-functional collaboration, meticulous statistical work, and applying innovative methods in a fast-paced pharma environment with on-site and flexible office days.

Qualifications

• Master's degree with 4+ years in Statistics or related field.
• PhD with 2+ years in Statistics or related field.
• Experience in pharmaceutical industry is desirable.

Responsibilities

• Provide statistical expertise for complex design and interpretation for preclinical or clinical programmes and regulatory submissions.
• Analyse information, perform modelling to inform design decisions and development of decision criteria.
• Develop Statistical Analysis Plans for complex studies.
• Coach/guide less experienced statisticians in analyses, graphics and tables for reports/publications.
• Communicate results of complex studies and contribute to regulatory submissions.

Skills

Statistical expertise

Communication

Team collaboration

Education

Master's degree + 4 years

PhD + 2 years

Tools

SAS

R

Job description

Senior Statistician II has sufficient experience working as a statistician in the pharmaceutical industry to be working independently on activities relating to design, delivery and interpretation, preclinical studies, regulatory submissions and/or commercialisation. This individual is able to perform and communicate results of more technical analyses, and able to guide less experienced staff. They have the scope to develop creative statistical ideas and approaches, and to apply them in their work. Competent individual contributor with excellent cross-functional collaboration.

The Senior Statistician II may work directly within a project and/or support statistical methodological advances.

The accountabilities for supporting projects directly are:

• Provide statistical expertise for complex design and interpretation for preclinical or clinical programmes, high level internal governance committees, regulatory submissions and/or commercialisation
• Analyse internal and external information, perform modelling and simulation to inform design decisions and the development of decision criteria
• Develop a Statistical Analysis plan for complex studies and/or project deliveries
• Act as a coach/guide for less experienced statisticians in the production of analysis, supporting graphics and analysis tables for study reports, Global Medical Affairs studies or publications
• Able to analyse, interpret, summarise and communicate results of complex studies
• Contribute to the regulatory submissions including specification of overview documents and response to regulatory questions
• Identify opportunities for the application of modelling and simulation to improve study design
• Identify opportunities to improve the methodology and provide practical solutions for problems
• Identify and apply statistical methodology to improve the process and delivery activities
• Contribute to the development of best practice to improve quality, efficiency and effectiveness
• Accountable for the quality of their statistical work; provide discipline-specific understanding, insight and constructive challenge and take ownership of development needs, seek coaching or training opportunities

The accountabilities for supporting statistical methodological advances are:

• Under guidance of a more experienced statistician, produces pragmatic solutions, often within a tight time scale where the emphasis is to deliver first, then refine and develop solutions thereafter.
• Draft statistical analysis plans for complex studies
• Provide consultancy within area of expertise to fellow statisticians working within therapeutically aligned statistics groups, as well as medical scientists and other key roles across the business
• Investigate and apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration
• Investigate and improve statistical approaches, establish standards and best practice, develop and implement new methodology interacting with external scientists
• Identify new areas where we can add value, developing collaborative relationships with the external scientific/academic community and maintaining academic links
• Contribute to/or lead the development of a process improvement and/or capability area within the Department
• Develop a strong understanding of the pharma business/AZ ways of working
• Communicate research and results internally and externally through participation at conferences and journal publications.

Key relationships to reach solutions

• All levels of functions within Biometrics
• Therapeutic Area scientists
• Collaboration partners in other departments
• Drug project leading roles in GPT and CPT
• Vendor counterparts as well as Project Managers and other Biometrics contacts

Education, Qualifications, Skills and Experience

• Master's degree + 4 years of Experience or PhD + 2 years of experience in Statistics, Mathematics (containing a substantial statistical component), or recognised equivalent to stats MSc

Desirable

• Competent statistical programmer (SAS and R)
• Knowledge of key technical and regulatory requirements
• Experience of design, analysis and reporting of preclinical or clinical studies in more than one setting
• Communication skills
• Experience and knowledge of statistical methods and applications in study design, analysis and interpretation
• Collaboration required
• Ability to apply statistical expertise to problems, problem solving and quality focus

When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and ambitious world!

Why AstraZeneca

Here, curiosity powers progress-teams are encouraged to follow the scie