• Single point accountabilities and decision-making for your individual role should be agreed with your manager and captured in your MyPlan and Workday.
Technical Expertise, Scientific Leadership and Strategy:
• Acts as an internal expert for some methodologies.
• Develops and applies knowledge and understanding of emerging statistical methodologies/new research.
• Utilizes sources of data and information (internal/external) and applies statistical concepts to explore and recommend optimal designs.
• Influences statistical strategy through authoring analysis plans, sections of key documents (e.g. protocols) and presentation materials.
• Performs appropriate analysis and interpretation and uses a wide range of statistical approaches and/or applicable software to explore options.
• Supports engagement with regulatory agencies on key statistical issues and approaches (under supervision).
• Shares learnings with peers and contributes to internal technical discussions/forums.
• Effectively explains technical concepts to non-statisticians.
• Contributes to department strategies and key initiatives through working groups and sub teams.
Innovation, Problem Solving and Decision Making:
• Anticipates problems within discipline, proactively uses own expertise and/or seeks input from others, to recommend solutions and influence appropriate change.
• Proactively identifies areas where novel strategies can be applied and effectively communicates rationale.
• Uses technical expertise in matrix-discussions to support evidence-based decision making.
• Contributes to a working group to explore an innovation or business strategy.
Compliance, Quality and Governance:
• Thorough knowledge of all GxP, ICH requirements, internal processes and external regulations that govern drug development (where applicable).
• Ensures archiving commitments related to own tasks are handled proactively and facilitates issue resolution.
• Contributes to after action reviews and the development of solutions.
• Understands how Client policies and procedures impact projects and is fully compliant in implementation.
• Contributes to the development or improvement of departmental policies and working practices.
• Develops responses to audit/inspection questions and complete CAPAs within agreed timelines.
• Performs and documents oversight of outsourced activities including Quality Assurance (QA)
• Identifies and addresses issues at study/project level and works to develop solutions with internal teams and/or outsourced partners.
Communication and Influence:
• Independently, prepares detailed oral or written summaries in the context of strategic fit, feasibility, and rationale for projects appropriate to audience.
• Effectively presents at internal forums and external professional industry meetings.
• Effectively communicates technical and complex approaches to peers and non-technical colleagues demonstrating influence and successful outcomes.
• Demonstrates effective communication to all stakeholders on project deliverables.
Collaboration and Matrix-Working:
• Works effectively and proactively in multi-disciplinary teams and a matrix environment through effective listening and active participation in challenging discussions
• Demonstrates networking skills through interactions across departments and divisions.
• Begins to develop networking skills with external partners and key opinion leaders/experts.
• Effectively contributes to internal and external collaborations.
• Demonstrates appropriate engagement with outsourced partners.
Leadership and People Development:
• Self-awareness of development needs and proactively identifies opportunities to support development objectives.
• Able to understand and clarify boundaries of responsibility within own role; allocates decision making authority and task responsibility to others as appropriate.
• Acts as a mentor or coach for current staff members.
• Involved with recruitment activities.
• May start to develop First Line Leader (FLL) capabilities.
Basic Education (indicative of entry level, not mandated for career progression):
• Has theoretical and practical knowledge typical of at least MSc in Statistics and/or a combination of education and experience.