Principal Statistician

Purpose

The role of the Principal Statistician is to provide statistical support to the statistics and programming department across a range of projects, clients and therapeutic areas. The Principal Statistician may also perform a supervisory role (e.g. line management and/or project management).

Key Responsibilities

Development of Methods Table:

The candidate will lead the effort to develop and refine versions of the methods table, which will list methodologies required for clinical trial reporting and align those methods to existing R packages or identify gaps to be filled.

Collaboration with various SMEs and regular reviews with experts will be essential.

Package Review: -

The candidate should be capable of conducting package reviews from a statistical methods perspective - While the candidate may not be an expert in all areas, they must proactively engage relevant experts when needed -

Responsibilities include (as required) reviewing journal publications, conducting simulations (if required), and assessing whether the methods applied in the package align with the latest capabilities or improve upon current state-of-the-art tools.

Prioritization of Package Evaluation:

The candidate will help prioritize package evaluations, which may involve liaising with respective PS or SLS teams. They will recommend project teams based on

available alternatives in the methods table, which will involve interaction with SMEs and package development teams.

Strategic Communications:

This individual will partner with client on communications at the Stats VP level, highlighting progress, focus areas, and key updates.

Desired Capabilities:

Strong statistical methods expertise with the ability to quickly learn and apply new methodologies. Solid knowledge of clinical study reporting, including inferential and modeling perspectives. Proficiency in R, with practical experience using diverse R packages. Working knowledge of SAS, ideally with an understanding of how Stats PROC aligns with statistical methods to help identify corresponding R packages.

Technical:

• Perform technical review and provide input into clinical trial documents including protocols, CRFs, CSRs
• Author and review study SAP, TFL shells and dataset specifications
• Support study and/or compound level activities advising on study design and statistical issues across phases and therapeutic areas
• Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice
• Application of complex statistical techniques (e.g. mixed effects, non-linear modelling, Bayesian, advanced survival), model checking and interpretation
• Identify and implement appropriate sample size method using software or simulations
• Identify data and standards issues and resolve or escalate as appropriate
• Awareness of emerging standards and associated impact to ongoing and future planned trials
• Maintain proficiency in statistical methodology
• Maintain study master file documents and any other documents that are required to be audit ready

People Management:

• Line management of statisticians, programmers and other technical staff. Accountable for overall performance of direct reports
• Provide coaching and mentoring of staff to achieve excellence. Direct employee career development and ensure line reports receive appropriate training to perform their day-to-day jobs
• Interview and effectively on-board and integrate new staff members
• Provide statistical technical leadership and coaching

Project Management:

Oversight of key client projects/portfolios. To include:

• Being Veramed Project Manager on client accounts and projects
• Maintain the project plan o Proactive management of resource, scope change and risks
• Manage the delivery of projects to budget
• Manage client expectations and issue resolution .

General:

• Lead internal and client study, project and cross functional team meetings effectively
• Present study updates internally and at client meetings
• Share scientific, technical and practical knowledge within the team and with colleagues
• Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
• Build effective collaborative working relationships with internal and client team members
• Ensure learnings are shared across projects or studies
• Develop and provide internal technical training where appropriate
• Lead process improvement initiatives

Minimum Qualification Requirements

• MSc or PhD in Statistics/Biostatistics (or equivalent)
• At least 7 years of relevant industry experience Other Information/Additional Requirements
• Understanding of clinical drug development process, relevant disease areas, endpoints and different study designs
• Awareness of industry and project standards & ICH guidelines
• Excellent verbal and written communication skills
• Interpersonal/teamwork skills for effective interactions
• Proficiency in data handling using SAS or other statistical software (e.g. R)
• Self-management skills with a focus on results for timely and accurate completion of competing deliverables
• Demonstrated problem solving ability and attention to detail
• Ability to work independently and as part of a team
• Ability to manage a portfolio of projects and/or people

Specific Key Responsibilities: