Principal Statistician/Manager Statistics for Consultancy Team

Veramed; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Veramed is seeking an experienced Statistician to join its Statistical Consultancy Business Unit in the United States. The role focuses on providing statistical support across biotech and pharmaceutical projects, including study design, regulatory submissions, and client leadership.

The candidate should have a strong track record in consultancy and the ability to explain complex methods to non-statisticians.

Qualifications

• At least 10 years' experience in statistical consultancy or related roles.
• Ability to explain statistical concepts to non-statisticians.
• Ability to present to client teams and manage client expectations.
• Experience mentoring junior team members and delegating work.

Responsibilities

• Design studies including sample size calculations, simulations, and adaptive designs.
• Support statistical aspects of regulatory submissions and respond to regulatory queries.
• Provide project-level statistical input and oversee deliverables from other CROs.
• Develop/review study documentation including SAPs and protocols.

Skills

Statistical consulting

Client communication

Project management

Presentation to clients

SAS

R

Tools

SAS

R

Job description

An opportunity has arisen for a Statistician to join Veramed’s Statistical Consultancy Business Unit full time. The opportunity will be to provide statistical support to a variety of clients.

The Statistical Consultancy Business Unit typically works with small and growing Biotech and Pharmaceutical companies on a variety of projects across the full clinical development lifecycle. The areas in which we can provide statistical consultancy support include study planning and trial design, protocol development, regulatory statistical support, study conduct and oversight and other ad-hoc statistical support.

Responsibilities may include: study design, including sample size calculations, simulations and adaptive designs; support with the statistical aspects of regulatory submissions and responding to regulatory queries; project level statistical input; study statistical oversight; review and oversight of deliverables from other CROs; development and/or review of study documentation including the statistical aspects of protocols and statistical analysis plans; ad-hoc and exploratory analyses; other statistical support as required. The successful candidate would be expected to attend meetings with prospective clients in order to win work.

This role would be suitable for someone with at least 10 years’ experience, who is comfortable working on projects with clients who have no or limited internal statistical support, has experience working closely with clinicians and other disciplines and has prior experience providing statistical consultancy advice. The ability to explain statistical concepts to non-statisticians is essential as well as being comfortable presenting to client teams and the ability to present complex ideas in a clear, concise way.

Whilst you will have support from within Veramed as needed, you will need to be comfortable working independently, managing your own workload and working on multiple projects for multiple clients. There will also be an opportunity to support and develop more junior team members and to oversee their work, so an ability to effectively delegate where appropriate is essential.

The following areas of expertise would be beneficial but not essential:

• Study design/sample size experience, simulations, adaptive designs
• Regulatory experience, particularly FDA interactions
• Bayesian methods
• Confident programming in either SAS or R
• Ability to quickly get up to speed with the project requirements and research new TAs or statistical methods as needed

Veramed is a B Corp accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability.

As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment.