Director, Statistics

The Company

Vaccitech plc is a fast-growing biotech company. At only six years old we already have a development portfolio of nine programmes, including a partnered product that is in commercial production and that has seen more than 3 billion doses administered worldwide and an IPO behind us. We are a publicly listed clinical stage biopharmaceutical company that spun out of the University of Oxford’s Jenner Institute, one of the most prestigious vaccine research centres in the world. We discover and develop immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases, cancer, and autoimmunity. Our achievements include co-inventing and jointly developing our COVID-19 vaccine candidate VTP-900, now Vaxzevria, which we assigned to Oxford University Innovation to facilitate the licensing of those rights to AstraZeneca. We run clinical studies to explore treatments for patients with HBV and HPV infections and are developing rapid and scalable manufacturing processes for our platforms.

In December 2021, Vaccitech acquired Avidea Technologies Inc. with exciting product candidates for oncology and autoimmunity based on the innovative SNAPvax platform, which has demonstrated unprecedented control over T cell induction. This gives us U.S operational presence in Maryland, complements Vaccitech’s established capabilities and reinforces our position as a fast-growing global leader in immunotherapies and vaccines. Vaccitech's UK headquarters has recently moved to a state-of-the-art facility in the UK's leading science and innovation campus at Harwell. We conduct research globally and have ambitious plans in the UK and US, where we will continue to grow our teams over the coming months and years.

The role

Manage various aspects of statistical support at Vaccitech

• Oversee statistical powering and provide input into the design of Vaccitech clinical trials
• Identify potential issues for clinical development programs and associated trials, and provide statistical expertise for relevant issues, as needed
• Perform statistical review of protocols; case report forms (CRFs); clinical study reports (CSRs) and associated tables, listings, and figures (TLFs); Investigator’s Brochures (IBs); scientific manuscripts; and research studies
• Oversee development of Statistical Analysis Plans (SAPs) and associated mock shells for protocols, and act as primary signatory
• Manage statistical vendors, including contract, budget, and quality oversight
• Act on behalf of Vaccitech at DSMB and SMC meetings, as needed
• Provide input into blinding and randomization procedures
• Review animal and research studies for statistical relevance and appropriate sample sizes
• Review and approve trends in manufacturing reports, such as stability studies
• Review qualification experiments that require statistical assessment
• Review statistical validity of toxicology assessments, if needed
• Represent Vaccitech at investigator meetings, international conferences, or presentations, including any regulatory interactions, as needed
• Assist with data transfer agreements, especially in relation to immunology readouts
• Provide input into specimen tracking and blinding
• Assist QA department on relevant guidelines and SOPs
• Keep up to date on new methods and regulatory norms
• Provide statistical review of grant applications

Qualifications and experience required

1. Advanced degree in statistics and at least 20 years of experience
2. Excellent command of English and good communication skills
3. Fluent in SAS, and needed regulatory filing systems
4. Familiar with prophylactic vaccine and/or immune-oncology trial designs and toxicology studies
5. Expected Vaccitech norms of collegiality, integrity, and transparency

What we can offer you

Vaccitech is a great place to work. We encourage an entirely flat structure with an open door policy to the senior leadership team. Our employees agree the culture and working environment is one of the best things about our business. As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us. We offer employer funded health, dental and vision insurance; a 401k retirement plan; career development opportunities and paid time off (PTO). Salary will be commensurate with experience.

Notice to recruiters

Vaccitech’s internal Talent Acquisition leads recruitment and employment for Vaccitech. Unsolicited resumes sent to Vaccitech from recruiters do not constitute any type of relationship between the recruiter and Vaccitech and do not obligate Vaccitech to pay fees should we hire from those resumes. Vaccitech operate a preferred list of recruitment suppliers, any and all enquiries about joining us as a supplier should be directed to Vaccitech’s TA Team. We ask that external recruiters and/ or agencies not contact or present candidates directly to our hiring manager or employees.