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Head of Statistical and Data Innovation as Head of Biometrics

Autolus Therapeutics

We are actively hiring for this exciting role Head of Statistical and Data Innovation as Head of Biometrics

 

This role will be based in Mediaworks, WhiteCity, West London  

Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies. The company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognise cancer cells, break down their defence mechanisms and eliminate these cells.

 

Autolus has a pipeline of products in development for the treatment of haematological malignancies and solid tumours.

 

Head of Statistical and Data Innovation  (Head of Biometrics) 

In this highly visible role, the Head of Statistical and Data Innovation will act as Head of Biometrics and will be required to build a biometrics team capable of managing multiple development projects within haem-oncology and solid tumour in the CAR T cell setting.

 

This is a leadership role and the successful candidate will lead and provide innovation to the Biometric function. The successful candidate will implement new methodological approaches to improve design and decision making in the development, engaging in the external environment to shape and access innovation.

 

Candidate Focus and Challenge

·         Accountable for the project management, complete oversight and timely delivery of clinical trial data and documentation according to agreed timelines, budget and quality requirements.

·         Identify and drive the development & utilisation of leading-edge statistical methodology, skills, capabilities, tools, processes & best practice, in order to add value

·         Provide an overall analytics strategy, and provide senior level technical expertise regarding Data and Statistical capabilities and solutions.

·         Achieve the most effective development of the statistical and Data innovation skill & staff, including recruitment.

·         Develop collaborative relationships with external data management vendor (s)

·         Steer and support development & maintenance of any required tools and processes that meets regulatory requirements.

·         Collaboration with medical, clinical and regulatory colleagues within the project team setting to develop the biometrics strategy for all Autolus global CAR T cell programmes for subsequent regulatory submissions (FDA, EMEA and Asia-Pac).

·         Ownership, review and ongoing management via the vendor of data management plans (DMPs), Statistical Analysis Plans (SAPs), Databases, Master eCRFs and all data management documentation.

·         Authoring, review and sign-off of Statistical Analysis Plans including design of TLFs.

·         Oversight of preparation of statistical outputs including interpretation of results of statistical analyses.

·         Statistical input into Clinical Study Reports and submission documents including preparation of statistical methods and results sections incorporating statistical conclusions.

·         Response to relevant statistical questions from regulatory authorities.

·         Statistical representative on Programme/Project Team.

·         Attendance at regulatory meetings as key statistical expert.

  

Candidate Knowledge, Skills and Experience

·         Statistical/mathematics discipline with proven experience of working with a Pharmaceutical/CRO/Biotechnology organisation, in a similar leadership role.
·         7-10+ years of relevant professional experience in an Oncology clinical trials environment.

·         Extensive experience of working as a Statistical/Data Management leader in drug development.

·         Ability to communicate complex statistical concepts to non-statisticians.

·         Demonstrable leadership, project management, and interpersonal skills.

·         Self-starter with the ability to work on a cross-functional team.

·         Line Management experience.

·         Good knowledge of CDISC standards.

·         Data Management/Project Management skills - demonstrates understanding and quality delivery of study/data management milestones according to established timelines.

·         Demonstrate strong problem solving and judgement skills.

·         Demonstrate professional communication skills - strong oral and written English.

 

Life at Autolus 

Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy to deliver life-changing treatments to patients.

 

At Autolus, you will enjoy a flexible, diverse and dynamic working environment which fosters creativity, leadership and teamwork.

 

Please apply for this role on Autolus website : https://autolus.ciphr-irecruit.com/templates/CIPHR/jobdetail.aspx?raparam=4E65586A74674B302F306B707744354569524D4A616F434C6F664E61756F71325148694A626E41514C396F75456B71705270343753773D3D

 

Alternatively for further information please contact Amisha Seda 07443879337 or email a.seda@autolus.com 

 

Autolus is an equal opportunity employer committed to a culturally diverse team.


We look forward to receiving your application!