ABOUT ITEOS THERAPEUTICS SA
iTeos Therapeutics is a publicly-held (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing next generation immunotherapies.
Based in Gosselies, Belgium and Cambridge, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UCLouvain) in 2011.
In March 2020, the Company completed a $125 million Series B2 financing, and in July 2020, we completed our IPO raising over $200million of proceeds.
This additional capital will allow us to continue to develop our clinical pipeline and maintain our investments in our discovery research team to leverage its fantastic science to improve the lives of cancer patients.
For more information, please visit www.iteostherapeutics.com.
ROLE: Director of Biostatistics
The Director of Biostatistics is accountable for all biostatistics activities and deliverables for two clinical development projects in mid-stage clinical development, and oversees relevant biostatistics activities conducted by contract research organizations (CROs) and contractors. You will provide direction and oversight on clinical development plans, protocols and analysis, reviews clinical study reports and regulatory submission materials, and ensures the adherence to standard procedures. You will also provide direct contributions as appropriate to complex statistical analysis plans and interim analysis approaches to gain alignment across organization.
The Director of Biostatistics builds and maintains strong collaboration with key stakeholders from different disciplines across the organization to facilitate agile and robust clinical development plans and decision frameworks, represents Biostatistics in meetings with executive committee, regulatory agencies, advisory boards and external development partners as appropriate. You will oversee the relevant biostatistics activities and ensures consistent statistical approaches across teams and external collaborators. You will also provide leadership on biostatistical approaches including driving process improvement initiatives and enhancing the technical capabilities of the organization, as appropriate.
- Directs overall statistical activities for the clinical and preclinical projects including implementing efficient, consistent, and practical processes for Biostatistics and develops, implements and monitors resource allocation and usage for assigned projects
- Provides oversight and guidance for all biostatistical resources in assigned projects to ensure that the Biostatistics goals are achieved. Assesses and makes recommendations on internal and external biostatistical resources required to execute the project plans.
- Provides guidance and direct input in addressing statistical issues arising from regulatory, legal or other challenges to the company's products or processes and represents the biostatistics of the company in key regulatory meetings and meetings with KOLs
- Participates in and/or leads cross-functional initiatives representing biostatistics. Participates in key internal governance meetings
- Provides guidance and direct input into strategy, planning and contents of clinical development plan as well as key components of regulatory submissions. Strives to increase the scientific agility through proposal and implementation of innovative approaches and to increase operational efficiency by close monitoring of the operating procedures and strategies for Biostatistics. Serves as the primary functional reviewer of protocols, analysis plans, and clinical study reports
- PhD or MSc in Biostatistics/Statistics or equivalent with a minimum of 10 years relevant work experience
- Substantial past regulatory experiences, including interactions with FDA, EMA, and PMDA and BLA/NDA/MAA submission experiences.
- Extensive experience working on oncology clinical trial from Phase I through to Phase III
- Experience in a pharma research environment in experimental set-up, power calculation, statistical analysis and reporting of preclinical data would be an advantage
- Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them
- Ability to develop innovative/creative statistical/technical solutions to complex problems
- Expertise in the design and application of a range of clinical trial designs, including adaptive designs and phase II/III trials.
- Knowledge and experienced in meeting regulatory guidance, both FDA and international regulatory agencies
- Broad knowledge of medical/biological terminology and clinical trial design in relevant therapeutic areas
- Strong verbal and written communication skills. able to explain methodology and consequences of decisions in lay terms
- Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflicts resolutions, and effective partnership
- Strong people manager with track record of staff development and/or significant experience providing oversight of external resources
- A stimulating position within a high-potential innovative biotech company
- The opportunity to work in a science-driven, dynamic, human‐sized, respectful and professional environment
- A challenging scientific and business growth in which you get to bring your knowledge and skills
- An attractive salary package in line with the position responsibilities and your experience
Please send your CV together with an adapted cover letter to the following address : email@example.com. Please, mention the reference DB in the mail object. Your application and related information will remain strictly confidential.
For our recruitments in USA, we closely collaborate with a Recruitment & Selection company, Planet Pharma. Your application will be automatically forwarded to them. We, together with Planet Pharma, will keep all your data confidential (GDPR compliant approach).