Senior Director - Biostatistics

About HOOKIPA:

HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA's replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ cell responses and pathogen-neutralizing antibodies. HOOKIPA's pipeline includes its wholly owned investigational arenaviral immunotherapies targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed programs. In addition, HOOKIPA aims to develop functional cures for HBV and HIV in collaboration with Gilead.

Position Summary:

The Senior Director Biostatistics is the strategic leader regarding all aspects of biostatistical and data management activities to support drug development including innovative trial designs, real world data generation and supporting regulatory approvals

Main Responsibilities:

• Developing innovative ideas of trial designs, real world data generation supporting regulatory approvals

• Provide statistical input to the clinical development plan

• Drive the design of clinical trials, including the definition of the study objectives, the selection of populations to enrol, the endpoints to use and the appropriate methodology to apply for supporting regulatory approval and market access

• Author and/or review protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents

• Collaborate with clinicians and medical writers to prepare clinical study reports, health authority briefing books, IND applications and updates, drug safety reports, first interpretable results, regulatory dossiers, scientific publications, etc.

• Interact with members of project teams to establish project activities and timelines

Qualifications & Skills:

• Minimum of 10 years relevant professional experience

• Able to write/describe statistical models of moderate complexity

• Organizational awareness, including experience working cross-functionally and in global teams with good strategic thinking skills

• Ability to resolve issues with minimal supervision and understand when to escalate

• Excellent supervisory, organizational and communication skills

• Strong interpersonal skills

• Demonstrated change agile mind-set

• Fluent English (oral and written)

• Track record of building high-performing teams of biostatisticians and data managers

• Track record of health authority interactions, FDA advisory committee meetings, EMA scientific advice meetings, etc.

• Knowledgeable in Real World Data generation to support innovative drug approvals

What we offer:

• Strong team with dedicated and passionate employees

• State of the art infrastructure

• An excellent working atmosphere

• Opportunities for personal development

• Employee benefits such as health screening, public transportation card, Sodexo pass

• Working in a multinational and multicultural environment

• Possibility to work remotely 2 days per week

We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 6.200 € based on fulltime (40 hours per week, 14 monthly installments); depending on experience and qualification the salary can be negotiated. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.

Starting date: As soon as possible

Contact:

If you are interested in this challenging position, please send us your CV including a cover letter (summarizing your qualification and experiences) together with your credentials.

For more information on HOOKIPA please visit www.hookipapharma.com

Contact:

Contact:

If you (m/f) are interested in this challenging position, please send your CV including a cover letter summarizing your qualification and experiences to: talent@hookipabiotech.com

For more information on HOOKIPA please visit www.hookipabiotech.com