WHY WORK FOR ARCTURUS?

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global, late-stage clinical mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology (samRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat ornithine transcarbamylase (OTC) deficiency, and cystic fibrosis, along with partnered programs including glycogen storage disease type III, and hepatitis B virus. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (patents and patent applications issued in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations including, amongst others, Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., and the Cystic Fibrosis Foundation.

Arcturus Therapeutics is presently recruiting outstanding candidates with experience in the field of mRNA technologies and nanoparticle sciences. Our corporate culture is dynamic, diverse, and creative. We value collaboration and teamwork. We seek individuals to join us with a genuine passion for the science behind helping to cure disease and improve the lives of patients.

THE OPPORTUNITY

The statistician is responsible for contributing to the design, analysis, and interpretation of Arcturus clinical vaccine studies and other Arcturus programs. The statistician would collaborate across the range of development, engaging in cross-functional support and working closely with regulatory, bioanalytical, and clinical functions. You will also provide management and oversight to external statisticians and programmers. In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.

WHAT YOU WILL CONTRIBUTE

• Providing statistical input to the design, analysis, reporting, and interpretation of clinical studies for assets
• Leading development or contributing to study protocols, statistical analysis plans, study data standardization plans, clinical study reports, ISS, ISE, and other documents and submissions
• Driving design, execution, and analysis of the clinical program in partnership with Clinical Development, Clinical Operations, Program Management, Bioanalytical, Regulatory, Clinical Trial Supply functions and outsourced Development functions, Clinical Research Organizations
• Overseeing/conducting ongoing statistical review of clinical trial data. This includes accountability for the interpretability (characterization of safety and efficacy), reportability (emerging issues), and accuracy of emerging study data.
• Responsible for ensuring complete and professional outsourcing of biostatistical support if needed by a specific project
• Ad hoc analysis of study data and existing literature in support of development programs
• Supporting Pharmacovigilance and Clinical in ensuring overall safety and efficacy of the vaccine portfolio
• As a statistical expert, supporting the SVP Clinical Development and the Chief Medical Officer in interactions with external and internal stakeholders and decision boards
• Management and oversight of external statistical vendors (including compliance checks) supporting various deliverables across the program.
• Drive development of statistical reporting standards across the organization

WHAT WE SEEK

• Advanced degree in statistics or related field is required (PhD is strongly preferred).
• Minimum requirement for years of experience in clinical research or drug development will be commensurate to level.
• Working knowledge of vaccines is desired with proven ability to analyze, interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
• Previous experience with CBER submissions strongly preferred
• Strong communication skills with the ability to work in a cross functional and global organization required.

EDUCATION

• Advanced degree in statistics or related field is required (PhD is strongly preferred).

WHAT WE OFFER

An exciting opportunity to join a company that offers a competitive total rewards package that includes:

• Full range of health benefits including Medical, Dental & Vision with 100% EMPLOYER PAID premiums for employee and family!
• 401k Match
• Employee Stock Purchase Program (ESPP)
• Competitive salaries and bonus plans plus equity via Stock Options
• Catered lunches
• Free variety of snacks and beverages
• Health and Wellness programs
• $100 Anniversary cash awards with opportunity to increase to $2000!
• Referral Bonuses
• On Campus Gym
• Company sponsored FUN events
• Education reimbursement

For a deeper dive into our company and corporate culture visit www.ArcturusRx.com

Arcturus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.