Manager/Senior Manager Statistical Programming

Full Time On-Site/Hybrid Biostatistics Manager Statistical Programming Apply for this Job 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

We are seeking a talented Team Leader in Statistical Programming who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver vaccines and life-changing therapies to people.

You will provide technical expertise and leadership to the department of biometrics, as well as developing process methodology for the department to meet internal and external needs. All whilst working for a smaller company where your work will have a larger impact.

This position will work closely with the Vice President of Biostatistics and Executive Director of Data Management and Statistical Programming and other members of the clinical, pharmacovigilance and regulatory affairs teams to provide programming support across all programs. The ideal candidate will provide hands-on programming and validation support to project teams and oversee external vendors to ensure timely and accurate deliverables. This role will provide technical expertise to the development of programming standards and procedures.

WHAT YOU WILL CONTRIBUTE

• Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices.
• Develops unambiguous and robust programming specifications (e.g. SDTM, ADaM specifications)
• Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files.
• Strong knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) and experience with MS Office are required. Familiarity or experience with R Software is a plus.
• Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
• Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
• Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications under supervision of biostatisticians.
• Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
• Maintain complete and auditable documentation of all programming activities.
• Review CRFs, edit check specifications, and table mock-ups.
• Participates in monitoring CRO activities and reviewing CRO deliverables, as necessary.
• Other duties as assigned.
• Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP).
• Submission support with compliance experience.
• Understanding of the software development life cycle.

WHAT WE SEEK

• Strong professional experience in a similar role within the pharmaceutical industry, preferably vaccines.
• Ability to effectively communicate and perform in a high demand and dynamic working environment.
• Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
• Works effectively with cross functional groups, study team, and vendors.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
• NDA submission experience is a plus.
• Bachelor’s degree in Statistics, Computer Science, Mathematics, or related technical discipline. Equivalent combination of education and applicable job experience may be considered.
• Minimum of 5 years’ experience in clinical research, ideally as a SAS programmer for phase I-IV clinical trials in a pharmaceutical/CRO environment.

EDUCATION

Bachelor’s degree in Statistics, Computer Science, Mathematics, or related technical discipline. Equivalent combination of education and applicable job experience may be considered.

WHAT WE OFFER

At Arcturus Therapeutics, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family, and wellbeing journey while providing flexibility and resources to support their growth and aspirations. Our total rewards package 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
• The anticipated salary range for candidates at Senior Manager level who will work in San Diego is $150,000.00 to $200,000.00.

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Arcturus Therapeutics is multi state employer and this salary range may not reflect positions that work in other states. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.

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