Senior Clinical Safety Programmer
Gaithersburg, MD 
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Posted 1 day ago
Job Description

If you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place.

Individually, we're skilled, driven, and confident risk-takers.Collectively we're collaborative and accomplished. We're SuperNovas! Together we use our unique experiences, cultures, and learnings to turn innovation into reality while maintaining the highest standards. We value balance, encourage growth, and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you!

Novavax, Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery, development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world's most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research, has tremendous potential to make a substantial contribution to public health worldwide.

Novavax is currently seeking a Senior Clinical Safety Programmer to join our Clinical Safety Statistics group to be located in Gaithersburg, MD or to be remote. The successful candidate will develop statistical programming and related activities in Phase 1 to 4 clinical trials for aggregate, program-level safety assessments. This position will report to the Senior Director, Safety Statistics in Global Vaccine Safety. We will partner together with clinical safety professionals in Aggregate Safety Assessment Planning and Ongoing Aggregate Safety Evaluations.

Essential Functions:

  • Deliver timely and high-quality TLFs for clinical trials or integrated safety reports.
  • Collaborate with other functions including epidemiologists, biostatisticians, data managers, regulatory affairs, etc., to ensure that programming deliverables meet scientific specifications, project timelines, and regulatory requirements.
  • Develop statistical programming to implement the analyses specified in the SAP with the TLF requirement.
  • Directly support the analytic requirements of Clinical Safety Statistics projects, including statistical programming for the creation of data and TLFs.
  • Develop standard macro to streamline Clinical Safety Statistics deliverables and enhance quality, accuracy, and reproducibility.
  • Create programing documents, such as, ADaM/SDTM specifications, SDRG/ADRG, etc., to follow regulatory document requirement.
  • Maintain all documentation of programming activities in accordance with SOPs/Guidance/process to ensure traceability, accuracy and regulatory compliance.

Required Knowledge, Skills, and Abilities:

  • Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL preferably proficiency with additional statistical software or applications, e.g. R, R Shiny.
  • Programming experience in producing output for safety reports, such as for the ISS, RMP, IB, DSUR, or ClinicalTrials.gov.
  • Familiar with relevant industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, Pinnacle 21, and FDA guidelines.
  • Good verbal and written communication skills, detail orientated, able to work comfortably with tight deadlines.
  • Positive attitude, team player and growth mindset.

Education, Experience, Licenses & Certifications

  • MS. (BS) degree in Statistics, Biostatistics, Computer Science, Epidemiology, Mathematics, or related field.
  • At least 4 years application on clinical trial data for pharma, biotech, or CRO companies

Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
Open
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