Lead Clinical Safety Programmer
See your future through a different lens
**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.**
If you find science, speed, and success exhilarating, you have come to the right place.
Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.
Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
Novavax is currently seeking a Lead Clinical Safety Programmer to join our Clinical Safety Statistics group to be located in Gaithersburg, MD or to be remote. The successful candidate will lead 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.
Responsibilities include but are not limited to:
- Lead safety statistical programming team to deliver timely and high-quality TLFs for clinical trials or integrated safety reports.
- Coordinate and 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.
- Lead safety programming activities for regulatory submissions/requests, periodic safety review, and ad hoc/post hoc analysis.
- Review statistical document including SAP, and TLF Mock shells to provide statistical programming feedback.
- Create integrated safety datasets and derive datasets to address the safety topics of special interests.
- Directly support the analytic requirements of Clinical Safety Statistics projects, including statistical programming for the creation of data and TLFs.
- Develop programming standards, process, and system to streamline Clinical Safety Statistics deliverables and enhance quality, accuracy, and reproducibility.
- Create programing documents, such as, ADaM/SDTM specifications, SOP, guidance, etc., to follow regulatory document requirement, guide other statistical programmers and share best practices.
- Instruct and supervise programming activities for Clinical Safety Statistics projects that are out-sourced to CROs, and manage performance to ensure the quality of delivery from CROs.
- Plan work across multiple and/or large/complex Clinical Safety Statistics projects and coach less experienced statistical programmers.
- Maintain all documentation of programming activities in accordance with SOPs/Guidance/process to ensure traceability and regulatory compliance.
- MS. (BS) degree in Statistics, Biostatistics, Computer Science, Epidemiology, Mathematics, or related field.
- 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.
- At least 6 years application on clinical trial data for pharma, biotech, or CRO companies.
- At least 3 years in a lead role for programming activities in clinical trials.
- 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.
- Project management skills including time management, code validation management, document versioning, maintaining minutes of meetings, and coordinating the team activities.
- Good verbal and written communication skills, detail orientated, able to work comfortably with tight deadlines.
- Positive attitude, team player and growth mindset.
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Gaithersburg, Maryland, USA
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