Senior Statistical Programmer
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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.
Summary of the Position:
Novavax is currently seeking a Senior Statistical Programmer to join our Biostatistics group located in Gaithersburg, MD.
Responsibilities include programmatically support all statistical programming and related activities in Phase I - Phase III clinical trials for seasonal flu and COVID19 vaccines, as well as, writing SAS programs from instructions provided by Biostatisticians to create CDISC datasets as well as tables, figures, and listings of clinical trials for vaccine studies.
Responsibilities include but are not limited to:
- Programmatically support all statistical programming and related activities in Phase I - Phase III clinical trials for seasonal flu and COVID19 vaccines.
- Writing SAS programs from instructions provided by Biostatisticians to create CDISC datasets as well as tables, figures, and listings of clinical trials for vaccine studies.
- Create and validate SAS datasets to map data exported from database (such as CSV files) according to specifications.
- Collaborate with Biostatistics and Clinical Operations on edit checks or data review.
- Provide input to general departmental processes and procedures; take part in or lead process initiatives as required by line manager.
- Provide programming support for the qualification and validation of immunological assays.
- BS degree in Statistics, Computer Science, or related field.
- Eight to eleven years SAS programming experiences (Base SAS, SAS/STAT, and SAS macro language) on phase I, II, or III clinical trial data, in creating/validating SAS datasets and TFLs (per SAP/table shell/specs) for CSR in pharmaceutical, biotech, or CRO companies.
- Programming experience in producing outputs for periodical safety report (such as SRT, DSMB, DSUR, or ClinicalTrials.gov), or outputs to support publications.
- Experience creating CDISC SDTM/ADAM domains, as well as associated specs, from phase I/II/III clinical trial data.
- Experience using the SAS Output Delivery System to output figures, tables and listings.
- Good verbal and written communication skills, detail orientated, able to work comfortably with tight deadlines.
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.
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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