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Lead Clinical Safety Programmer

Employer
Novavax
Location
Gaithersburg, Maryland, United States
Salary
Competitive
Start date
13 May 2022
Closing date
12 Jun 2022

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

**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.

Summary of the Position :

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 statistical programming and related activities in Phase 1 to 4 clinical trials for aggregate, program-level safety assessments.
  • Develop global programming standards for aggregate safety analyses and reporting, especially for visual/graphical displays.
  • Provide input on the Aggregate Safety Assessment Planning process and Ongoing Aggregate Safety Evaluation plans, especially on programming considerations for safety topics of interest (such as MedDRA coding and SMQs/CMQs) and pooling strategy (such as combining studies and cohorts within studies).
  • Create integrated safety datasets and derive safety topics of interest according to the Aggregate Safety Assessment Planning process.
  • Develop programming for tables, listings and figures in accordance with the Ongoing Aggregate Safety Evaluation plans.
  • 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.
  • Lead safety programming activities for regulatory interactions and submissions, working closely with statisticians, programmers, and regulatory affairs representatives.
  • Collaborate with Biostatistics and Clinical Operations on scientific evaluation of integrated safety data (such as, the IB/RSI, DSUR, RMP, ISS, and CTD).
  • Provide input to general departmental processes and procedures; take part in or lead process initiatives as required by line manager.

Minimum Requirements :
  • BS degree in Statistics, Data Science, Computer Science, or related field.
  • Ten years SAS programming experience (Base SAS, SAS/STAT, and SAS macro language) on clinical trial data for pharma, biotech, or CRO companies.
  • At least 1 year of experience working on data collected from vaccine clinical trials.
  • At least 2 years in a lead role for programming activities within Safety Biostatistics in a pharma, biotech, or CRO company.
  • Programming experience in producing output for periodic safety reports (such as for the SRT, DSMB, DSUR, or ClinicalTrials.gov), or output to support publications.
  • Familiar with CDISC guidance and able to independently create SDTM/ADaM domains and associated specs from clinical data, including for electronic submission of SDTM/ADaM datasets.
  • Familiar with MedDRA coding, including SMQs and CMQs.
  • Experience using the SAS Output Delivery System to output tables, listings, and figures.
  • 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.

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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)

Company

Find out more about working for our company

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Brief Company Description; 

We are a biotechnology company committed to help address serious infectious disease globally through the discovery, development, and delivery of innovative vaccines to patients around the world.

Our mission

We never rest in our quest to protect the health of people everywhere.

Novavax is here to make a difference. We’re a biotech company focused solely on developing life-saving vaccines to fight infectious diseases.

What sets us apart? Solid science tested by decades of research. Vaccines developed from trusted technology that are both safe and efficacious.

And a global network that will help ensure our vaccines reach everyone who needs them.

Company info
Website
Mini-site
Novavax
Location
21 Firstfield Rd
Gaithersburg
MD
20878
United States

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