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Statistical Programmer

Location: 

Gaithersburg, MD, US, 20879


 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The Statistical Programmer will be responsible for delivering the technical programming components required to support statistical analyses and reporting of data from clinical and pre-clinical studies and pharmacovigilance databases.

 

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

  • Apply bioinformatics knowledge to deliver the technical components supporting analysis, reporting, regulatory submissions, and scientific publications for multiple research projects.
  • Produce datasets, analyses, tabulations, graphics and listings of data from clinical and pre-clinical studies and pharmacovigilance databases, as well as define.xml documentation. For outsourced studies, oversee CRO programming activities to ensure accuracy.
  • Provide expert input to project team activities as needed, such as protocol and CRF development, database design and edit checks, statistical analysis plan and shells, results sections of clinical study reports and regulatory information requests.
  • Lead programming projects for assigned studies, including authoring programming specifications, coordinating other programmers as needed and tracking and documenting of production and validation programs.
  • Contribute to technical programming tool libraries and improvement of standard processes and best practices to enhance quality and efficiency.
  • Update skills continually with respect to evolving industry standards, statistical concepts, regulatory expertise and biological/therapeutic area knowledge.

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS

  • Bachelors’ Degree in statistics, mathematics, computer science or related quantitative field.
  • At least 4 years of extensive experience as a SAS programmer in a pharmaceutical, biotech, CRO or other clinical research setting. Ability to implement standard statistical analyses in SAS. Familiarity with multiple phases of clinical development and therapeutic indications.
  • Working knowledge of GCP, ICH, FDA and HIPAA regulations and guidelines.
  • Experience working with CDISC standards, including SDTM and ADaM. Proficient with development, documentation and testing of analysis data and programming code to meet regulatory and company standards.
  • Experience with SQL, Microsoft Excel, Access and Word. Experience with additional statistical software such as R and JMP is a plus.
  • Excellent organizational, analytical and problem-solving skills, as well as excellent written, verbal, and interpersonal communication skills and the ability to work as part of a team.
     

 

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Washington DC