Statistical Programmer
Gaithersburg, MD

Job Description

STATISTICAL PROGRAMMER

Emergent BioSolutions is currently seeking a Statistical Programmer. The select candidate will possess a Bachelor's Degree in Statistics, mathematics, computer science or a related quantitative field and a working knowledge of GCP, ICH, FDA and HIPAA regulations and guidelines. In addition, the successful candidate will possess a strong work ethic with a commitment to excellence, innovation, and a drive to lead our organization towards success.

THE COMPANY

Emergent BioSolutions is dedicated to one simple mission-to protect and enhance life.

As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.

We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

THE OPPORTUNITY

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.

DUTIES & RESPONSIBILITIES

* 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.

OUR IDEAL CANDIDATE WILL HAVE

* Bachelors' Degree in statistics, mathematics, computer science or related quantitative field.
* At least 4 years of relevant SAS programming experience 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 SAS, 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.

ADDITIONAL REQUIREMENTS:

* Citizenship/Permanent Resident or Valid Work Permit.
* Successful Completion of a Criminal Record Check.