Principal Statistical Programmer

Location
Gaithersburg, MD, US
Posted
Nov 06, 2020
Ref
689827200
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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.

Position Summary

This role is an integral part of the statistical programming department and the research and development capability of Emergent. The Principal Statistical Programmer is responsible for implementing all aspects of clinical/pre-clinical study data and pharmacovigilance analysis as defined by the study Statistician. The tasks are for creation of submission ready deliverables for regulatory agencies for analysis conducted in house, and for liaising with data management to specify review tools for ongoing studies and oversee their creation. This role is also responsible for project management, such as timelines for statistical programming activities, and managing CROs and less senior or contract programming team members; creation and refinement of processes and procedures for continuous improvement and infrastructure development for statistical programming activities and providing input for related activities such as biostatistical or data management processes. This role may involve supervision or matrix management.

Essential Functions

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

  • Apply analytical knowledge to deliver the technical components supporting analysis, reporting, regulatory submissions, and scientific publications.
  • Produce/validate datasets, tables, listings, graphics, and other submission deliverables of data from clinical and pre-clinical studies including define.xml, reviewer's guides, SDTM annotated CRFs, and computational methods documentation.
  • Responsible for creating/reviewing SDTM/ADaM mapping specifications.
  • Act as a Programming SME for assigned studies, including authoring/reviewing programming specifications, documenting production and validation programs.
  • Independently manage programming activities on multiple studies, including managing CROs to ensure deliverables are accurate and compliant. Manage a project resources and timelines.
  • Provide leadership and vision for the creation and validation of standard global SAS macros and utilities to automate standard and frequent tasks to enhance quality and efficiency.
  • Increased responsibility for development of statistical programming SOPs and standard processes.
  • Independently review and provide input on documents produced by other functions such as protocols, CRFs, SAPs, mock TFLs, DMPs, Randomization Plans, DSMB/SMC charters, and CSRs.
  • Lead the programming effort by working collaboratively with Biostatistics, Clinical Operations and Clinical Development, Data Management, and Regulatory to meet project deliverables and timelines for statistical data analysis and reporting for both in-house and outsourced projects.
  • Manage the interactions with Biostatistics and other functions for the development and maintenance of programming standards, the data review and reporting tools, and any other statistical applications as appropriate.
  • Mentor Data Management and Statistical Programming staff on data standards as relevant to their roles
  • Update skills continually with respect to evolving industry standards, statistical concepts , regulatory expertise and biological/therapeutic area knowledge.

    Minimum Education, Experience, Skills
  • Bachelor's degree in statistics, mathematics, computer science or related quantitative field.
  • At least 12 years of relevant SAS programming experience in a pharmaceutical industry or other clinical research setting.
  • Advanced SAS programming ability to implement standard statistical analyses. Lead experience in developing SAS macros to standardize the workflow and internal processes.
  • Intensive hands-on experience with multiple phases of clinical development. Familiar with expectations of regulatory agencies, especially FDA and EMA. Experience of NDA/BLA or other regulatory filing is a plus.
  • Intensive experience and working knowledge of GCP, ICH, FDA and HIPAA regulations and guidelines.
  • Hands-on experience and in-depth knowledge in CDISC standards, including SDTM and ADaM, controlled terminologies, aCRF, cSDRG, ADRG, and define.
  • Excellent with development, documentation and testing of analysis data and programming code to meet regulatory and company standards.
  • Excellent organizational, analytical and problem-solving skills, ability to prioritize tasks, as well as excellent written, verbal, and interpersonal communication skills.
  • Supervision and management of statistical programming staff and contractors is a plus.
  • Experience with additional statistical software such as R and JMP is a plus.
  • Project Management experience of leading multiple studies is required, experience of leading programming initiative is a plus


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.

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