Sr Principal Stat Programmer

Job responsibilities

Provides statistical programming technical support and expertise across the Biostatistics function and other departments as needed.
Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
Proposes and leads the development of process improvements, programming tools and macros for standardization and efficiency, and the development of new concepts, technologies and products to meet emerging customer needs.
Analyzes information and develops innovative solutions to programming and data analysis challenges across the department.
Reviews, provides input, and promotes standardization of CRFs, databases, Statistical Analysis Plans and mock shells within a project or therapeutic area, or across a program.
Mentors other members of the Biometrics Department in the use of traditional, new, and novel approaches in delivering analytics to sponsors and regulatory agencies through the development and presentation of training courses and one on one discussion.
Understands and enforces compliance with company, regulatory, and industry standards, within and across projects or programs.
May develop or review specifications and may support any kind of statistical programming activity.
Negotiates and establishes accurate time estimates for completion of projects with internal team members and statistical programming management, provides regular status updates, and completes projects within agreed upon timeframe.
Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
May act as primary customer interface representing the department at client meetings; may present status updates at Senior Management meetings.
Displays willingness to work with others, holds project team members accountable, and leads projects and initiatives as necessary to meet the needs of the business.
May provide project oversight to Lead Statistical Programmers across one or more programs.
Maintains extensive working knowledge of clinical drug development, industry standards, and electronic submission requirements.
Actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. May contribute to presentations at industry conferences and roundtables.
When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML)
May lead or support the development of Standard Operating Procedures (SOPs), guidelines, policies, and/or procedures; Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
Supports business development activities by contributing to proposals, requests for information, budgets, and attending sponsor bid defense meetings
Performs other work-related duties as assigned.
Minimal travel may be required.

Qualifications

What we re looking for

Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated technical expertise in programming.
Participation in publications or presentations in areas relevant to programming or industry standards is preferred.
Extensive programming experience in SAS or other required software, preferably in a clinical trial environment, as demonstrated by the ability to develop tools or lead multiple complex and/or global projects with teams of statistical programmers; and effectively work across functional lines to accomplish company-wide goals.
Knowledge and experience in the use of CDISC Standards for regulatory agency requirements.
Experience in submissions to a regulatory agency preferred.
Experience in mentoring others in clinical trial process and CDISC Standards.
Excellent communication, presentation, and interpersonal skills, both written and verbal, with an ability to inform, influence, convince, and persuade.
Ability to read, write, speak, and understand English.