JOB SUMMARY

This position functions as a member of the Biostatistics and Statistical Programming project team serving as a lead statistical programmer or reviewer for any project, especially those of high complexity and scope, or integrated summaries of safety/efficacy for submission, in the development of programs to support the conduct, statistical analysis and reporting of projects; creates, tests, and maintains programs for clinical studies, coordinating the efforts of other programming personnel; determines the overall strategy for the programming tasks on a project or across a program or submission; manages project budgets and tracks project specific performance metrics; functions as an internal and external customer liaison; provides input to statistical analysis plans; leads the creation and maintenance of statistical programming project documentation and regulatory submission packages utilizing SDTM guidelines to build datasets . A Principal Statistical programmer demonstrating a high degree of expertise of CDSIC (SDTM) and other industry standards / tool and regulatory requirements may serves as a subject matter experts leading innovations and providing guidance to the Biostatistics Department.

JOB RESPONSIBILITIES

• 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.
• Works to ensure that outputs meet quality standards and project requirements.
• Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
• Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
• Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
• Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.
• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
• Accountable for on- time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions.
• Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables.
• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
• Review protocols, CRFs, annotated CRFs, test databases and Statistical Analysis Plans Develop, test and produce CDISC SDTM/ADAM datasets, derived datasets. Validate them primarily using SAS software, derived datasets, tables, listings and graphs for clinical study reports.
• Supporting project teams in creating SDTM deliverables.
• Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
• Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.
• Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions.
• Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures.
• Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.
• When serving as a technical subject matter expert for CDSIC(SDTM) and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDSIC(SDTM) Standards
• 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).
• When serving as a subject matter expert for CDSIC (SDTM) and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards.
• Transfers deliverables.
• Performs other work-related duties as assigned.
• Minimal travel may be required

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.QUALIFICATION REQUIREMENTS

• Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.
• Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers.
• Knowledge and experience in the use of CDSIC (SDTM) Standards for regulatory agency requirements.
• Knowledge and experience in the use of SDTM guidelines to build datasets.
• Experience in submissions to a regulatory agency preferred.
• Experience in mentoring others in clinical trial process and CDSIC (SDTM) Standards.
• Excellent written and verbal communication skills.
• Ability to read, write, speak and understand English.