Senior Statistical Programmer

Overview

Senior Statistical Programmer who develops SAS (or other software) programming to produce clinical study outputs and derived datasets, and who acts as lead statistical programmer on projects.

What you'll do

• Develop custom programming code using SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
• Ensure outputs meet quality standards and project requirements.
• Perform validation programming and work with Programmers, Biostatisticians and other project team members to resolve discrepancies or findings.
• Keep project team members informed of programming progress and issues requiring their attention.
• Follow applicable SOPs, WIs and relevant regulatory guidelines (e.g. ICH).
• Maintain well organized, complete and up-to-date project documentation, testing and verification/quality control documents and programs, ensuring inspection readiness.
• Manage scheduling and time constraints across multiple projects, set goals based on management priorities, and adapt to timeline or priority changes by reorganizing daily workload.
• Develop specifications for datasets and outputs of any complexity according to statistical and sponsor requirements.
• Anticipate and address potential programming issues and accurately define all variables to be accepted by peer review and sponsor/requestor with little rework.
• Prepare in advance for internal meetings, contribute ideas, and conduct effective internal meetings, distributing information and minutes and following action items through to completion.
• Work with others and assist with projects and initiatives as necessary to meet business needs.
• Negotiate and establish accurate time estimates for study programming activities and complete them within the allotted timeframe.
• Act as lead statistical programmer: direct the programming activities of other programming personnel and monitor progress on deliverables.
• Review project documentation such as the Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs and SAS database design, and provide feedback to project team members.
• Participate in sponsor meetings, kickoff meetings and bid defense meetings as statistical programming representative, as required by the sponsor.
• Contribute to mentoring programming personnel through developing training courses, presenting training materials, reviewing work, and guiding new associates.
• Transfer deliverables and perform other work-related duties as assigned.

What you'll need

• Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of a 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.
• Excellent written and verbal communication skills.
• Ability to read, write, speak and understand English.

Details

• Location: India, remote.
• Minimal travel may be required.