Sr Statistical Programmer

Overview

Senior Statistical Programmer who develops SAS (or other software) programming for clinical trial outputs and derived datasets, and acts as lead statistical programmer directing other programming personnel.

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, 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 for internal meetings, contribute ideas, conduct effective internal meetings, distribute relevant information in advance, ensure minutes are promptly distributed, and follow 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 with internal team members and statistical programming management, and complete activities within timeframe allotted.
• Act as the lead statistical programmer: direct the programming activities of other programming personnel and monitor progress on programming deliverables.
• Review project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs and SAS database design, and provide feedback that reduces programming inefficiencies.
• Participate in sponsor meetings, kickoff meetings and bid defense meetings as statistical programming representative, as required by sponsor.
• Contribute to mentoring programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or 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 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: IND-Remote.
• Minimal travel may be required.