Principal Statistical Programmer; US, CAD

Principal Statistical Programmer (US, CAD, UK only)

Updated:
Today

Location:

London, LND, United Kingdom
Job :

-OTHLOC-3526-2DR

Must be located in US, CAD, UK with no sponsorship needs.
Hiring at Sr level only for NA.

• Graph experience, plus experience writing specifications for ADaM datasets is required.
• 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 project team members to resolve discrepancies or findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follows 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, sets goals based on management priorities, and adapts to timeline or priority changes by reorganizing daily workload.
• Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements, anticipating and addressing potential programming issues, reflecting forethought and minimizing rework.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for the opinions of others.
• Conduces 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.
• Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within the allotted timeframe.
• Acts as the lead statistical programmer, directing the programming activities of other programming personnel and monitoring progress on programming deliverables.
• Reviews project documentation such as the Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design, providing feedback that reflects forethought and reduces inefficiencies.
• Participates in sponsor meetings, kickoff meetings, and bid‑defense meetings as the 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 guidance to new associates.
• Transfers deliverables.
• Performs other work‑related duties as assigned.
• Minimal travel may be required.

• Undergraduate degree, preferably in a scientific or statistical discipline; or an equivalent combination of education and demonstrated programming experience.
• Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.
• Extensive experience in ADaM specification writing and SAS Graph programming.
• Excellent written and verbal communication skills.
• Ability to read, write, speak and understand English.

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 equivalent to the qualifications described above.

Further, nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.