Sr. Statistical Programmer

Accountabilities •

Develop custom programming code using SAS or other relevant software to produce summary tables, data listings, graphs, and derived datasets in accordance with statistical analysis plans and programming specifications.

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Perform validation programming and quality control activities to ensure outputs meet project requirements, quality standards, and applicable regulatory guidelines, including ICH guidelines.

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Collaborate with programmers, biostatisticians, and other project team members to investigate discrepancies, resolve findings, and communicate programming progress and potential issues.

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Maintain complete, accurate, and up-to-date project documentation, testing records, verification materials, and quality control programs to ensure inspection readiness.

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Develop specifications for datasets and outputs of varying complexity, ensuring they meet statistical and sponsor requirements while anticipating potential programming challenges.

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Manage programming schedules and competing priorities across multiple projects, adapting workloads to changing timelines and management requirements.

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Lead statistical programming activities by coordinating other programming personnel, monitoring deliverables, and ensuring work is completed within agreed timelines.

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Review key project documentation, including Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database designs, providing feedback to improve efficiency and reduce rework.

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Participate in sponsor meetings, project kickoff meetings, and bid defense meetings as the statistical programming representative when required.

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Mentor and support programming colleagues through training development, presentations, work reviews, and guidance for new team members.

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Coordinate internal meetings, communicate project updates, establish realistic delivery estimates, and follow action items through to completion.

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Transfer project deliverables and perform other related duties as assigned.

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Undertake minimal travel when required.

Requirements:

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Undergraduate degree, preferably in a scientific or statistical discipline. Equivalent combinations of education and demonstrated programming experience may also be considered.

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Extensive experience in statistical programming using SAS or other required software, preferably within a clinical trial environment.

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Strong technical capabilities in developing and validating clinical study datasets and statistical outputs.

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Ability to interpret statistical analysis plans, programming specifications, annotated CRFs, and other clinical study documentation.

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Understanding of relevant quality standards, standard operating procedures, work instructions, and regulatory guidelines.

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Strong organizational and time-management skills, with the ability to manage multiple projects, competing deadlines, and changing priorities.

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Excellent written and verbal communication skills, including the ability to collaborate effectively with multidisciplinary and international teams.

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Ability to read, write, speak, and understand English.

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Strong problem-solving, analytical, and leadership skills, with the ability to coordinate programming activities, provide constructive feedback, and mentor colleagues.

Benefits:

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Full-time employment.

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Remote work arrangement available by exception in India.

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Opportunities for career development and professional progression.

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Supportive and engaged line management.

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Access to technical and therapeutic-area training.

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Peer recognition and a total rewards program.

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Collaborative, inclusive, and international working environment.

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Opportunities to work alongside multidisciplinary experts and contribute to clinical research supporting the development of important therapies.

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