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India
Onsite
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Statistical Programmer based in India.
As a Senior Statistical Programmer, you will play a key role in supporting clinical development projects by transforming complex clinical data into accurate, reliable, and high-quality statistical outputs. Using SAS and other relevant programming tools, you will develop and validate datasets, tables, listings, and graphs in accordance with statistical analysis plans and project specifications. You will collaborate with biostatisticians, programmers, and cross-functional teams to ensure deliverables meet quality standards and regulatory requirements. The role also involves taking the lead on programming activities, coordinating project deliverables, and providing technical guidance and mentorship to colleagues. Working across multiple projects in a dynamic, international environment, you will contribute to the efficient delivery of clinical research and the advancement of important therapies.
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.
Perform validation programming and quality control activities to ensure outputs meet project requirements, quality standards, and applicable regulatory guidelines, including ICH guidelines.
Collaborate with programmers, biostatisticians, and other project team members to investigate discrepancies, resolve findings, and communicate programming progress and potential issues.
Maintain complete, accurate, and up-to-date project documentation, testing records, verification materials, and quality control programs to ensure inspection readiness.
Develop specifications for datasets and outputs of varying complexity, ensuring they meet statistical and sponsor requirements while anticipating potential programming challenges.
Manage programming schedules and competing priorities across multiple projects, adapting workloads to changing timelines and management requirements.
Lead statistical programming activities by coordinating other programming personnel, monitoring deliverables, and ensuring work is completed within agreed timelines.
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.
Participate in sponsor meetings, project kickoff meetings, and bid defense meetings as the statistical programming representative when required.
Mentor and support programming colleagues through training development, presentations, work reviews, and guidance for new team members.
Coordinate internal meetings, communicate project updates, establish realistic delivery estimates, and follow action items through to completion.
Transfer project deliverables and perform other related duties as assigned.
Undertake minimal travel when required.
Undergraduate degree, preferably in a scientific or statistical discipline. Equivalent combinations of education and demonstrated programming experience may also be considered.
Extensive experience in statistical programming using SAS or other required software, preferably within a clinical trial environment.
Strong technical capabilities in developing and validating clinical study datasets and statistical outputs.
Ability to interpret statistical analysis plans, programming specifications, annotated CRFs, and other clinical study documentation.
Understanding of relevant quality standards, standard operating procedures, work instructions, and regulatory guidelines.
Strong organizational and time-management skills, with the ability to manage multiple projects, competing deadlines, and changing priorities.
Excellent written and verbal communication skills, including the ability to collaborate effectively with multidisciplinary and international teams.
Ability to read, write, speak, and understand English.
Strong problem-solving, analytical, and leadership skills, with the ability to coordinate programming activities, provide constructive feedback, and mentor colleagues.
Full-time employment.
Remote work arrangement available by exception in India.
Opportunities for career development and professional progression.
Supportive and engaged line management.
Access to technical and therapeutic-area training.
Peer recognition and a total rewards program.
Collaborative, inclusive, and international working environment.
Opportunities to work alongside multidisciplinary experts and contribute to clinical research supporting the development of important therapies.