Sr. Statistical Programmer

IndiaRemoteFull-timesenior

Other

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Quick Summary

Key Responsibilities

Bachelor's degree, preferably in a scientific, statistical, mathematical, or related discipline. Equivalent combinations of education and relevant professional experience will also be considered.

Technical Tools

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As a Senior Statistical Programmer, you will play a key role in transforming clinical trial data into accurate, meaningful statistical outputs that support medical research and drug development. You will develop, validate, and maintain complex statistical programs to generate tables, listings, figures, and analysis datasets. Working closely with biostatisticians, clinical teams, and other programming professionals, you will ensure the accuracy, quality, and regulatory compliance of clinical study deliverables. You will also take a leadership role in coordinating programming activities, reviewing deliverables, and mentoring junior team members. This position offers the opportunity to contribute to international clinical research projects within a collaborative, science-driven environment. Your expertise will help accelerate the development of innovative treatments and ultimately improve patient outcomes worldwide.

Develop and maintain statistical programming code using SAS or other relevant software to generate summary tables, data listings, graphs, and derived datasets in accordance with Statistical Analysis Plans (SAPs) and programming specifications.
Perform independent validation programming and quality control activities to ensure the accuracy, consistency, and reliability of statistical outputs.
Review and interpret study documentation, including Statistical Analysis Plans, mock shells, annotated Case Report Forms (CRFs), programming specifications, and database designs.
Lead statistical programming activities across assigned clinical projects, coordinating deliverables, monitoring progress, and ensuring completion within agreed timelines and quality standards.
Develop programming specifications for datasets and outputs of varying complexity, anticipating technical challenges and establishing efficient programming approaches.
Maintain accurate, organized, and inspection-ready project documentation, including testing records, verification reports, and quality control documentation.
Collaborate closely with biostatisticians, fellow programmers, and cross-functional project teams to investigate discrepancies, resolve technical issues, and communicate progress and potential risks.
Manage competing priorities across multiple projects, negotiate realistic delivery timelines, and adapt workloads to changing project requirements.
Participate in sponsor meetings, project kickoffs, and bid defense meetings as the statistical programming representative when required.
Mentor and support junior programming professionals through technical guidance, peer reviews, training sessions, and constructive feedback.
Contribute to continuous improvement initiatives, knowledge sharing, and the development of efficient programming practices while ensuring compliance with applicable SOPs, work instructions, and regulatory guidelines, including ICH requirements.
Support the successful transfer of project deliverables and perform additional responsibilities as required.

Requirements

~2 min read

Bachelor's degree, preferably in a scientific, statistical, mathematical, or related discipline. Equivalent combinations of education and relevant professional experience will also be considered.
Extensive hands-on experience in statistical programming using SAS or other relevant programming software, preferably within clinical trials or the pharmaceutical industry.
Strong knowledge of clinical trial data, statistical programming methodologies, and the development of clinical study outputs.
Experience developing, validating, and reviewing complex datasets, tables, listings, and figures in accordance with statistical and sponsor requirements.
Previous experience leading statistical programming activities, coordinating project deliverables, or providing technical guidance to other programmers.
Familiarity with clinical study documentation, including SAPs, annotated CRFs, mock shells, and programming specifications.
Good understanding of clinical research quality standards, regulatory requirements, SOPs, and ICH guidelines.
Strong analytical, problem-solving, and troubleshooting abilities, with excellent attention to detail.
Excellent written and verbal communication skills, with the ability to collaborate effectively with multidisciplinary and international teams.
Strong organizational and time-management skills, including the ability to manage multiple projects, competing deadlines, and changing priorities.
Professional fluency in English, including the ability to read, write, speak, and understand technical and project-related documentation.
A proactive, collaborative mindset, with the ability to mentor colleagues, contribute to team discussions, and independently drive assigned activities to completion.
Willingness to undertake occasional business travel when required.