Senior Statistical Programmer

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee statistical programming tasks across various intricate clinical studies, ensuring the delivery of datasets, analyses, and submission packages is both timely and of high quality.

• Create, validate, and review datasets compliant with CDISC standards, specifically SDTM and ADaM, along with tables, figures, and listings (TFLs) to facilitate clinical study reporting and regulatory submissions.

• Offer expert advice on specifications for clinical databases, data transfer agreements, analysis datasets, TFL shells, and submission documentation.

• Act as the programming project lead, overseeing priorities, resource allocation, study timelines, and communication with stakeholders across both internal and external teams.

• Ensure adherence to global regulatory standards and industry guidelines, including CDISC, FDA, PMDA, ICH, GDPR, and relevant quality procedures.

• Promote continuous improvement initiatives by developing programming standards, SAS macros, templates, and operational efficiencies.

• Mentor, train, and guide Statistical Programmers, Biostatisticians, Data Managers, and other stakeholders on programming processes, standards, and regulatory requirements.

• Assist during audits, inspections, proposal evaluations, budget discussions, bid defenses, and sponsor meetings as a subject matter expert in statistical programming.

⛳️ Requirements

• A degree-level education or an equivalent qualification, paired with at least 6 years of pertinent statistical programming experience.

• Proficient in advanced SAS programming, including SAS/Macro, Proc Report, ODS, Proc SQL, SAS/STAT, and other related programming tools.

• Significant experience in creating and reviewing CDISC-compliant SDTM and ADaM datasets, TFLs, and electronic submission materials.

• Proven experience in providing technical leadership and programming oversight for complex clinical studies and projects.

• Strong knowledge of regulatory submission requirements and industry standards, such as CDISC, FDA, PMDA, ICH, GDPR, and Good Clinical Practice (GCP).

• Demonstrated capability to lead projects, manage competing priorities, and collaborate effectively with sponsors and cross-functional teams.

• Exceptional analytical, problem-solving, communication, mentoring, and training abilities, with a keen eye for detail.

• Fluent in English.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible working arrangements to promote work-life balance.

• Competitive salary and performance-based incentives.