Manager, Statistical Programming

Accountabilities • Independently develop, validate, maintain, and quality-check SAS and R programs supporting clinical studies and regulatory submissions.

• Develop and validate SDTM and ADaM datasets in accordance with CDISC standards, study specifications, and project requirements.

• Program, generate, review, and validate efficacy and safety Tables, Listings, and Figures (TFLs) based on statistical analysis plans, mock shells, and internal standards.

• Support programming deliverables across multiple studies and projects while maintaining high standards of quality and timeliness.

• Collaborate with Biostatistics, Data Management, Clinical, and other cross-functional teams to resolve data issues and support study objectives.

• Participate in code reviews, debugging, validation, and quality-control activities, including reviewing and validating code developed by other team members.

• Contribute to programming documentation, dataset specifications, standard processes, and reusable programming assets such as macros and templates.

• Identify opportunities for process improvement, standardization, and increased programming efficiency.

• Provide technical guidance and day-to-day support to junior programmers and peers when needed.

• Maintain consistent delivery of high-quality programming outputs within a fast-paced clinical development environment.

Requirements

• Bachelor’s or Master’s degree in Data Science, Statistics, Computational Biology, Bioinformatics, Computer Science, or a related discipline.

• 7+ years of relevant industry experience in clinical statistics or statistical programming, preferably within pharmaceuticals, biotechnology, or CRO environments.

• Strong hands-on experience with SAS programming and demonstrated expertise in CDISC-compliant statistical programming.

• Strong knowledge of CDISC standards, particularly SDTMIG and ADaMIG.

• Demonstrated experience developing efficacy and safety TFLs for clinical study reports and/or regulatory submissions.

• Solid understanding of clinical trial design, clinical data structures, data analysis, statistical reporting, and regulatory requirements.

• Experience with R programming and the ability to work across SAS and R environments.

• Strong problem-solving, analytical, organizational, communication, and attention-to-detail skills.

• Ability to work independently, manage multiple priorities, and consistently meet project deadlines.

• Comfortable working across multiple phases of clinical development and adapting quickly to changing priorities.

• Experience working with international teams in a remote environment is a plus.

• A strong statistical background or knowledge is an advantage.

• Experience with submission-related deliverables such as Define.xml, SDRG, ADRG, P21 reports, or similar documentation is a plus.

• Experience supporting Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE) is a plus.

Benefits

• Competitive overall compensation package.

• Comprehensive benefits designed to support a range of employee needs.

• Access to benefits that may include employer-sponsored programs alongside employee contribution options.

• Remote working opportunity within India.

• Full-time employment.

• Benefits and specific offerings may vary depending on location, role, and business unit.

• Opportunity to work on clinical development and regulatory submission activities within a global environment.

• Collaborative, cross-functional working environment with opportunities to contribute to process improvement and programming standards.

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