Manager, Statistical Programming
About the role
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.
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.
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.
Requirements
Benefits