Job Title : Statistical Programmer

Job Description:
The Statistical Programmer will lead statistical programming activities for clinical development projects, compounds, indications, or therapeutic areas. The role involves programming and validating ADaM datasets, Tables, Listings, and Figures (TFLs) using SAS and R, ensuring compliance with CDISC standards and supporting regulatory filings. The role also includes leading statistical programming teams, resource planning, ensuring timely and high-quality deliverables, developing standard SAS macros, preparing regulatory documentation, and collaborating with cross-functional teams including Statisticians, Clinical Data Management, Medical Writing, Regulatory Publishing, and Clinical Operations.

Key Responsibilities:

• Lead statistical programming activities for assigned compounds or indications.

• Lead a team of Statistical Programmers and manage resource planning.

• Ensure timely delivery and adherence to quality processes across projects.

• Develop and oversee SAS programs for ADaM datasets in accordance with CDISC standards.

• Develop and oversee SAS programs for Tables, Listings, and Figures.

• Ensure consistency of ADaM datasets across individual studies and integrated data.

• Create documentation required for regulatory filings, including reviewer guides and data definition documents.

• Lead the development of standard SAS macros and contribute to standard operating procedures.

• Provide oversight, mentoring, and guidance to Statistical Programmers, Statistical Analysts, and Senior Statistical Analysts.

• Support statistical analyses and clinical study programming activities.

• Collaborate effectively with cross-functional teams and stakeholders.

• Estimate effort required for project-related programming activities.

• Adapt to changing priorities and project deadlines.

Required Skills:

• Strong proficiency in SAS programming; experience with R is an advantage.

• Experience programming and validating ADaM, TFLs, and statistical analyses.

• In-depth knowledge of SAS programming concepts within drug development and the clinical study lifecycle.

• Strong understanding of CDISC standards.

• Knowledge of therapeutic areas such as Oncology, Immunology, Neuroscience, etc.

• Experience with regulatory filings.

• Team leadership and resource-planning skills.

• Strong written and verbal communication skills.

• Ability to work collaboratively in cross-functional teams.

• Ability to accurately estimate programming effort and manage deadlines.

Educational Qualification:

• Graduation is compulsory.

• Preferred: Life Science, Computer Science, or Statistics graduate.

Experience:

• Minimum 2+ years of experience in SAS programming.

• Experience leading statistical programmers for a compound, indication, or therapeutic area is preferred.

Important Eligibility:

• Former TCS employees / TCS rehires are not eligible.

• Graduation is mandatory.

• PAN and DOB are required to create an employee profile in the database.

• Profiles should be accompanied by a percentage match score indicating how closely the candidate profile aligns with this role.