Senior Statistical Analyst

Greetings !!!

• Role: Senior Statistical Analyst
• Location: Cincinnati, OH
• Duration: Full time

Job Description:

• Required Skillsets:
• Proficiency in SAS / R programming languages to Program and validate ADaM, TFL and statistical analyses
• Proficiency in using statistical software and programming tools
• Understanding of statistical methods, data analysis techniques, and clinical research processes.
• Advance knowledge of CDISC standards and therapeutic area (Oncology, Immunology, Neuroscience etc.)
• Strong attention to detail and quality Focus
• Problem-solving skills (Ability to identify and troubleshoot programming issues)
• Effective communication skills (both written and verbal)
• Ability to interact professionally with statisticians, study teams, and external partners
• Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines.

Key Responsibilities:

• 1. Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP). Implement Statistical Analysis Plans (SAP) and SPP to create ADaM data specifications.
• 2. Program and validate ADaM and statistical analyses using programming languages (e.g., SAS, R), ensuring adherence to established standards and guidelines.
• 3. Generate tables, listings, and figures (TLFs) for clinical study reports, safety reports, and other deliverables, ensuring accuracy, consistency, and adherence to regulatory requirements.
• 4. Develop and maintain programming documentation, such as annotated program code, programming specifications, and validation plans.
• 5. Perform quality control checks on statistical programming deliverables to ensure accuracy, consistency, and adherence to programming standards.
• 6. Collaborate with cross-functional teams to support ad hoc data analyses, data visualization, and exploratory analyses as needed.
• 7. Ability to lead the development and implementation of standard programming macros, utilities, and tools to improve efficiency and consistency in programming tasks.
• 8. Stay updated with industry best practices, regulatory guidelines, and emerging technologies in statistical programming and data analysis.
• 9. Lead the planning and execution of statistical programming-related audits, inspections, and regulatory submissions, ensuring compliance with relevant regulations and guidelines.
• 10. Collaborate with statisticians and study teams to provide programming support, address data-related queries, and contribute to study-related publications.
• 11. Performs assigned task(s) in accordance with customer requirements within agreed timelines and Quality.
• 12. Escalates unresolved issues appropriately to Team Lead /Project Lead. Tracks and follows up on all issues raised. Provides timely status updates. Proactively highlight risk.
• 13. Coach/Mentor/Train new team members and line function as per requirement.

• Role: Lead Statistical Analyst
• Location: Cincinnati, OH
• Duration: Full time

Job Description:

• Required Skillsets:
• • Experience in leading a team of statistical programmers for a compound/indication or therapeutic area
• • Proficiency in SAS / R programming languages to Program and validate ADaM , TFL and statistical analyses
• • In-depth understanding of SAS programming concepts and techniques in drug development process and clinical study life cycle
• • Good to have experience in other statistical programming languages (R).
• • In-depth understanding of CDISC standards and therapeutic area (Oncology, Immunology , Neuroscience Etc.)
• • Experience with regulatory filings.
• • Effective communication skills (both written and verbal)
• • Ability to effectively represent the Statistical Programming Organization in cross functional teams (Statisticians, Clinical Data Management, Medical Writing, Regulatory Publishing and Clinical Operations).
• • Ability to accurately estimate effort required for project related programming activities.
• • Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines

Key Responsibilities:

• 1. Leads the statistical programming activities for a compound/inidication.
• 2. Leads a team of statistical programmers and manages the resource planning for assigned staff.
• 3. Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
• 4. Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
• 5. Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
• 6. Ensures consistency of ADaM data sets for individual studies and integrated data.
• 7. Creates documentation for regulatory filings including reviewers guides and data definition documents.
• 8. Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
• 9. Provides oversight and mentoring of assigned Statistical Programmers, Statistical Analysts and Senior Statistical Analysts.

• Suneetha K
• Team Lead
• Email: [email protected]
• 6096590999 Ext 322