Senior Statistical Analyst

Senior Statistical Analyst

Location:

Cincinnati, OH or Chicago, IL or NYC or NJ

Job Type: Fulltime

Salary Range: $120, a year

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

Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP)

Implement Statistical Analysis Plans (SAP) and SPP to create ADaM data specifications

Program and validate ADaM and statistical analyses using programming languages (e.g., SAS, R), ensuring adherence to established standards and guidelines

Generate tables, listings, and figures (TLFs) for clinical study reports, safety reports, and other deliverables, ensuring accuracy, consistency, and adherence to regulatory requirements

Develop and maintain programming documentation, such as annotated program code, programming specifications, and validation plans

Perform quality control checks on statistical programming deliverables to ensure accuracy, consistency, and adherence to programming standards

Collaborate with cross-functional teams to support ad hoc data analyses, data visualization, and exploratory analyses as needed

Ability to lead the development and implementation of standard programming macros, utilities, and tools to improve efficiency and consistency in programming tasks

Stay updated with industry best practices, regulatory guidelines, and emerging technologies in statistical programming and data analysis

Lead the planning and execution of statistical programming-related audits, inspections, and regulatory submissions, ensuring compliance with relevant regulations and guidelines

Collaborate with statisticians and study teams to provide programming support, address data-related queries, and contribute to study-related publications

Performs assigned task(s) in accordance with customer requirements within agreed timelines and Quality

Escalates unresolved issues appropriately to Team Lead /Project Lead

Tracks and follows up on all issues raised

Provides timely status updates

Proactively highlight risk

Coach/Mentor/Train new team members and line function as per requirement

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.