Principal Biostatistician

OVERVIEW

The Principals Biostatisticians will work closely with clients and provide high level consulting services for statistical analysis, reporting, and statistical programming specific activities which may include development of statistics section of protocol, development of statistical analysis plan, randomization schedule, conducting statistical analyses, validating programming and reporting output, and developing statistical analysis report. Principal Biostatisticians will also work on statistical programming for development of analysis datasets, and clinical tables, listings, and graphs specific to trial reporting requirements. Principal Biostatisticians will work as needed assuring that all client work has met or exceeded client expectations.

Your day to day:

• Provide consulting of statistics activities related to clinical trials. Fulfill the responsibilities of study statistician as required
• Provide mentoring and QC of statistical programmer’s outputs; define analysis data specifications. If required, validate the statistical models used for programming
• Act as study statistician - interact with client and with clinical team including programmers, clinical data managers, clinical protocol manager, and other relevant personnel. Ensure that programmers get correct specifications and data at appropriate time
• Develop, review, and finalize the statistical analysis plan
• Validate the programming deliverables and collaborate with applicable team members to rectify any issues related to statistical reporting and analysis
• Develop randomization schedule, specifications, and guidelines
• Wherever applicable, provide input in finalization of study specific data quality control plan and ensure appropriate data analysis and reporting
• Wherever applicable, develop, validate and finalize the study specific list of table and table shells for clinical study reports and for study specific deliverables
• Ensure that all comments from the clinical team with regards to statistical report delivered for study specific deliverables are being addressed appropriately
• Analyze the data and contribute to trial progression related decisions by providing necessary input during trial specific deliverables including but not limited to blinded data reviews, and interim analyses
• Collaborate with team members for regulatory reviews, representations, and supporting data analyses including the study or compound level exploratory analyses, ad-hoc analyses, and post-hoc analyses
• Develop SAS programs to generate analysis datasets, and trial specific reporting including but not limited to tables, listings, graphs, queries, and patient profile reports
• Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures
• Other duties as assigned

Qualifications:

• Master in Statistics or biostatistics preferred
• SAS® certification is preferred
• 10+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role preferred
• Strong experience with clinical study design development, analysis, and sample size determination
• Experience with development of randomization schedule including development of IVRS specifications, and guidelines for appropriate usage of randomization schedule
• Excellent knowledge of English and with clear, concise, and accurate communications, both written and verbal
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Ability and experience of delegating tasks and leading projects. Experience of working on multiple clinical protocols at the same time
• Ability to balance conflicting priorities
• Strong knowledge of ICH guidelines and other guidelines such as GCP, and 21 CFR Part 11 from different regulatory agencies including FDA, and EMEA
• Experience in developing statistical analyses reports, and in conducting statistical analyses and reporting for various trial level deliverables including but not limited to blinded data reviews, interim analyses
• Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) and clinical reporting processes
• Knowledge of CDISC® related data models such as SDTM, and ADAM. Ability to develop ADAM model for analysis and reporting of clinical trial. Through understanding of SDTM data structures

Employees are expected to appropriately leverage company-approved AI tools to improve productivity and quality while adhering to company policies, protecting confidential information, validating AI-generated content, and exercising sound professional judgment. AI is intended to augment—not replace—professional judgment, critical thinking, accountability, and decision-making. Accountability for all work remains with the employee.