Biostatistician - Pharma

JOB DESCRIPTION -

OVERVIEW

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. Biostatisticians will also work on statistical programming for development of analysis datasets, and clinical tables, listings, and graphs specific to trial reporting requirements. Biostatisticians will work as needed assuring that all client work has met or exceeded client expectations.

This position reports to Management representative of the Professional Services Team.

KEY TASKS & RESPONSIBILITIES

- 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.