Biostatistician II

When our values align, there's no limit to what we can achieve.
 

Experience in anyone of below mentioned field

Hematology (HEM) Cell Therapy (CMC regulatory Submission) Cardiovascular (CV) \ Neuroscience (NS)

Key Responsibilities:

 Independently leads the development and execution of statistical aspects for studies of low to moderate complexity.

 Participates in PRC reviews of study protocols and SAPs.

 Provide data interpretation for study documents, e.g. CSR.

 Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product.

 Develops trial designs that address study objectives that will support regulatory approval and market access.

 Translates scientific questions into statistical terms and statistical concepts into layman terms.

 Communicates effectively with clinical and regulatory partners and external opinion leaders.

 Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents.

 Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted.

 Drives alignment at study team level and escalates lack of team alignment to the GBDS Lead for resolution.

 Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions.

 Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.

 Keeps up-to-date with state-of-the art applied statistical methodology.

 Understanding of CDISC standards and implementation guides.

Skills, Knowledge, and Experience:

Minimum Requirements:

 Master's degree in Statistics or equivalent & ≥ 3 years of industry related experience.

Or

 Ph.D. in Statistics or equivalent & ≥ 1 years of industry related experience.

Preferred Requirements: Must Have

 Ability to work successfully within a global cross-functional teams leading to successful regulatory filings and approvals.

 Excellent verbal and written communications skills.

 Ability to be flexible and adapt quickly to the changing needs of the organization.

 Ability to organize multiple work assignments and establish priorities.

 Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.

Project Statistician Specifics

 Demonstrated knowledge of statistical / clinical trials methodology as it relates to clinical development.

 Relevant prior data analysis planning, execution and delivery experience.

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