Biostatistician I
India, Remote 求人ID R0000024208 Category Biostatistics JobsAbout this Role
The Biostatistician I is a member of cross-functional development teams and contributes (with supervision) to activities that may include development of the statistical methods section of clinical protocols, development of Statistical Analysis and/or Data Presentation Plans, statistical data review, statistical analysis and interpretation. Also contributes to the development of clinical study/integrated reports, regulatory responses and scientific publications (including abstracts and congresses).
Biostatisticians I's are individual contributors and report to a Global Biometrics & Data Sciences (GBDS) Functional Lead; must be able to work in an environment with supervisory oversight and show willingness to learn and adapt to changing study needs in support of broader team deliveries.
Key Responsibilities:
Performs preplanned statistical analyses, e.g. from the SAP or DPP, with supervision.
Presents analysis results and interpretations to GBDS team.
Provides internal GBDS review of other SAPs, results, CSRs.
Knowledge of results outside of traditional statistical expertise in the clinical, regulatory and commercial environments and the impact the development team.
Engages as a GBDS team member to learn the drug development process.
Assists in development of presentations of analyses to key stakeholders.
Knowledgeable of statistical methodology and how it might be appropriately applied in trial design and data analysis for clear, concise, high-quality results.
Knowledge of statistical / clinical trials methodology as it relates to clinical development.
Understanding of data analysis planning, execution and delivery.
Understanding of CDISC standards and implementation guides.
Skills, Knowledge, and Experience:
Minimum Requirements:
BS degree in Statistics or equivalent & ≥ 3 years of industry related experience.
Or
Master's degree in Statistics or equivalent & ≥ 1 year 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.
Strong 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.
Good interpersonal skills with peers and adjacent functions (e.g. statistical programming).
Biostat Specifics (Preferred)
Working 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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