Biostatistician I

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.