Katalyst Healthcares & Life Sciences – Katalyst HLS
Position Type: Full-Time/Contract
Experience Level: 5 Years
Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis.
Perform protocol development, sample size calculation, protocol and CRF review.
Advise data management staff on database design, and critical data. May advise on validation checks.
Write statistical sections of integrated reports.
Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data).
Act as statistical team lead for single complex studies or groups of studies.
PhD in biostatistics or related field and 5 + year relevant experience.
In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Familiarity with moderately complex statistical methods that apply to applicable clinical trials.
Excellent written and oral communication skills including grammatical/technical writing skills. Excellent attention and accuracy with details.
Strong individual initiative, Strong organizing skills..
Math & Economics , Statistics , Medical & Health