Biostatistician

Responsibilities

• Develop analysis plans, table shells, programming and table specifications; produce tables, listings and figures; perform data review and statistical analysis.
• Assist with protocol development, sample size calculation, protocol and case report form (CRF) review.
• Advise data management staff on database design and critical data. May advise on validation checks.
• Write statistical sections of integrated reports.
• Under supervision, act as statistical team lead for single studies.
• Understand the Scope of Work, budget and quote assumptions, estimate the work completed, and manage the scope for single studies. May manage project budget and resource requirements and provide revenue and resource forecasts for single studies.
• Assist with review of RFPs and QIPs; prepare proposal text. May participate in bid defence meetings.
• Provide training and guidance to the lower level and new staff.

Requirements

• Excellent attention and accuracy with details.
• 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
• Working knowledge of relevant Data Standards (such as CDISC/ADaM)
• Familiarity with other relevant statistical computing packages such as StatXact