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 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 defense meetings.
Provide training and guidance to lower level and new staff.
Excellent written and oral communication skills including grammatical/technical writing skills
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
Strong individual initiative
Strong organizing skills
Strong working knowledge of SAS computing package
Familiarity with other relevant statistical computing packages such as StatXact
Strong commitment to quality
Ability to effectively manage multiple tasks and projects
Ability to provide and accept direction of lead team members
Ability to solve moderately complex problems
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Working knowledge of relevant Data Standards (such as CDISC/ADaM)