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Purpose:

Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. Provide training, guidance and mentorship to lower level and new staff.

Responsibilities:

• 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.

• Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements.

• Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings.

• Manage customer relationships.

• Provide training and guidance to lower level and new staff.

Required Knowledge, Skills and Abilities:

• 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

• 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 nQuery

• Strong commitment to quality

• Ability to effectively manage multiple tasks and projects

• Ability to lead and co-ordinate small teams

• 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)