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)
Provide advanced technical expertise to develop and maintain programs to meet internal and external clients needs. Plan and lead the development of project-related solutions to the full scope of statistical programming tasks. Provide technical expertise to the Statistical Programming department.
Perform and plan: (i) the programming, testing, and documentation of programs for use in creating statistical tables, figures and listing, (ii) the programming of analysis dataset (derived datasets) and transfer files for internal and external clients. and (iii) the programming quality control checks for the source data and report the data issues periodically.
Detect errors in detail,them corrects (e.g., reviews tables/listings, edit checks output and SAS programs to ensure quality of deliverable) and report it to appropriate personals (internal or external clients)
Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department.
implementation Perform and plan the development, and validation of new process technologies, macros and applications.
Fulfill project responsibilities at the level of technical team lead for single studies, under supervision.
Understand timelines for and milestones affecting their work and alert supervisor to potential slippage.
Provide training and mentoring to SP team members.
Knowledge of statistics, programming and/or clinical drug development process
In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Ability to implement programming specifications, as appropriate
Ability to estimate programming scope of work and assist in communicating project status
Working knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
Exhibits routine and occasionally complex problem solving skills
Recognizes when negotiating skills are needed and seeks assistance.
Good organizational, interpersonal, leadership and communication skills
Ability to effectively handle multiple tasks and projects, under supervision
Excellent accuracy and attention to detail
Ability to establish and maintain effective working relationships with coworkers, managers and clients.