QuintilesIMS Statistical Programming Scientist in Cambridge, Massachusetts
Provide experienced, comprehensive, and advanced technical expertise as part of the Statistical Programming (SP) team to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical analysis needs. Provide advanced technical expertise to the Statistical Programming department. Provide internal consulting services, including specifications and user needs analysis for complex project, client requirements or the implementation of new technologies. Perform the role of Lead on groups of studies or integrated summaries.
Ability to effectively manage multiple tasks and projects
Excellent accuracy and attention to detail
Exhibits routine and occasionally complex problem solving skills
Recognizes when negotiating skills are needed and action accordingly.
Effectively lead teams and portfolio projects
Ability to effectively delegate work
Ability to effectively motivate other staff members
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Ability to effectively negotiate project level timelines with clients
Plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical 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..
Develop, plan, and co-ordinate programming documentation including programming plans and specifications, as appropriate, for complex studies and groups of studies.
Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and the Statistical Programming department, for complex studies. Lead committees to facilitate these technical tasks, as appropriate.
Provide expert review of process and methodology development work with regard to SP standards and validation procedures.
Fulfill project responsibilities at the level of Project Lead for group of studies or integrated summaries.
Use and promote the use of established standards, SOP and best practices
Manage project budget and resource requirements: understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage Out of Scope and provide revenue and resource forecasts for groups of studies.
Perform internal training, orientate and induct new staff, and perform role of mentor.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Statistical programming in SAS within the CRO/Pharmaceutical/Biotechnology/Healthcare industries
Experience as Project Lead directly engaging clients and coordinating tasks within a programming team
In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Knowledge of statistics and/or clinical drug development process (Phase I – IV)
Advanced knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
Knowledge of electronic submissions (including: knowledge of data submission structures and requirements; experience in creating relevant hyperlinks, etc)
Very good organizational, interpersonal, leadership and communication skills
Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Masters degree in computer science or related field and 5 years relevant experience; Bachelor's degree in computer science or related field and 7 years relevant experience; or equivalent combination of education, training and experience.
EEO Minorities/Females/Protected Veterans/Disabled