- Strategic innovation development and leadership for various data and standards solutions and processes- Operational leadership and oversight- People management- Training and Development- Recruiting

Primarily function as line manager for multiple direct reports, as well as serving as SDTM Operational Oversight for multiple customers and projects (large scale 100+ studies). SDTM SME and Lead of Standards and Processes for department. Additional responsibilities include:Manage a team of Statistical Programming (SP) staff, including hiring, training, and supervising department members. Develop, recommend, and implement standard procedures, measures of performance, and training… Show more Primarily function as line manager for multiple direct reports, as well as serving as SDTM Operational Oversight for multiple customers and projects (large scale 100+ studies). SDTM SME and Lead of Standards and Processes for department. Additional responsibilities include:Manage a team of Statistical Programming (SP) staff, including hiring, training, and supervising department members. Develop, recommend, and implement standard procedures, measures of performance, and training programs. Organize and allocate resources according to multi-project requirements and deadlines. Serve as lead statistical programmer on projects.Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resource matters. Participate in project meetings; keep up-to-date on project issues; keep Director informed of project issues. Coordinate and participate in process improvements and interoffice/interdepartmental task forces; oversee collection and reporting of Stat Programming metrics, implementation of revised work practices, new guidelines, and new software tools as they become available. Effectively recommend resource allocation at the site level so as to achieve target utilization rates and project realization rates. 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, integrated summaries or eSubmissions. Assist in the following: (i) sales meetings as required; (ii) overseeing proposal preparation; (iii) ensuring that all proposals bid by the department have an adequate budget, and sufficiently detailed set of budget assumptions. Show less

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… Show more 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, corrects them (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. Perform and plan the development, implementation 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 Show less

-> Member of SDTM Centre of Excellence-> Operational Team Lead on 15+ studies-> Lead of Production Programming Group-> Member of Global Biostatistics CDISC Subject Matter Expert (SME) Group-> Member of the Employee Engagement Initiatives Group-> Senior Bio statistical Reviewer of CDISC SDTM deliverables-> Experienced in internal and external communications and relations.

SDTM Study Lead on several major oncology trials and member of the SDTM Center of Excellence

SAS programming of derived datasets and study lead of several sponsor studies.