A Manager provides timely support to the study team on all programming matters according to the project strategies. As an integral part of a study team, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan, programming specification or user requirements document using internal standards and guidelines. The incumbent provides guidance in implementing and executing the programming and project standards. The incumbent will be responsible for leading the programming aspect of a project, both internally or CROs, for all programming deliverables from the single study through to regulatory approval, product launch, data monitoring boards and annual reports. Oversees documentation and ensures consistent maintenance of code, logs, and output within a regulated environment. Meets statistical adhoc requests of senior management.
Develop an expertise within a therapeutic area or standard tool. Work with minimal supervision to perform, coordinate and oversee the preparation, execution, reporting and documentation of a project.
• Function as a lead programmer in the development and QC of tables, listings, graphs, or systems in support of analysis requirements utilizing the employers tools and methodologies and current industry standards (i.e. CDISC SDTM / ADaM)
• Manage the effort, including esubmssion deliverables, using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming deliverables. Provide programming support for complex presentations and more complex statistical ad-hoc requests.
• Act as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. If applicable, lead an application development and act as the programming representative to the user audience.
• Work with management to determine resource requirements for therapeutic area or department function responsibilities.
• Review and select resumes, screen and interview candidates for contractor and permanent positions.
• Provide feedback to management regarding team member’s contributions to the work effort for evaluating individual's performance and recommend yearly goals.
Experience And Required Skills :
Advises all direct reports about the procedures surrounding retention of data, records, and information for employees in their group
Also acceptable – MS. in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 5+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry, including some project and people management experience. SAS Certification desirable.
Works independently, exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
o Advanced SAS programming skills, preferably in a clinical data environment.
o Experience in the analysis of at least one therapeutic area.
o Strong understanding of relational databases and experience working with complex data systems.
o Strong understanding of reporting systems utilizing multiple data delivery applications.
o Experience in development and implementation of standardization methodology within at least one therapeutic area.
o Collaborative teamwork and interpersonal skills that demonstrate initiative and motivation. Ability to problem solve. Excellent verbal and written communication skills in a global environment.
o Experience in pharmaceutical clinical development in at least one therapeutic area (i.e. understanding of statistical concepts, techniques and clinical trial principles within a therapeutic area) and ability to provide programming support needs for BLA and other regulatory submissions.
o Experience in project management with minimum supervision. Demonstrates ability to effectively organize and manage multiple assignments with challenging timelines across multiple personnel.
o Experience in project start-up through submission.
o Experience in the hiring, development, evaluation and support of junior staff and contractors.
o Knowledge in creation of current CDISC data structures.
SAS, (Base, Stat, Macro, graph) and S-Plus/R.
May report to a Assoc. Director or above. Requires the ability to influence others to achieve results. May manage subordinates.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry.