Director, Statistical Programming
Current-Work with Project Managers and programming Team Leads in the resource planning, allocation, and assignment of programmers. Address resourcing to adequately staff projects as needed.-Lead and contribute to departmental process and standards initiatives such as macro tools, innovation, CDISC standards implementation.-Provide managerial support to the employees with overall responsibility of leading, training, and mentoring for effective performance.-Provide timeline and resource forecasts for statistical programming deliverables, ensure quality and timely delivery.-Act as technical resource for programming group to provide advice on complex programming tasks and/or standards as needed.-Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.-Perform Technology due diligence and work with IT department to deploy the tools like SAS E-Guide & R; Involve in IQ OQ PQ testing during SAS implementation on UNIX server.-Work with Business Development, QA and Finance departments in the process of scaling up the organization for prospect new clients; Develop the interview processes, hiring, onboarding, custom training plans as per the business needs.-Collaborating with internal team members effectively to help develop/enhance/maintain global macros and processes.-Oversee Programming support for relevant deliverables, such as regulatory submissions, including CDISC compliant datasets (SDTM, ADaM), data documentation (Define.xml), Reviewer’s Guide (SDRG, ADRG), TLFs, Statistical Analysis Plans (study specific, ISS, ISE), CRF reviews.-Lead Programming activities through various deliverables including sNDA, DMC, and RMP deliverables.-Program analysis datasets, statistical tables, figures, listings, ISS, ISE, DSUR, PSUR, IB, progress reports, electronic submissions, and other internal and external requests (e.g., publications, responses to regulatory questions).
