Regulatory SubmissionsStatistical Programming and AnalysisBiostatisticsProject LeadershipQuality AssuranceCDISC ExpertiseMentorship and TrainingInnovation and Process Improvement

Clients RelationsLeadershipBusiness DevelopmentInnovations ManagementProject ManagementTeams ManagementSalesDepartment Head

• All the Responsibilities from AD position• Project Management and Budgeting• Resourced Distribution• Business Development• Bid Defense• Business Relationships• Providing services for the Clients

• Line manager for various levels of Statistical Programmers.• Development and providing expertise of specifications, aCRF, data reviewer’s guides, define.xml document.• Performing Senior review for whole studies and partial tasks.• Develop programs and macros for SDTM\ADaM\TLFs for production or validation sides.• eCRF validation and harmonization with study protocol and statistical methods• Creation and implementation the study plan for Statistical Programmers.• Derived data validation and optimization with Pinnacle 21 .• Reconciliation the external LB and PK data to match with clinical data captured by EDC.• Leading programming activities on studies including SAP and TLF shells review and annotation. • Randomization scheme creation and providing a support.• Lead programmer's role and deliveries management.

• SDTM• ADaM• TLFs• Project Management• Line Management• Lead Programmer Role

• Spec Writing\aCRF\CDISC Report\Define.xml\Reviwers Guide• New Teams Education• Manager's Responsibilities

• SAS Programming and Environment Support

• Team Leading and consolidation with other departments• Creation an additional software for the automation• Provision various forms of SQL reports from huge 1TB database to superiors• Administration and support of data replication system for more than 700 databases

• Administration and management of large sized databases• Firebird, SQL, Delphi, Citrix Virtualization and MS Access use

• Testing the specialized software implemented on the client-server architecture serviced by RDBMS Firebird

• Provide technical support to end users via remote access