-17 years of industry experience on all aspects of clinical programming using SAS, including 9 years of project management.-Lead the hiring, headcount management, line management, career development and succession planning of overall statistical programming group.-Oversee the work of internal, contracting, onshore and offshore programmers; provide guidance, and mentoring programmers in statistical programming methodologies.-Involve in the development of departmental initiatives, Software and technology lifecycle planning, due diligence and validation.-Extensive experience in managing Portfolio (TA) and Program (Molecule) level activities.-Discuss the broader project plan with clinical team and with agreement from all stake holders, develop the delivery plan.-Experience in leading all programming activities through NDA approval, agency requests, and FDA inspections.-Excellent knowledge on the drug development process with strong experience in analysis, reporting and validation of all Phases (I-IV) of clinical trial data and good programming efforts for the preparation of electronic submissions for FDA.-Excellent knowledge and understanding of Code of Federal Regulations (21 CFR Part 11), ICH, GCP guidelines and CDISC standards.-Experience in providing programming support to various regulatory requests from the ageincies like FDA, PMDA, EMA, Health Canada etc.-Provide statistical programming and validation support for clinical study reports, oversee external vendors (CROs), and coordinate programming activities with the Biometrics lead and other study programmers to meet timelines.-Hands-on experience with Integrated Summaries of Efficacy (ISS) & Integrated Summaries of Safety (ISS) reporting; RTOR process; Submission related processes like SDRG, ADRG, P21, Define.xml.-Quality issue management along with root cause investigation and CAPA implementation.-Ability to work independently as well as in a team with excellent interpersonal, analytical, problem solving and communication skills.-Capable of adopting new domains, technologies, concepts and environments.
Listed skills include Sas, Sas Programming, Data Warehousing, Cdisc, and 26 others.