Manager SAS Programmer
Experience:10 - 12 Years
Location:Bengaluru/Bangalore
Education:UG - Any Graduate - Any Specialization PG - Any PG Course - Any Specialization
Industry Type:BPO/ITES
Role:Project Mgr-IT/Software
Functional Area:Application Programming, Maintenance
Desired Candidate Profile
• 7+ years of Software lifecycle experience in Application Software Designing, Development, testing and Implementation of various Data warehousing, client server and web applications, using state of the art technologies under WINDOWS, and UNIX.
• Experienced in SAS/BASE, SAS/MACROS, and SAS/CONNECT SAS/ACCESS, SAS/ASSIST and SAS/AF in windows and UNIX environments.
• Good communication, analytical and problem solving skills.
• Good entrepreneurial and leadership and time-management skills.
• Ability to work and collaborate across multiple teams and projects.
• Knowledge of different therapeutic areas and having regulatory submission experience.
• Worked Extensively on UNIX SAS.
• Well versed with Base SAS (Windows & Unix platforms), SAS Macros, SPDS, Oracle 9i, TOAD, PL/SQL.
• Self-motivated, adaptive to new technologies, team player ability with good interpersonal and communication skills.
• Lead teams of various sizes and compositions.
• Extensive knowledge in Design, Development and Customization of SAS Scripts for Extraction, Transformation, Data Analysis and Data Modeling.
• Knowledge of new drug and device release process, which includes Clinical Trials (Phases I-III), preparation of IND, NDA, safety reviews, integrated safety and efficacy summary (ISS & ISE) for FDA submission.
• Preparing Project plan and Estimations for the projects.
• Preparing Proposals, Functional Specifications and Detailed Design documents.
• Generating decision support adhoc reports.
• Trained in Data modeling, SAS ETL Studio(DI Studio) from Satyam Computer services.
• Knowledge of DATA WAREHOUSING, DATA MARTS.
• Given basic UNIX training to the team and make sure the team is working in UNIX effectively.
Job Description
Phase III Osteoporosis Study- Safety & Efficacy reporting and creation of analysis datasets and provide inputs to RAP meetings.
Phase-I / III Muckel Well Syndromes Study- Safety & Efficacy reporting, creation of analysis datasets and provide inputs to RAP meetings.
Pooling study: Wrote programming specifications for pooled analysis datasets and led the team members with perfect co-ordination. And had a great achievement of Drug Approval in this rare Orphan disease from FDA, EMEA, and SWISSMEDIC.
Phase IV Kidney transplantation (Myfortic) Study- Led the team and worked on Safety & Efficacy reporting, creation of analysis datasets and safety reporting.
RMP (Risk Management Plan) studies - Prepared the reports on Risks related to the Skin Infections for the submission to EMEA. Worked on creation of adverse events reports and Standardized MedDRA Queries (SMQs) under guidance of Project statistician.
In addition to the projects cited above, Full validation support is given to different therapeutic areas as part of my objective due to critical submission timelines
Currently working on NSO TA: Phase III Multiple sclerosis study
Created most of the CRTs done here, and I am SME for CRT from India.
Working on Health Authority (FDA, EMA, Swiss, Australia and Canada) questions.
Responsibilities:
As a Senior Programmer, to be primarily responsible for all statistical programming activities on allocated studies including planning and coordination of activities.
Lead a complex/large project under supervision of a Program Programmer / Group Head.
Maintain efficient interfaces with internal and external customers with support of the Project Leader and the Program Statistician
Developing specifications for analysis datasets by writing Report & analysis plan document, and producing analysis datasets, pooled datasets, TLGs (Tables, Listings, Graphs) according to specifications for all phases of clinical trials and for SCS and SCE with high quality.
Reviewing programming specifications document written by CRO programmers as a part of Acceptance checks on CRO outputs.
Statistical programming for both production and QC of derived datasets, data listings, data summaries, figures and statistical appendices for global Phase I-IV trials.
Participate in non-clinical project activities such as Training to New comers, GPS – II migration.
Responsible for the quality and timeliness of statistical programming deliverables.
Train staff on trial and project level activities and internal reporting systems.
Key solution provider on technical subjects or processes, also effectively implementing solutions with a team. Guide others in independently handling issues and problem solving.
Created the CRTs for the key submission to regulatory authority, FDA and successfully developed the CRT tool by automating the CRT process.
Mentor the new team members to make them productive on work at the earliest and keep a regular track of their productivity and quality of deliverables.
Maintain records for all assigned projects including archiving of trial analysis and associated documentation.
Environment: SAS9.2: SAS/BASE, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/MACRO Windows, UNIX and Citrix.
Led team assembled to study the integrated distribution process and determine the optimal order capture, processing, fulfilment and delivery method. Resulted in 25% process efficiency improvement in month following implementation.
Keywords: SAS, SAS Macros , data warehousing , SAS testing, testing
Contact Details
Ikya Human Capital Solutions Pvt Ltd
Website:http://www.ikyaglobal.com
Executive Name:Mita
Email Address:mita@coachieveindia.com
Telephone:9910213130