Sreedevi Pulipaka Email and Phone Number
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As an Associate Director of Statistical Programming at Arcutis Biotherapeutics, Inc., I lead the programming and quality control activities of phase II and III studies for innovative dermatological treatments. With more than eighteen years of experience in the pharmaceutical industry, I have developed and validated analysis datasets, tables, figures, and listings, following company standards and regulatory guidelines. I have extensive experience in the CDISC SDTM and ADaM standards, ISS and ISE analysis, P21 validation and development and review of Reviewers guide. I have also contributed to the successful submission of many phase III studies to the FDA, PMDA and other regulatory agencies providing the required documents and files for the electronic submission. I have worked in many TAs including Oncology, CNS, Infectious diseases, Dermatology, Ophthalmology, Cardiovascular.In addition to my technical skills, I have also demonstrated my leadership and collaboration abilities by managing and mentoring a team of programmers, coordinating timelines and milestones, and providing training and support for the department applications and tools. I am passionate about applying my mathematical and computational background to the field of clinical research, and I am always eager to learn new methods and technologies to enhance the quality and efficiency of the statistical analysis. My goal is to deliver reliable and robust results that can support the development and approval of new therapies for patients with unmet medical needs.
Truminds Clinical
View- Website:
- trumindstech.com
- Employees:
- 31
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Truminds ClinicalBridgewater, Nj, Us -
Programming ConsultantInfocus Clinical Research Jan 2024 - Aug 2024Nashville, Tn, UsEstablished the process and trained creating the define files for the SDTM and ADaM data. Created macros for Define process, created validation checks. Created the CDISC mapping specifications for the SDTM and ADaM datasets. Created and validated SDTM, ADaM and TLFs. Reviewed the final TLFs for consistency checks. -
Associate Director Of Statistical ProgrammingArcutis Biotherapeutics, Inc. (Nasdaq: Arqt) Jan 2022 - Oct 2023Westlake Village, California, Us -
Senior Principal Statistical ProgrammerShionogi Inc. Feb 2017 - Dec 2021Florham Park, New Jersey, Us -
Pr. Statistical ProgrammerEverest Clinical Research Oct 2016 - Dec 2016Toronto, Ontario, Ca -
Programming Consultant At GskGsk Oct 2014 - Sep 2016Brentford, Middlesex, GbShall provide statistical programming expertise (preferably in SAS) in the production of analyses, tabulations, graphics, and listings from clinical trial data. Key responsibilities and skills include, but are not limited to, the following: Contribute to the preparation of analysis plans. Prepare, document and test required programs and procedure data displays in an efficient manner for inclusion in integrated clinical. statistical reports and other similar reports. Contribute to the integrated clinical/statistical report and other similar documents. Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting. Perform quality assurance procedures on work performed by others. Develop, test, validate, document, maintain and execute software and/or systems using the currently endorsed tools or support of production activities. Assist in the integration of data from remote entry sites. -
Sr. Manager Statistical ProgrammingSunovion Pharmaceuticals Inc. Jan 2014 - Oct 2014Marlborough, Ma, Us -
Lead ProgrammerRegeneron Pharmaceuticals, Inc. Jan 2010 - Jan 2014Tarrytown, New York, Us• Support and lead programmer for programming and QC of analysis datasets, TFLs or standard tools following Regeneron standard data models or user requirements. Assist in the coordination of activities and communicate shifting timelines and milestones. Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies. Support creation and validation of submission requirements (i.e. annotated CRF, data export files, define documents).Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. If applicable, develop and provide department training for applications and standard tools developed by the department functions group. Provide programming support for simple presentations and basic statistical ad-hoc requests. Assist in the more complex data presentations. Participate in department working groups; provide input in development of tools and improvement of processes. -
Sr. Statistical Programmer ConsultantGsk Nov 2007 - Dec 2009Brentford, Middlesex, GbLead programmer for a Phase I Oncology study. Level 3 validation support for key efficacy analysis for a Phase III Oncology study, Supported the programming efforts for the VOTRIENT submission. Supported statistical programming group in deriving the analysis datasets, TFLs and daily adhoc reports. Oncology and Cardio Vascular therapeutic experiance. -
Statistical Programmer ConsultantCentocor Nov 2006 - Nov 2007UsSupported programming team in creating/validatiing the clinical data. Programming support to clean the data, producing statistical reports, macros to support the statistical analysis. Worked on the REMICADE for psoriatic arthritis therapy. -
Sas/Statistical ProgrammerOctagon Research Solutions Aug 2005 - Nov 2006Programming support in standardizing the CDISC SDTM post ETL data. Modified/created Edit checks for the SDTM mappings, dropping Null Permissible variables, format catalogue checks.
Sreedevi Pulipaka Skills
Sreedevi Pulipaka Education Details
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Ohio UniversityMathematics With Computational Track -
Andhra UniversityInformational Technology -
Andhra UniversityStatistics
Frequently Asked Questions about Sreedevi Pulipaka
What company does Sreedevi Pulipaka work for?
Sreedevi Pulipaka works for Truminds Clinical
What is Sreedevi Pulipaka's role at the current company?
Sreedevi Pulipaka's current role is Associate Director of statistical programming.
What is Sreedevi Pulipaka's email address?
Sreedevi Pulipaka's email address is sr****@****ion.com
What schools did Sreedevi Pulipaka attend?
Sreedevi Pulipaka attended Ohio University, Andhra University, Andhra University.
What skills is Sreedevi Pulipaka known for?
Sreedevi Pulipaka has skills like Statistical Programming, Cdisc, Validation, Oncology, Pharmaceuticals, Ophthalmology, Macros, Adam.
Who are Sreedevi Pulipaka's colleagues?
Sreedevi Pulipaka's colleagues are Harika Krishna, Srikanth M, Ahmed Arshad, Alison Martin, Gopi Katru, Nathan Adelson, Jyothi Parthi.
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