Soumya Gouru

• Followed classroom plans left by class teacher to continue student education and reinforce core concepts.
• Upheld classroom routines to support student environments and maintain consistent schedules.
• Developed strong rapport with students through consistent encouragement and support, fostering a positive learning atmosphere conducive to academic growth.
• Kept students on-task with proactive behavior modification and positive reinforcement strategies.
• Enhanced classroom management by implementing positive reinforcement strategies and maintaining clear expectations for behavior.
• Served as a long-term substitute teacher, independently developed and implemented lesson plans, facilitated parent-teacher conferences, and actively participated in Individualized Education Program (IEP) meetings to support student learning and achievement.

· Have excellent experience in analyzing safety and efficacy data for phases I-III clinical trials.

· Data mapping according to CDISC standards for SDTM and ADaM data sets by using different Mapping Techniques like, merging, concatenating.

· Ability to write common local SAS macros that are useful across multiple studies for generic coding and reusable modules.

· Experience in debugging and testing SAS programs to check the data and generate reports (TFLs).

· Have capability to develop new SAS programs and/or enhancing existing SAS programs from protocols and SAP’s for creating TFLs by using SDTM and ADaM datasets.

· Have excellent command in Windows and UNIX/LINUX operating systems.

· Strong experience in coding using SQL, SAS Procedures/Functions, and SAS macros.

· Experienced on data edit checks to analyze the data and commanding experience in reviewing the CRF’s and SDTM/ADaM mapping specifications to ensure that the project standards are maintained.

· Perform Validation by using different validation methods according to given specifications to ensure the data quality.

· Exposure to CDISC Standards, Pinnacle 21 E/C, internal submissions (CSR, Interim Analysis), ISS and ISE reports, presentations (ASCO, CROI) and Regulatory submissions (FDA, EMA, PMDA, and sNDA).

· Have work experience on Ad-Hoc requests during the study submission and provided programming support to the projects/teams.

· Have knowledge on survival data analysis for Oncology trials using PROC LIFETEST to analyze the trials endpoint such as Overall Response Rate (ORR), Overall Survival (OS), Progression Free Survival (PFS) and Time to Progression (TTP).

· Knowledgeable in Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and iRECIST for immunotherapy studies.

· Efficient in maintaining working relationships with clients and internal project members, including clinical data managers, medical writers, clinical programmers, and other statistical programmers.

· Have strong ability to adapt and learn new technologies.

· Excellent organizational teamwork, presentation, problem solving, decision making and interpersonal skills.

• Assisted the leading teacher, implementing individualized education plans (IEPs).
• Provided support during instructional activities ensuring that the learning environment is accessible and tailored to each child’s unique needs.
• Helping and supervising students activities indoors and outdoors, ensuring the safety and well-being of the children.
• Behavior observation and intervention, providing feedback to the lead teacher and participating in the development of individualized learning goals.
• Foster a positive and inclusive environment, where all the students regardless of their abilities feel welcome and valued.
• Team work with the lead teacher and other members of the special education team, speech therapists, to create a supportive and nurturing learning environment for all the students.
• Flexible and managed diverse classrooms effectively whenever there was a requirement in other classrooms other than allotted.
• Experience in managing the classroom during the absence of the lead teacher.

• Assisted in delivering lectures, creating instructional materials, and conducting
laboratory sessions for post graduate biochemistry courses.
• Provided guidance and mentorship to students, answered questions, and facilitated
discussions to enhance learning.
• Graded assignments, exams, and lab reports, providing constructive feedback to help
students improve.
• Collaborated with professors to develop course curriculum and improve teaching
methods.
• Engaged students with interactive discussions, case studies, and real-world
applications of biochemistry concepts.
• Received positive feedback from students and professors for teaching effectiveness.
• Taught diverse student population by employing various learning styles and abilities.
Developed semester outlines and instructional plans for each class session to comply
with stated course objectives.
• Created materials and exercises to illustrate application of course concepts.
• Created syllabus and instructional plans for each class session in accord with stated
course objectives.
• Graded quizzes, tests, homework, and projects to provide students with timely academic progress information and feedback.
• Graded tests and assignments and uploaded to college database.
• Created positive and safe learning environment for students by setting and enforcing
classroom code of conduct.
• Met with students to dispense study and career advice and provide guidance and potential opportunities within chosen field.
• Conducted on-going program assessment, enrollment and retention tracking.
• Supported multidisciplinary research teams focused on scholarly publication.