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We are searching for innovative thinkers to collaborate and grow in the creative technology space. Come join us to collaborate on ambitious projects in an inspirational and joyfull work enviroment. Please send your resume to hr@epda.in or upload your resume for appropriate jobs posted below.
Clinical Data Analyst (CDA)
by Epda in Data Analyst
Biostatistician (BS)
by Epda in Biostat
Statistical Programmer (SP)
by Epda in Programmer
Data Capture Specialist (DCS)
by Epda in Data Specialist
Clinical Data Analyst (CDA)
by Epda in Data Analyst
JOB DETAILS
Job Role Insight
Offered salary
as-per industry standards
Career level
Junior
Qualification
Associate
Experience
1 - 2 Years
Quantity
2 person
Hiring location
Hyderabad
Description
Overview
The Clinical Data Analyst (CDA) shall be responsible for data processing activities on a project and shall ensure quality standards according to SOPs and ICH-GCP. The CDA shall support the Project Lead on a project on tasks as needed.
Responsibilities:
- Review the respective study protocol/CRF
- Prepare Data Management Plan
- Track and review CRFs
- Create of Data Validation Specification (considering inputs from programming department and client requirements)
- Perform data cleaning (manually or automatically) and generate DCFs (Data Clarification Form).
- Perform / FUP on medical coding availability
- Ensure implementation of all data processing quality steps as per SOPs
- Support DCS team where required
- Data Management QC as per project specific defined process
- Database review and provide inputs as needed
- Adhere to EPDA SOPs as per task assigned
- Ensure documentation availability as per SOPs
- Check progress of project and escalate to PLCDA for immediate actions when required
- Support PLCDA on assigned projects when neededSupport PLCDA on assigned projects when needed
Education:
Bachelor’s degree (or equivalent) in a life science field, medical qualification or relevant Data Management experience.
Experience & Skills:
- At least 2 year of experience in a similar role in clinical research environment
- Experience in using any EDC system or SAS is preferred
- Good background and understanding of clinical studies
- Ability to work in a fast-paced environment
- Basic knowledge of SAS (LINUX, UNIX or PC)
- Good knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG)
- Awareness of all relevant regulations, including GCP
- Good in written and oral communication
Request to send the Resume to: hr@epda.in
Biostatistician (BS):
by Epda in Biostat
JOB DETAILS
Job Role Insight
Offered salary
as-per industry standards
Career level
Junior
Qualification
Associate
Experience
1 - 2 Years
Quantity
2 person
Hiring location
Hyderabad
Description
Overview
Provide data analysis with accurate statistical methods as inputs and contribute in conclusion or making predictions of BA/BE and Clinical trial studies. Provide and assist in the development of project-related statistical analysis.
Responsibilities:
- Works with medical writing team to decide on appropriate study design and statistical methodology and provide statistical inputs in the preparation of clinical trial protocols
- Estimation of sample size and power for clinical studies
- Preparation of Randomization of subjects for clinical studies as per the study protocol
- Responsible for statistical issues pertaining to the study such as outliers, missing data and data management
- Responsible for statistical integrity, adequacy & accuracy of data used
- Review of statistical analysis for clinical studies as per respective protocols
- Review of reported statistical results which include information in the form of graphs, charts and tables
- Analyze and interpret statistical data to identify significant differences in relationships among sources of information
- Responsible for review of aCRF, CDISC Datasets (SDTM and ADaM domains) and define files
- Preparation of standard operating procedures, statistical analysis plans and work instructions for statistical analysis
- Provides accurate and timely answers to routine queries from clients pertaining to statistics
- Responsible for co-ordinating with the technical team for installation or renewal or validation of softwares pertaining to pharmacokinetics and statistics on timely basis or as and when required
- Preparation and Review of Randomization schedules and statistical analysis of IVPT/IVRT studies
Education:
Master’s / bachelor’s degree computer science or statistics or related field.
Experience & Skills:
- 2-year relevant experience; or equivalent combination of education, training and experience
- Experience in SAS programming for multiple phase clinical trials in a pharmaceutical/CRO environment
- Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. Proven experience with Unix, Linux and Windows operating systems
- Proficient in written and oral communication
Request to send the Resume to: hr@epda.in
Statistical Programmer (SP):
by Epda in Statical Programmer
JOB DETAILS
Job Role Insight
Offered salary
as-per industry standards
Career level
Junior
Qualification
Associate
Experience
1 - 2 Years
Quantity
2 person
Hiring location
Hyderabad
Description
Overview
Provide Programming proficiency to develop and maintain programs to meet internal and external standards. Provide and assist in the development of project-related solutions to a wide range of statistical programming tasks.
Responsibilities:
- Working to ICH GCP and other applicable industry standards
- Review the respective study protocol/CRF
- Creation /Review of annotated CRFs
- Creation /Review of Data specifications
- Develop edit checks programming per the data validation plan or data management plan
- Write SAS programs to generate tables, listings, and figures and analysis datasets
- Develop programming for CDISC deliverables (SDTM, ADaM and define.xml)
- Communicate with programming and statistics leads
- Assist in the development of programming documentation including specifications, as appropriate, under supervision
- Reconciliation of external data
- Perform quality control on final datasets, reports
- Prepare and review Data Transfer Agreements
- Develop SAS macros as needed
- Understand and adhere to organization defined standard operating procedures (SOPs)
- Fulfil project responsibilities at the level of assisting the statistical programming lead
Education:
Master’s / bachelor’s degree computer science or biostatistics or related field.
Experience & Skills:
- 2-year relevant experience; or equivalent combination of education, training and experience
- Experience in SAS programming for multiple phase clinical trials in a pharmaceutical/CRO environment
- Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. Proven experience with Unix, Linux and Windows operating systems
- Proficient in written and oral communication
Request to send the Resume to: hr@epda.in
Data Capture Specialist (DCS)
by Epda in Data Specialist
JOB DETAILS
Job Role Insight
Offered salary
as-per industry standards
Career level
Junior
Qualification
Associate
Experience
1 - 2 Years
Quantity
2 person
Hiring location
Hyderabad
Description
Overview
The Data capture specialist (DCS) is responsible for the direct oversight of CRF data entry and quality control as well as effective communication with internal and external customers in order to meet study data timelines.
Responsibilities:
- Review the respective study protocol/CRF
- Enter data in databases with different data entry tools as per data entry guidelines
- Provides additional quality checks inputs of study data with to the assigned mentor
- Provide immediate feedback to assigned mentor if any procedure / form is missing or found not able to process
- Contribute to preparation of validation checks on clinical data
- Being faithful to agreed timelines
- Adhere to EPDA SOPs as per task assigned
- Ensure documentation availability as per SOPs of the task assigned
- Participate in trainings and continue to learn and to implement new data entry and systems
- Support in administrative work for Data Management team
- Support CDA on assigned projects when needed
Education:
Any life sciences diploma or degree.
Experience & Skills:
- Prior data entry experience. (life sciences will be added advantage). (0 to 1 year)
- Demonstrate knowledge of using data entry methods
- Understanding of clinical terminology
- Ability to work in a fast-paced environment
- Good computer skills
- Good English knowledge