Clinical Data Svs Sr Analyst

Accenture PLC; Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Accenture PLC is seeking a Clinical Data Svs Sr Analyst in Mumbai to join Life Sciences RD. The role involves analysis, SAS programming, and managing SDTM datasets for regulatory submissions.

Ideal candidates have BE/MSc/Bachelor of Pharmacy and 4–8 years of experience in clinical data services, with strong communication and problem-solving skills and willingness to work in shifts.

Qualifications

• BE/MSc/Bachelor of Pharmacy required.
• 4 to 8 years of experience.
• Experience with SAS programming preferred.
• Clinical Data Services domain knowledge.

Responsibilities

• Analyze and solve increasingly complex problems.
• Develop SAS programs to generate SDTM datasets and outputs.
• Validate SDTM datasets, tables, listings and figures.
• Mentor new hires and assist with delivery.

Skills

Written and verbal communication

Teamwork

Agility for quick learning

Problem-solving skills

Education

BE/MSc/Bachelor of Pharmacy

Tools

SAS

SDTM

Job description

About The Role

Skill required: Clinical Data Services - Medical Monitoring

Designation: Clinical Data Svs Sr Analyst

Qualifications:BE/MSc/Bachelor of Pharmacy

Years of Experience:4 to 8 years

Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Songall powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.

What would you do

You will be aligned with our Life Sciences RD vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance Regulatory, helping the world s leading biopharma companies bring their vision to life s enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Clinical Data Services involve the management and processing of data collected during clinical trials. This includes data collection, validation, storage, and analysis to ensure the data is accurate and reliable. The goal is to support clinical research by providing high-quality data that can be used to evaluate the safety and efficacy of medical treatments. These services are essential for regulatory compliance and successful trial outcomes. They often utilize specialized software and systems to manage the data efficiently.Provides medical expertise for trial oversight and safety concerns. This includes creation, review and validation of protocol requirement specifications as per the applicable SOP.

What are we looking for

• Written and verbal communication
• Ability to work well in a team
• Agility for quick learning
• Problem-solving skills

Roles and Responsibilities

• In this role you are required to do analysis and solving of increasingly complex problems
• Your day to day interactions are with peers within Accenture
• You are likely to have some interaction with clients and/or Accenture management
• You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments
• Decisions that are made by you impact your own work and may impact the work of others
• In this role you would be an individual contributor and/or oversee a small work effort and/or team
• Please note that this role may require you to work in rotational shifts
• Review approved Protocol and Study Setup documents
• Develop SAS programs/run standard macros for generating SDTM Like Datasets, SDTM Datasets Tables, Listings, Figures and Trial Specific Outputs
• Perform and document developer testing
• Responsible for validation of the SDTM Like Datasets, SDTM datasets, Tables Listings Figures and Trial Specific Outputs
• Extract data from available databases and place data into SAS or other types of data files.
• Create and review Submissions Documents, Specifications for safety/standard outputs.
• Adhere to all client and Accenture SOPs as applicable
• Enhance technical skills relevant to statistics and programming
• Complete all required and adequate trainings
• Mentor new hires associates in their new roles, assist with questions, and provide guidance for successful delivery.
• To carry out other responsibilities as and when assigned by the India Service Delivery Lead/Statistical Programmer Manager/Senior Statistical Programmer.
• QualificationBE,MSc,Bachelor of Pharmacy