Senior Clinical Programmer

2 days ago


Mumbai Maharashtra, India Novartis Full time

Summary Participate in the full lifecycle of producing key data and or reports in support of data review reporting development including evaluation of requirements design specifications interface to programmers report programming coordinate validation and rollout activities along with providing quantitative analytical support These tasks are to be performed independently or team based with minimal guidance and supervision Major accountabilities Produce and track reports for various line functions within Global Drug Development used for ongoing monitoring of clinical data 2 Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders 3 Author co-author the user requirements document functional specifications and functional testing scripts 4 Facilitate interaction with end-user on creating specifications and working with programmers or performing the programming activities for successful delivery 5 To provide quantitative analytical support to the global program teams including providing support on analyzing reports 6 Support the planning execution and close-out of Clinical Programs Trials 7 Support the management in collation and delivery of analytics reports for critical decision making 8 Create file and maintain appropriate documentation 9 Work with the internal SMEs and key stakeholders in providing analysis and interpretation of clinical program trial operational data 10 Provide necessary training to end-user on best appropriate and consistent use of various data review tools 11 Program reports of various complexity from documented requirements within the clinical reporting systems using SQL PL SQL C VB script SAS Python R 12 Good Knowledge of Novartis Clinical Data Standards and its implementation for creation of reports specifications or reports output 13 Support special projects of limited scope sub team lead local project etc both clinical and non-clinical in nature 14 Provide study level expertise and involvement in CTTs 15 Lead or provide support to special projects both clinical and non-clinical in nature or in general areas spanning various responsibilities but not limited to systems issues processes user support training etc Key performance indicators 1 Quality and timeliness of deliverables 2 Revisions to deliverables caused by logic or programming errors 3 Customer feedback and satisfaction Minimum Requirements Work Experience At least 5-7 years experience in clinical review and reporting programming business analytics and or clinical trial setup gained in the pharmaceutical industry CRO or Life Science related industry as well as the following o Strong knowledge of programming languages SQL PL SQL C VB script SAS Python R o Strong knowledge of Data Review and or Business Intelligence tools such as Spotfire JReview o Knowledge of clinical data management systems and or relational databases e g OC RDC INFORM RAVE as applied to clinical trials o Attention to detail quality time management and customer focus o Ability to translate technical concepts for nontechnical users in the areas of clinical database design and data review reporting development o Strong verbal and written communication skills to work with our global partners and customers o Understanding of Drug Development Process ICHGCP CDISC standards and Health Authority guidelines and regulations o Ability to train and supervise new or less experienced associates Skills Desired Clinical Trials Computer Programming Data Analysis Programming Languages Reporting Statistical Analysis



  • Pune, Maharashtra, India Syneos - Clinical and Corporate - Prod Full time

    **Description** Principal Clinical Programmer Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...


  • Mumbai, Maharashtra, India Novartis Full time

    Summary The Senior Principal Programmer is responsible for all statistical programming aspects of several studies a medium to large sized project or project-level activities incl submission and postmarketing activities The position is a key collaborator and strategic partner with biostatistics in ensuring that pharmaceutical drug-development plans in...


  • Mumbai, Maharashtra, India Tata Consultancy Services Full time

    **Role** - EDC (Veeva & Inform Programmer) **Exp Range** - 5 to 11 years of experience. **Location** - Mumbai/ Pune/ Bangalore **Key Accountabilities** - Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process - Create edit check specifications and program or modify checks at study level within...


  • Pune, Maharashtra, India Lifelancer Full time

    Job Title Senior Statistical Programmer FSP Job Location India Job Location Type Remote Job Contract Type Full-time Job Seniority Level Mid-Senior level Sponsor-dedicated JOB DESCRIPTION Working fully embedded within one of our pharmaceutical clients with the support of Cytel right behind you you ll be at the heart of our client s innovation As a Senior...


  • Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Job Title:Clinical Quality Assurance Compliance & trainingExperience: 5 plus yearsLocation:MumbaiType:Full-timeExperience Level:[Senior] Manager/Senior ManagerDepartment:Clinical Research DepartmentPurpose of this Role:This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable...

  • Clinical Programmer

    2 weeks ago


    Mumbai, Maharashtra, India Novartis Full time

    **Summary**: - Responsible to support all statistical programming/data review reporting and analytics development aspects of assigned studies or project-level activities. **About the Role**: **Major accountabilities**: - Uses professional concepts and company's policies and procedures to solve a variety of problems. - Contribute to statistical...


  • Mumbai, India Maxis Clinical Sciences Full time

    Job Title: Clinical Quality Assurance Compliance & training Experience : 5 plus yearsLocation: MumbaiType: Full-timeExperience Level: (Senior) Manager/Senior ManagerDepartment: Clinical Research DepartmentPurpose of this Role:This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be...


  • Mumbai, India Maxis Clinical Sciences Full time

    Job Title: Clinical Quality Assurance Compliance & trainingExperience: 5 plus yearsLocation: MumbaiType: Full-timeExperience Level: [Senior] Manager/Senior ManagerDepartment: Clinical Research Department Purpose of this Role:This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be...


  • Mumbai, India Maxis Clinical Sciences Full time

    Job Title: Clinical Quality Assurance Compliance & training Experience : 5 plus years Location: Mumbai Type: Full-time Experience Level: (Senior) Manager/Senior Manager Department: Clinical Research Department Purpose of this Role: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be...


  • Mumbai, India Maxis Clinical Sciences Full time

    Job Title: Clinical Quality Assurance Compliance & training Experience : 5 plus years Location: Mumbai Type: Full-time Experience Level: (Senior) Manager/Senior Manager Department: Clinical Research Department Purpose of this Role: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be...