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5.0 - 9.0 years

0 Lacs

navi mumbai, maharashtra

On-site

The Statistical Programming Manager position is a full-time opportunity based in Mumbai, India, within the Biostatistics team. As a Statistical Programming Manager, you will play a crucial role in supporting project teams on programming matters, managing programming staff, ensuring high-quality delivery, providing leadership and training for the Programming group, and leading the development of Programming standards to maximize efficiencies. To qualify for this role, you should hold a Bachelor/Master's degree in statistics, mathematics, health informatics, computer science, or a related field. Additionally, you should have proficiency in SAS programming skills, at least 5 years of clinical programming experience, strong communication and coordination skills, and good leadership abilities. Medpace is a full-service clinical contract research organization committed to accelerating the global development of safe and effective medical therapeutics. With expertise in various therapeutic areas including oncology, cardiology, metabolic disease, and central nervous system among others, Medpace is dedicated to making a positive impact on the lives of patients worldwide. Joining Medpace offers a range of benefits including a flexible work environment, competitive compensation and benefits package, structured career paths, employee appreciation events, and health and wellness initiatives. Furthermore, Medpace has been recognized by Forbes as one of America's Most Successful Midsize Companies and has received multiple CRO Leadership Awards for expertise, quality, and reliability. If you are looking for a rewarding career where you can utilize your programming skills, lead a team, and contribute to the development of life-changing medical therapeutics, then consider applying for the Statistical Programming Manager position at Medpace. We look forward to reviewing your qualifications and potentially contacting you for the next steps in the recruitment process.,

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5.0 - 9.0 years

0 Lacs

chennai, tamil nadu

On-site

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team (hybrid*). The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, you will manage, coordinate, review, and approve DM deliverables from database design & set-up, through cleaning and reporting to database locking. It is crucial to ensure that the completeness, accuracy, and consistency of clinical data meet the quality standards and regulatory requirements for analysis and reporting. Additionally, you will provide expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. You will also be involved in Request for Proposals (RFPs) and present at Business Development (BD) Meetings. As a Senior Clinical Data Manager I, your key tasks will include: - Leading and serving as the primary contact for DM with all relevant parties internally and externally - Planning and projecting the resources required including management of tasks, timelines, risk, and quality - Developing, reviewing, and maintaining project-specific DM documents throughout the project lifecycle - Leading and coordinating the development of clinical study database set-up, eCRF design, and database validation requirements - Creating training materials for EDC users and providing project-specific training - Overseeing data cleaning strategy, data releases, data transfers, and reconciliation activities - Providing project metric reports, status updates, study progress, and feedback to the project team - Maintaining DM study documentation, supporting internal and external audits, and aligning data management and clinical programming best practices - Participating in client evaluations, preparing new proposals and budgets for Data Management services, and staying updated on regulatory development trends Requirements: - Life science, healthcare degree and/or combination of education and experience - Minimum 5 years of relevant work experience as a Clinical Data Manager - Thorough knowledge of ICH-GCP, 21CFR11 data privacy guidelines, and awareness of local/regional requirements - Experience with EDC software systems, IRT, eCOA, and CDISC conventions - Strong written and verbal communication skills, organizational, negotiating, and motivational skills - Ability to work in a fast-paced challenging environment and proficiency with computer applications Benefits of working at Allucent include: - Comprehensive benefits package - Competitive salaries - Departmental Study/Training Budget for professional development - Flexible working hours and remote/office-based working opportunities - Leadership and mentoring opportunities - Internal growth opportunities, employee referral program, and access to online training platforms *This position is for the Chennai Location and not home-based** *Please note that Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any open roles. Candidates should never be submitted directly to hiring managers, employees, or human resources.*,

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5.0 - 9.0 years

0 Lacs

navi mumbai, maharashtra

On-site

The company's corporate activities are expanding rapidly, and we are currently in search of a full-time Statistical Programming Manager to join our Biostatistics team in India, Mumbai. In this role, you will collaborate with a team to complete tasks and projects crucial to the company's success. If you are seeking a dynamic career where you can utilize your existing skills and further advance your professional development, this opportunity is ideal for you. As the Statistical Programming Manager, your responsibilities will include providing support to project teams on programming issues, overseeing programming staff, coordinating task assignments, and reviewing activities to ensure high-quality delivery. Additionally, you will offer leadership and training to the Programming group, ensure that all projects meet objectives and timelines, and spearhead the development of Programming standards, applications, and processes to enhance efficiencies. To qualify for this position, you should hold a Bachelor's or Master's degree in statistics, mathematics, health informatics, computer science, or a related field. Proficiency in SAS programming skills, at least 5 years of clinical programming experience, strong communication and coordination skills, as well as good leadership abilities are also required. Medpace is a full-service clinical contract research organization (CRO) dedicated to providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. With headquarters in Cincinnati, Ohio, we have a global presence in over 40 countries and employ more than 5,000 individuals. At Medpace, we believe in People, Purpose, and Passion, and we strive to make a Difference Tomorrow. Join us today to be a part of our impactful work that has positively influenced the lives of numerous patients and families facing various diseases. Your contributions today will help improve the lives of individuals dealing with illness and disease in the future. Medpace offers a range of perks including a flexible work environment, competitive compensation and benefits package, structured career paths with opportunities for professional growth, company-sponsored employee appreciation events, and employee health and wellness initiatives. We have been recognized by Forbes as one of America's Most Successful Midsize Companies from 2021 to 2024 and have received multiple CRO Leadership Awards from Life Science Leader magazine for our expertise, quality, capabilities, reliability, and compatibility. If you are interested in joining our team, a Medpace representative will review your qualifications and reach out to you with further details on the next steps. Medpace is an Equal Opportunity/Affirmative Action Employer committed to diversity and inclusion.,

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5.0 - 9.0 years

0 Lacs

chennai, tamil nadu

On-site

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team in the Chennai location. The Senior Clinical Data Manager I (SrCDM1) will be responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, your key tasks will include leading and serving as the primary contact for DM with all relevant parties both internally and externally, planning and projecting the resources required, monitoring tasks against budgets and forecasts, and developing, reviewing, and maintaining project-specific DM documents. You will also lead and coordinate the development of clinical study database set-up, participate in the review of study documents, coordinate database User Acceptance Testing (UAT), create training materials for EDC users, oversee data cleaning and validation, and manage various data transfers and reconciliation activities. Additionally, you will provide project metric reports, status updates, study progress, and feedback to the project team, organize and lead Quality Review activities during the study, assist in project-related contracts negotiation, and manage the database maintenance, lock, and close-out processes. You will also participate in conference calls and meetings with vendors and sponsors, maintain DM study documentation, support internal and external audits, align data management and clinical programming best practices, and provide leadership and support to other department members. To be successful in this role, you should possess a life science or healthcare degree, a minimum of 5 years of relevant work experience as a Clinical Data Manager, thorough knowledge of ICH-GCP, 21CFR11 data privacy guidelines, and experience with electronic data capture software systems. You should also have experience as a DM lead on several studies, strong written and verbal communication skills, strong project management skills, and the ability to simplify complex issues into understandable concepts. Benefits of working at Allucent include a comprehensive benefits package, competitive salaries, departmental study/training budget, flexible working hours, opportunity for remote/office-based working, leadership and mentoring opportunities, internal growth opportunities, access to online training, eligibility for Spot Bonus Award Program, and eligibility for Loyalty Award Program. Please note that office-based employees are required to work in-office for a minimum number of days per work week. Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on open roles. Candidates should never be submitted directly to hiring managers, employees, or human resources.,

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4.0 - 8.0 years

8 - 12 Lacs

Pune

Work from Office

Description Senior Clinical Programmer (Rave+ Custom Function) Syneos Healthis 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 to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong Job Responsibilities Programming and testing database design and implementation, ensuring data integrity and compliance with regulatory standards Coordinating business reporting for regional or transnational use, including the development and maintenance of reporting tools and dashboards Providing technical expertise to data management teams, offering guidance on best practices and troubleshooting complex issues Offering technical expertise to internal and external clients, including the preparation and presentation of technical documentation and reports Contributing to the design, implementation, and delivery of processes, programs, and policies, ensuring alignment with organizational goals and objectives Managing processes and programs, potentially directing the work of lower-level professionals, and ensuring timely and accurate completion of tasks Ensuring efficient and effective execution of technical aspects of clinical programming, including the development and validation of programming code and algorithms Collaborating with cross-functional teams to ensure data integrity and compliance, including participation in project meetings and providing input on technical aspects of clinical programming Developing and maintaining documentation for database design and implementation, including standard operating procedures and technical manuals Troubleshooting and resolving technical issues related to clinical programming, including the identification and implementation of corrective actions Qualifications Bachelor's degree in Computer Science, Information Technology, or related field 5+ years of experience in iMedidata Rave Clinical Programming that includes basic and advance Study buildup activities, eCRF Design, Edit Check Programming, System Migration Good experience with Custom Function Programming Excellent Communication Skills Proficiency in programming languages such as SQL, SAS, or R Strong understanding of database design and implementation Excellent problem-solving and analytical skills Ability to work independently and as part of a team Strong communication and interpersonal skills Certifications Certified Clinical Data Manager (CCDM) or equivalent certification preferred SAS Certified Professional or equivalent certification preferred Necessary Skills In-depth knowledge of clinical programming and database design Ability to manage multiple projects and prioritize tasks effectively Strong attention to detail and accuracy Ability to provide technical expertise and guidance to team members Proficiency in data management and reporting tools Understanding of regulatory requirements and compliance standards Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health http://www syneoshealth com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job Summary Roles within Clinical Programming job family at the P22 level are responsible for programming and testing database design, implementation, and business reporting This includes planning and coordinating database design, implementation, and business reporting for regional or transnational use These roles provide technical expertise to data management teams and offer technical expertise to internal and external clients Impact and Contribution Roles within Clinical Programming job family at the P22 level contribute significantly to the design, implementation, and delivery of processes, programs, and policies They use their in-depth knowledge and skills within the professional discipline to understand the impact of their work on related areas These roles may be responsible for entire projects or processes within their area of responsibility, ensuring that the technical aspects of clinical programming are executed efficiently and effectively Core Focus Programming and testing database design and implementation Coordinating business reporting for regional or transnational use Providing technical expertise to data management teams Offering technical expertise to internal and external clients Contributing to the design, implementation, and delivery of processes, programs, and policies Managing processes and programs, potentially directing the work of lower-level professionals Ensuring efficient and effective execution of technical aspects of clinical programming

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1.0 - 6.0 years

20 - 25 Lacs

Hyderabad

Work from Office

What Youll Do Lead programming activities across studies and clinical development phases Oversee CRO deliverables for quality, timeliness, and regulatory compliance Provide technical oversight for SDTM, ADaM, Define.xml, DRGs, and TLFs Were Looking For 8-12 years clinical programming exp. with leadership exposure Expert SAS skills (Base, Macro, SQL); strong SDTM, ADaM, Define.xml, TLF experience Bachelor's/Master's in Statistics, CS, Life Sciences, or related field Proven CRO management experience across selection, oversight, and delivery Strong Hands-on R skills for exploratory analysis and visualization Preferred: Familiarity with Pinnacle 21, CDISC validation, ISS/ISE, and automation tools

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5.0 - 10.0 years

5 - 10 Lacs

Navi Mumbai

Work from Office

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Statistical Programming Manager to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Provide support to project teams on programming matters; Manage programming staff, coordinate task assignments and review activities/progress to ensure high quality delivery; Provide leadership and training for the Programming group; Ensure all projects within the team meet objectives and timelines; and Lead the development of Programming standards, applications and processes to maximize efficiencies. Qualifications Bachelor/Master degree in statistics, mathematics, health informatics, computer science, or related field; Proficiency in SAS programming skills; 5 years of clinical programming experience; Strong communication skills and coordination skills; and Good leadership skills. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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4.0 - 9.0 years

9 - 19 Lacs

Bengaluru

Remote

Position: Clinical Programmer Experience: 4-9 Years Job Location: Remote Job Description: Minimum of 4+ years of experience in clinical programming for clinical data management in the pharmaceutical or CRO industry. Experience working with different EDC systems (e.g., Medidata Rave, Veeva, Oracle Clinical). Proficient in Python /SAS for data manipulation & automation. Experience in data cleaning , querying , and performing manual & automated data checks to ensure data integrity. Hands-on experience in data visualization and dashboard creation using Power BI , Spotfire , or other BI tools. Thorough knowledge of Data Collection and industry data standards . A person with bachelors or masters degree in computer science, Life Sciences, Biostatistics, or related field.

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3.0 - 8.0 years

6 - 15 Lacs

Ahmedabad, Bengaluru

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Hi, We are hiring for ITES Company for Spotfire Programmer Role. Job description: Minimum 3 years of experience as a Spotfire Programmer and Clinical experience is Mandatory Working on Refreshes requests for SRT & CSTV Building Oncology & Standard Visuals for Clinical Study Team Visualization (CSTV) Setting up standard and Study Specific Spotfire requests for Safety Review Team (SRT) Knowledge of Spotfire, Study configuration tool and On Demand Tool. Creating SAS Codes as per the requirement Setup and customization of visuals for Medical Reviewers Validation of visuals as per the specifications Optimize data models and queries for improved performance and scalability. Monitor and troubleshoot issues related to the Spotfire platform and coordinate with vendors for advanced support. Seeking opportunities to leverage expertise in Spotfire development and data visualization to contribute to the success of a data-driven organization. Integrate and prepare data, create visualizations and reports, optimize performance, and collaborate with stakeholders. Possesses a strong understanding of data exploration, ETL processes, and programming in R. Adept at collaborating with clients and stakeholders to translate complex data into clear and actionable insights. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Bangalore ) Type : Job Code # 80 b) To Apply for above Job Role ( Ahmedabad ) Type : Job Code # 82

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4.0 - 8.0 years

10 - 20 Lacs

Pune, Bengaluru, Mumbai (All Areas)

Work from Office

Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: 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 EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models • Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 181 b) To Apply for above Job Role ( Pune ) Type : Job Code # 182 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 183

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4.0 - 9.0 years

10 - 20 Lacs

Pune, Bangalore Rural, Mumbai (All Areas)

Work from Office

Hi We're hiring for Leading ITES Company for EDC (Veeva Programmer) Role Experience in EDC & Veeva is Must. Job Description : 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 EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,)) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks. Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit. Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables. Adaptable to new ways of working using technology to accelerate clinical trial setup Education and Experience Requirements: Bachelor's degree or related experience. Knowledge of drug development process. Minimum of 4+ years experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields. Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,) Experience programming in CQL, working with JSON format and/or C# is preferred Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint) To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 181 b) To Apply for above Job Role ( Pune ) Type : Job Code # 182 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 183

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5.0 - 10.0 years

10 - 15 Lacs

Pune, Mumbai (All Areas)

Work from Office

Hi , We are hiring for Leading ITES Company for SDTM Programmer Profile. Please go through the JD and we will get back to the relevant profiles. Job Description: Minimum 3 years of experience for Senior Statistical programming is a mandate. Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Experience in SDTM, ADAM & TLF Experience in EDC & VEEVA Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 208 b) To Apply for above Job Role ( Pune ) Type : Job Code # 209

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3.0 - 6.0 years

4 - 7 Lacs

Bengaluru

Work from Office

As a Clinical Data Coordinator you will be joining the worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence, Communicate with team members to ensure activities progress Team members include Clinical Programming team, CDSP team, or CDM teams, for example Ensure communication/messaging is appropriate for audience Manage study-specific documentation Create/review guidance documents Participate in CDSP meetings Create and manage CDSP configuration timeline for Launch I and IA activities Metadata activities Create and manage metadata for standards and studies Update metadata as required for study protocol amendments and post go live updates to the EDC and/or DTS Understand the validator, standards, and metadata functionalities in elluminate Experience Required: 3-5 years This role is specific to COMPASS, requiring candidates with 3-5 years of experience What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers iconplc,com/benefits At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status https://careers iconplc , com / reasonable-accommodations Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles,

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5.0 - 9.0 years

7 - 11 Lacs

Kolkata, Mumbai, New Delhi

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ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development, Job Title: Senior Lead Clinical Data Science Programmer [Elluminate] Location : Chennai/ Bangalore What You Will Be Doing Develop, implement and maintain date review and data cleaning capabilities for sponsors led Phase I-IV clinical trials using sponsors technologies in support of efficient study execution and related decision-making including incorporation of emerging approaches to such activities Contributes to related technical and/or process improvement initiatives associated with data reporting and analytics across DS and Astellas broadly Collaborates with any vendors providing data reporting and analytical capabilities and/or support for such capabilities Collaborates cross functionally to ensure that any issues with the data reporting and analysis are addressed as appropriate You Are BS or MS degree, preferably in Computer Science, Informatics/Data Science, or life science discipline Prior pharma or CRO industry experience working on global clinical studies and projects or global process and system initiatives Prior experience in Reporting [Elluminate or Cluepoint] Strong verbal and written communication skills What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers iconplc /benefits At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status https://careers iconplc /reasonable-accommodations Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles,

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4.0 - 8.0 years

6 - 10 Lacs

Kolkata, Mumbai, New Delhi

Work from Office

ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development, Job Title: Clinical Data Enablement Data Aggregation Lead Location : Chennai/ Bangalore What You Will Be Doing Enable the data flow for Phase I-IV clinical trials consistent with aligned commitments inclusive of data ingest, transformation and internal availability of this data for data review, data cleaning and readiness for data analysis Works directly with vendors providing source data (i-e vendors providing lab results, ECGs, biomarkers, etc ?) and/or internal functions such as clinical operations or early development to ensure that related specifications, mechanisms for data transfers and data transfer schedules are established and executed appropriately Contributes to related technical and/or process improvement initiatives associated with the clinical results data flow and efforts within the department and across sponsors broadly Collaborates with vendors providing capabilities and/or support for the clinical data flow to ensure successful delivery of study level data Collaborates cross functionally with areas performing data management, clinical operations, IT support, etc to address any issues with the delivery or stability of the clinical data flow as appropriate You Are BS or MS degree, preferably in Computer Science, Informatics/Data Science, or life science discipline Prior pharma or CRO industry experience working on global clinical studies and projects or global process and system initiatives Prior experience with systems and processes that include an end-to-end data flow and the transformation of data in support of data review and/or data cleaning Strong verbal and written communication skills What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers iconplc /benefits At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, https://careers iconplc /reasonable-accommodations Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles,

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5 - 10 years

10 - 15 Lacs

Pune, Mumbai (All Areas)

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Hi , We are hiring for Leading ITES Company for SDTM Programmer Profile. Please go through the JD and we will get back to the relevant profiles. Job Description: Minimum 3 years of experience for Senior Statistical programming is a mandate. Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Experience in SDTM, ADAM & TLF Experience in EDC & VEEVA Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Statistical Programmer Mumbai (Job Code # 208) b) For Position in Pune Search : Statistical Programmer Pune (Job Code # 209)

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4 - 8 years

10 - 20 Lacs

Pune, Bengaluru, Mumbai (All Areas)

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Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: 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 EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models • Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 181 b) For Position in Pune Search : Job Code # 182 C) For Position in Bangalore Search : Job Code # 183

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4 - 9 years

10 - 20 Lacs

Pune, Bangalore Rural, Mumbai (All Areas)

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Hi We're hiring for Leading ITES Company for EDC (Veeva Programmer) Role Experience in EDC & Veeva is Must. Job Description : 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 EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,)) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks. Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit. Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables. Adaptable to new ways of working using technology to accelerate clinical trial setup Education and Experience Requirements: Bachelor's degree or related experience. Knowledge of drug development process. Minimum of 4+ years experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields. Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,) Experience programming in CQL, working with JSON format and/or C# is preferred Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint) To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : EDC Veeva & Inform Programmer Mumbai (Job Code # 181) b) For Position in Pune Search : EDC Veeva & Inform Programmer Pune (Job Code # 182) c) For Position in Bangalore Search : EDC Veeva & Inform Programmer Bangalore (Job Code # 183)

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7 - 12 years

20 - 30 Lacs

Hyderabad

Remote

Primary Job Function Responsible for the integrity of the programming/computing solutions for multiple clinical trials (or equivalent) and/or publication activities. In collaboration with the Biostatistician and Senior Programmer, provide programming support to project-level programming deliverables and other adhoc programming requests. Roles and Responsibilities Ensure understanding and compliance with study and project programming standards. Responsible for development of programming specification. Create and Validate Safety and Efficacy Analysis Datasets in adherence with CDISC and client specific standards and maintain quality and accuracy. Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy. Create Study specific or general macros and finalize programming specifications/mock-ups. Adhere to programming specifications and study specific requirements, including completion and filing of required documentation. Plan and organize workload to ensure effective time management and adherence to project specific timelines. Proactively plan for and implement effective resource planning, task allocation and tracking of workload in accordance with agreed KPIs and quality standards Trouble-shoot and resolve programming issues in a timely and efficient manner. Ability to work independently and as part of a team environment. Strong problem solving and organizational skills, attention to detail, verbal and written communications skills Desired Candidate Profile Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy. Very strong SAS programming skills required in SAS/Base, PROC SQL,SAS/Stat, SAS Macros and SAS/Graph (Base and Advance SAS). Good communications and negotiation skills, ability to work well with others globally.

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4 - 8 years

10 - 20 Lacs

Pune, Bengaluru, Mumbai (All Areas)

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Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: 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 EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models • Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 181 b) For Position in Pune Search : Job Code # 182 C) For Position in Bangalore Search : Job Code # 183

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3 - 8 years

6 - 15 Lacs

Ahmedabad, Bengaluru

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Hi, We are hiring for ITES Company for Spotfire Programmer Role. Job description: Minimum 3 years of experience as a Spotfire Programmer and Clinical experience is Mandatory Working on Refreshes requests for SRT & CSTV Building Oncology & Standard Visuals for Clinical Study Team Visualization (CSTV) Setting up standard and Study Specific Spotfire requests for Safety Review Team (SRT) Knowledge of Spotfire, Study configuration tool and On Demand Tool. Creating SAS Codes as per the requirement Setup and customization of visuals for Medical Reviewers Validation of visuals as per the specifications Optimize data models and queries for improved performance and scalability. Monitor and troubleshoot issues related to the Spotfire platform and coordinate with vendors for advanced support. Seeking opportunities to leverage expertise in Spotfire development and data visualization to contribute to the success of a data-driven organization. Integrate and prepare data, create visualizations and reports, optimize performance, and collaborate with stakeholders. Possesses a strong understanding of data exploration, ETL processes, and programming in R. Adept at collaborating with clients and stakeholders to translate complex data into clear and actionable insights. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Spotfire Programmer Bangalore (Job Code # 80) b) For Position in Ahmedabad Search : Spotfire Programmer Ahmedabad (Job Code # 82)

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