178 Sdtm Jobs - Page 4

Summary The purpose of the role is to inventory all of the various data flowing into, across, and out of Novartis Statistical Compute Environments (SCE) and document data modalities, flows, storage, mappings and transformations, as a member of the SCAPE project team. The SCE is under development and will ultimately be used by the Development Advanced Quantitative Sciences (AQS) business domain. This role will collaborate with other SCAPE project workstreams and team members to ensure reliable and efficient data flows are established, documented and maintained according to project timelines and budget. Sound knowledge and experience in working with statistical compute and data science platforms Solid understanding of clinical trial processes and leveraging quantitative sciences and toolsets in regulatory and exploratory pathways Understanding of different data modalities (ex. Biomarkers, Omics, Imaging) Strong knowledge of Clinical data standards (CDISC – SDTM, ADAM, USDM) About The Role Key Responsibilities: Work across Business and IT to identify and document all data types, modalities, forms, etc. across current and future SCEs, including data from upstream and downstream systems relative to the SCEs. Assist SCAPE Project workstreams and team members to understand detailed data types, flows, and transformations relevant to the SCE so that SCE requirements are thoroughly understood and the SCAPE SCE solution delivery is of high quality and complete. Identify opportunities to optimize data flows and data transformations, increasing value to the Business. Take accountability for delivery of specific components / use cases for the SCE Ensure documented data flows and transformations support the development, execution and operations of the SCE Ensure peer review and sign off documentation. Coordinate with all other workstreams on the SCAPE project to deliver a quality SCE on time and within budget Education Essential Requirements Bachelor’s degree in computer science, Computer Engineering or related technical discipline or equivalent experience demonstrated Experience 7 years’ experience working in an IT environment with experience working in Biostats and quantitative science data platforms in Pharma Experience collaborating across geographical and organizational boundaries Advanced knowledge of Lean/ 6 Sigma, Design Thinking, Agile methodology Experience leading indirect reports in a matrix environment Advanced knowledge of Design Thinking and Agile methodology Demonstrated aptitude for learning Hands-on experience identifying and documenting data types, data modalities, and data flows across complex systems and system landscapes. Identifying opportunities for optimizations where possible. Leveraging digital technology and effective change management to deliver value. Track record delivering global solutions at scale, and interactions with senior management. Delivery of validated IT solutions and collaborating across boundaries. Experience in IT Enterprise & Business Architecture, IT Systems Design, IT Systems Integration, User Experience Design, Design Thinking, Analyzing stakeholder requirements, and Knowledge of IT Applications & tools. Experience with AI/ML and Experience with Domino is a plus Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Summary Assist in the timely & professional ongoing Mgmt of data Operations on Use Cases/Demand deliverables and of clinical data warehouse maintenance with respect to cost, quality and timelines within Clinical Pipeline team. Ensure high quality data available for secondary analysis use. Support content development and upgrade to training modules into engaging and interactive applications. Follows data regulations and laws, data-handling procedures and data mapping guidelines. Supports quality deliverables within Clinical Data Operations (DO). Manage data Load, Transfer from Novartis Clinical Data Lake and conform of Clinical trial data to SDTM/ADaM compliant standards within the Clinical Data Warehouse. Supports the delivery of quality data, processes and documentation contributor role in ensuring that use case/demands are executed efficiently with timely and high quality deliverables. About The Role Major accountabilities: Demonstrates potential for technical proficiency, scientific creativity, collaboration with others and independent thought. Under supervision provides input into writing specifications for use cases/demand and necessary reports to ensure high quality and consistent data -Involved in User acceptance testing (UAT) and managing data mapping activities to maintain Clinical Data Warehouse -Under supervision, participates in ongoing review of all data generated from different sources -Supports the development of communications for initiatives. Perform hands on activities to conduct data quality assessments. Creates under supervision and learns relevant data dictionaries, ontologies and vocabularies -Reporting of technical complaints / special case scenarios related to Novartis data Collaborate with other data engineering teams to ensure consistent CDISC based data standards applied Be familiar with all clinical study documents from protocol to CSR including Data Management and Biostatistic documents. Key Performance Indicators Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across Clinical Data Operations activities & deliverables. No critical data findings due to Data Operations-Adherence to Novartis policy, data standards and guidelines -Customer / partner/ project feedback and satisfaction Minimum Requirements Work Experience: 3-5 years of experience in working in clinical trials data reporting Collaborating across boundaries. Knowledge of clinical data Availability of sufficient information to find and understand data Availability of data quality assessments Experience in Agile way of working would be a plus Skills CDISC SDTM/ADaM Mapping Clinical Data Management. Experience in being able to work with different legacy, historical, local data standards SQL basic knowledges Python skills would be a plus Able to work in a worldwide team Data Privacy Data Operations. Data Science. Databases. Detail Oriented. Languages English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastructure for project files of SAS datasets and SAS code. Support Data Management in data set creations/transfers, integrity checks, and quality audits. Act as a liaison between clinical and subcommittees and project teams on an as-needed basis. Primary Responsibilities Perform or oversee team in performing all statistical programming required for clinical trial analysis and reporting on large scale projects of high complexity Apply appropriate statistical methods for data analysis and provide statistical programming expertise for project teams Review the Statistical Analysis Plan in preparation for programming the planned analyses Lead design/development of SAS macros and other utilities to expedite SAS programming activities Organize and conduct internal training sessions and author papers for conferences Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request Participate in statistical program validation and quality control activities Develop or review SDTM aCRF and specifications, ADaM specifications; complete programming and validation of CDISC SDTM and ADaM datasets Review pinnacle 21 reports and ensure compliance with CDISC and FDA guidelines Develop define.xml, study data reviewers guide and analysis datasets reviewers guide Identify study priorities and communicate effectively with project team and management Ensure quality, proper documentation and meet or exceed timely completion of the project within budgeted hours Manage statistical programming timelines, budgets, and client expectations Actively participate in study team meetings Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects Participate in review process of study documents such as the CRF, edit check specifications, and database design specifications written by Data Management Program data cleaning checks, as necessary, to assist Data Management's data cleaning activities Participate in installation/validation of statistical software packages throughout the software development lifecycle Develop and maintain the infrastructure for project files of SAS datasets and SAS code Mentor junior level statistical programmers by developing training plans and providing oversight of their work Ensure all programming activities and processes performed are conducted according to SDC's standard procedures and/or sponsor requirements Adhere to all aspects of the SDC's quality system Comply with SDC's data integrity & business ethics requirements Perform other related duties incidental to the work described herein Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Requirements Required Skills Strong analytical skills, with the ability to process scientific and medical data Very strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat, SAS Macros and SAS/Graph Strong problem-solving skills Able to work independently Excellent knowledge of statistical programming Proficient in manipulating and analyzing SAS data Ability to identify data issues, present problems, and implement solutions quickly Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues Good organizational and time management skills, with the ability to multi-task Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP). Expert knowledge of CDISC SDTM and ADaM data models Very strong interpersonal communication, presentation, and leadership skills SAS Base, Advance and Clinical Trials Certification is preferred Education Or Equivalent Experience Bachelor's degree in computer science, statistics or other related, scientific field and at least eight years of relevant professional experience; or an equivalent combination of relevant education and/or experience. Benefits Why SDC SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry. We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment We strive to provide a place of belonging to our employees with fun and engaging activities from SDC's culture club We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry With a proven track record, SDC has been successfully executing client clinical programs since 2005 Take a look at how you can join our team! Show more Show less

Job Title: Associate Director, Statistical Programming Introduction to role The Associate Director of Statistical Programming will oversee statistical programming activities for multiple clinical studies, maintain programming infrastructure, and ensure compliance with SOPs to produce quality and timely deliverables. This role requires extensive experience and proven skills in the use of SAS within a Statistical Programming environment, along with a complete understanding of statistical programming processes, procedures, and roles. The successful candidate will support Biostatistics in statistical analysis, including generating analysis data listings, tables, and figures, and creating all files necessary to support an electronic submission in the eCTD format. Additionally, strong people management and supervisory skills are essential to provide direct line management to statistical programmers, identify training needs, and optimize staff utilization. The role also involves managing the day-to-day activities of external partners in delivering program deliverables. Accountabilities Serve as the Lead Programmer and Manager of the statistical programming efforts. Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs. Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using Alexion specifications. Ensure that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit. Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team. Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary. Create and/or review programming plans, and ensure appropriate resource allocation and prioritization. Act as the primary department contact to ensure that department standards are implemented in all studies. Manage adherence to all company policies, SOPs, and other controlled documents; ensure all programming activities adhere to departmental standards. Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support. Essential Skills/Experience 7+ years statistical programming experience in the CRO or Pharmaceutical Industry. 4+ years project management experience in the CRO or Pharmaceutical Industry. Experience with CDISC SDTM and ADaM models and transforming raw data into those standards. Strong people management skills and supervisory skills gained from direct line management or supervisory experience. Proven abilities to lead and manage cross-functional projects, and people, from concept to completion. Strong verbal and written communication skills - ability to clearly and effectively present information. An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance. Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures. Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs. Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle. Advanced experience with: Constructing technical programming specifications. Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Creating all files necessary to support an electronic submission in the eCTD format. Desirable Skills/Experience BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area. Competencies: Accountability Collaboration Decision Quality Drive for Results Perseverance Problem Solving Informing Peer Relationships Time Management Building Effective Teams Managing Through Systems At AstraZeneca's Alexion division, we are driven by our passion for making a difference in the lives of patients with rare diseases. Our unique approach combines the agility of a biotech with the resources of a global biopharma leader. We foster an inclusive culture where innovation thrives, empowering our employees to grow both personally and professionally. Join us to be part of a team that is dedicated to transforming lives through groundbreaking science and compassionate care. Ready to make an impact? Apply now! Show more Show less

About The Job Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main Responsibilities The Team Lead Statistical Programmer will work with Medical Affairs biostatisticians and Sanofi Global Hub biostatistics and programming personnel to implement statistical analysis plans and provide QC’d data packages including tables, figures, and listings for use in publications (i.e., abstracts, posters, oral, presentations, and manuscripts); The Team Lead Statistical Programmer Provides leadership, guidance, and strategic inputs for all Sanofi Global Hub Programming personnel with different level of expertise through all projects of one or more TAs, and ensure their team members are current with advanced statistical programming techniques; The Team Lead Statistical Programmer will develop, implement, and document non-routine macros and advanced techniques; The Team Lead Statistical Programmer will ensure SOPs are followed and timelines and quality metrics are met; Secure delivery of high-quality of deliverables (TLFs) in time and in compliance with internal and external standards; Manage and ensure stakeholder’s expectations – ramping up programming teams and day to day operations to meet business requirements. People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product – with an objective to develop statistical data outputs. 2) Actively support to maintain interface between Medical Activities Hub and Stakeholder by facilitating regular interaction and implementing appropriate trackers. 3)Ensure continuous assistance to new team members to support efficient and quick onboarding and knowledge sharing sessions across Sanofi Global Hub. Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data. 2) Lead/contribute to the global coordination efforts to identify, develop, innovate/automate and implement departmental standards, applications, processes and trainings; participate to the evaluation of tools/applications and endorse their development. 3) Collaborate effectively with Principal biostatisticians and programmers to ensure high quality and timely statistical programming deliverables across the TAs. 4) Design, develop, test, implement, and document statistical programming in high-level software packages e.g., SAS. 5) Produce well documented data packages that include tables, listings, and figures. 6) Work closely with the Head Biostatistics and Statistical Programming, Principal Biostatisticians to develop and implement project management tools / tracker to automate the proper resource assignment & utilization, QC plans and timelines. 7) Develop and maintain statistical programming team using R / Python. Customer: 1) Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables. About You Experience: Master's degree minimum 8 years/B.Sc. minimum 10 years of relevant experience required Soft skills: Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines Technical skills: Advance SAS programming skills, SDTM & ADaM (CDISC) and clinical data environment across multiple therapeutic areas Education: Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field. Languages: Excellent English language knowledge – written and spoken Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! null Show more Show less

Description Principal Statistical 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 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, you’ll 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. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. Transfers deliverables. Performs other work-related duties as assigned. Minimal travel may be required Qualifications What we’re looking for Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. Experience in mentoring others in clinical trial process and CDISC Standards. Excellent written and verbal communication skills. Ability to read, write, speak and understand English. 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, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. 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. Show more Show less

Job Title: Statistical Programmer (R) Location: Remote About the Role: We are seeking a talented Statistical Programmer with a strong background in R programming to join our dynamic team. In this role, you will collaborate with statisticians, data managers, and clinical researchers to deliver high-quality statistical programming support for clinical trials and research studies. You will be responsible for data preparation, analysis, and the generation of statistical outputs, ensuring compliance with regulatory standards. Key Responsibilities: Develop and validate statistical programs using R to support clinical trial analysis and data visualization. Create and maintain analysis datasets, summary tables, listings, and graphical presentations. Collaborate closely with statisticians to ensure accurate and efficient data analysis. Contribute to the development of statistical analysis plans (SAP) and programming specifications. Participate in data quality checks and data review processes. Ensure compliance with regulatory guidelines (e.g., CDISC, ICH, FDA) and internal quality standards. Troubleshoot and resolve programming issues related to data processing and analysis. Document programming work for transparency and reproducibility. Qualifications: Bachelor’s or Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field. 3+ years of experience in statistical & R programming within the pharmaceutical, biotechnology, or CRO industry. Proficiency in R programming, including package development and data manipulation. Strong understanding of clinical trial data and statistical methodologies. Experience with CDISC standards (SDTM, ADaM) is a plus. Show more Show less

Job Overview Provide programming support as part of the Statistical Programming (SP) team to develop and maintain programs to meet internal and external clients’ needs. Support the development of project-related solutions to a variety of statistical programming tasks. Essential Functions Program, test, and document statistical programs for use in creating statistical tables and listing summaries. Program analysis databases (derived datasets) and transfers of data for internal and external clients. Program database quality control checks. Assist in development of programming documentation including plans and specifications, as appropriate. Assist in developing, implementing and validating new process technologies, macros and applications. Assist project lead in fulfilling project responsibilities. Education & Experience: Master’s degree in Computer Science or a related field with a minimum of 2.5 years of relevant experience, or Bachelor’s degree in Computer Science or a related field with a minimum of 3 years of relevant experience Technical Expertise: Strong knowledge of statistics, programming, and/or the clinical drug development process Proven expertise in SDTM, ADaM, and TLF standards Advanced proficiency in computing applications, including Base SAS, SAS Graph, and SAS Macro Language Skills & Competencies: Excellent organizational, interpersonal, leadership, and communication skills Ability to manage multiple tasks and projects effectively High level of accuracy and attention to detail Strong ability to establish and maintain effective working relationships with colleagues, managers, and clients IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com Show more Show less

Job Overview Responsible for study build & design, edit specifications, system configurations and is accountable for associated study design components. This role will collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, the role also would be responsible for the project financials from programming shared services perspective. Essential Functions Interprets the study protocol. Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable. Create and update Edit Specification Document. Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page) Complete the Study Authorization Form and Trial Capacity Request Form (InForm) Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal Design Review Meeting. May lead Online Screen Review Meeting. Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document. Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates. Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan. Escalate potential quality issues. Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures. Reviews build timelines and provide input as applicable. Reviews QIP for own projects, identify out of scope activities if any and inform relevant parties. Responsible for multiple study design projects at the same time. Might be working on projects across multiple platforms. Identify areas for process improvements on an ongoing basis. Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes. All responsibilities are essential job functions unless noted as nonessential (N). Qualifications Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req 2-4 years of relevant core Technical designer experience and total exp being 7+ yrs. Req IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com Show more Show less

Job Overview Responsible for study build & design, edit specifications, system configurations and is accountable for associated study design components. This role will collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, the role also would be responsible for the project financials from programming shared services perspective. Essential Functions Interprets the study protocol. Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable. Create and update Edit Specification Document. Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page) Complete the Study Authorization Form and Trial Capacity Request Form (InForm) Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal Design Review Meeting. May lead Online Screen Review Meeting. Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document. Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates. Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan. Escalate potential quality issues. Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures. Reviews build timelines and provide input as applicable. Reviews QIP for own projects, identify out of scope activities if any and inform relevant parties. Responsible for multiple study design projects at the same time. Might be working on projects across multiple platforms. Identify areas for process improvements on an ongoing basis. Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes. All responsibilities are essential job functions unless noted as nonessential (N). Qualifications Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req 2-4 years of relevant core Technical designer experience and total exp being 7+ yrs. Req IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com Show more Show less

Internal/extrernal stakeholders, project team members, vendors Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis Support the electronic submission preparation and review Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and / or performs programming assignments with minimal supervision Support improvement initiatives Minimum Requirements: Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required. At least 3 years programming experience in industry recommended. For US positions: US military experience will be considered towards industry experience. Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs. Understanding of clinical data structure (e.g. CDISC standards) and relational database. Demonstrated skills in using software tools and applications, e.g., MS office, XML. Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Demonstrated ability to work in a team environment with clinical team members. Preferred Requirments: Minimum of 3 years clinical / statistical programming experience within pharmaceutical clinical development Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements Experience in other software packages (e.g. R) Experience with the Linux operating system IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com Show more Show less

Functional consultant with SAP Configuration experience ideally in MDM (Article master), or second choice MM module (Material master) - EXPERT LEVEL Rxperience in SAP Retail (SAP vertical solution IS Retail) Person should be well versed with standard SAP Concepts of Assortment, Listing, Merchandise Category, etc. know SAP transaction MM41 (Article master) or MM01 (Material master MDM delas with lots of mass changes and some experience with LSMW, MM46, MM17, bespoke programs, or 3rd party tools like Process Runner, Innowera, etc Primary Skills Experience in MDM/ MM with IS- Retail Configration exp in MDM or MM

Key Skills: Adam, SDTM Roles and Responsibilities: Lead statistical programming activities as Trial Programmer for assigned studies or project-level activities including requirements analysis, resource estimation, planning and tracking, development of programs and validation of deliverables Develop and review programming dataset specifications Coordinate activities of all programmers assigned to the same study or project. Conduct kickoff meeting to provide an overview of the study or project, discuss deliverables, roles and responsibilities, timelines, and conventions Remove barriers to facilitate quality, timely and efficient completion of deliverables. Ensure that programmers have all required inputs for their tasks Provide solutions to programming issues and/or ensure efficient implementation Build and maintain effective working relationships with relevant team functional representation. Effectively communicate the status of deliverables, changes to plan, risks and proposed mitigation strategy to relevant team, Project Programmer and supervisor Contribute to development of SP standards and processes, knowledge sharing and other tasks as assigned Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results Skills Required: Quality and timeliness of all deliverables for assigned studies or project-level activities Ability and effectiveness in leading activities and coordinating programmers assigned to the same study or project Adequate representation as Trial Programmer in the Clinical Trial Team. Effectiveness of communication and participation as assessed by the team members Compliance with internal and external standards as measured by audit findings Works effectively under minimal supervision of supervisor or Project Programmer who is responsible for the overall statistical programming strategy for the project Timely and high quality SP deliverables. Delays and errors in deliverables may impede submissions or other product developments and subsequent revenue loss to the company Efficient programming leading to quality submissions, and reduced time and costs for development and registration Ensuring external quality reputation of Company with Health Authorities Strong SAS programming skills including development and use of macros Extensive experience in requirements analysis, resource estimation, planning and tracking deliverables and coordinating activities Extensive experience in developing programming dataset specifications Good working knowledge of statistical concepts Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, ICH) and industry standards such as CDISC Excellent written and oral communication Ability to work well with others globally Minimum Requirements: 7 years of relevant experience in clinical Statistical programming & SDTM, ADaM, Analysis dataset and specification creation, (TLF)Table and Listing creation 2 years of proven ability to lead statistical programming activities as Trial Programmer Education: BA/BS/MS degree or equivalent experience in mathematics, statistics, computer science, health sciences or related field

Job Title: Clinical Standard and Bio Stats Job Location: Pan India (Preferrable: Delhi or Mumbai) Exp Range: 10 - 18 Years Job Description: Roles and Responsibility: Contributes in building Product and solutions in Digital Data Flow, along with Product Team by providing Subject Matter expertise and knowledge on Industry Trends. Contributes to build differentiated Product offerings to maximize Sales and increase number of customers on Product. Co-leads the global strategic positioning & roadmap from a business view for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics e.g. SDTM, ADaM, Regulatory Submission Packages and Data Management (EDC, non-CRF, eDTA), TFLs, SDR, USDM (e.g. STDM, ADaM.) Co-leads the design & development for these solutions from a business view Co-leads thought leaderships and external visibility (e.g. articles, webinars, conferences, cross-industry meetings), initiates advisory boards Supports business development team with customer presentations, RFI/RFP requests and go-to-market strategy. Initiates customer leaderships connects and strategic partnerships. Description: At least 10-15 years of global drug development experience in Digital Data Flow, metadata repository, clinical data standards, biometrics, EDC, eDTA, gained preferably at top-15 pharma companies or clinical research organizations (CROs) Extensive hands-on experience with Digital Data Flow, data collection standards, biostatistical programming, STDM, ADaM, TFL and regulatory submission packages, including innovative tools and strategies for automation. Experience in applying AI in standardization, SDTM, ADaM and TFL generation. Experience in strategy setting for generating EDC build from study protocol, SDR Model, USDM Experience in innovative ways to automate testing and validation Track record of building respect and trust with customers, employees and other internal and external stakeholders and partners. Broad cross-pharma senior management network & preferably cross-industry forum expertise (e.g. CDISC, Transcelerate, IMI) Outstanding communication skills with ability to translate technology in a clear & easy-to-understand language Strong interpersonal skills including negotiation skills, facilitation skills and ability to drive for clarity and results when faced with ambiguity. Master’s degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage Show more Show less

Location : Mumbai & Chennai. Skill : SDTM, ADAM and TLF. Exp : 5+ years core experience in Clinical SAS Programming is mandatory. Jd An Individual Contributor role : Productive hands-on programming, supporting deliverables in the study/project/portfolio/standards team, of medium to high complex statistical programming deliverables to support assets and study teams. Performs tasks independently with mentorship or advise from Programming Leads within the organization. Acts as co-lead/lead on selected projects/initiatives/activities and also study deliverables as needed. Guide, mentor, monitor programmers within the team and collaborate with SDSL's on timelines, resource management and deliverables with quality. Is capable of handling standards/study programming specific activities independently including collaboration across stakeholders at various timezones. Ensures adherence to high quality programming standards in their daily work. Ensure the tasks are completed on time with quality and are compliant to the process at Pfizer with needed guidance. Work collaboratively with study teams and stakeholders such as clinicians and statisticians on milestones and deliverables. Active self-learning and delivering on solutions in the space of statistical programming and data standards. Contribute to SDSA initiatives globally and locally. Skills Bachelor or Master (preferred) Degree in Statistics, Computer Sciences, Engineering, Pharmacy, biological sciences, IT, or related field. At least 5 6 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency. Understanding of clinical data and drug development process, CDISC standards required. Statistical Programming and SAS hand-on experience. Clinical trials expertise with an understanding of data operations required for the reporting of clinical. Good understanding of ICH and regulatory guidelines. Working knowledge of clinical data and relevant data standards. Is able to work with stakeholders across timezones under tight timelines. Strong written and oral communication skills, and time and project management skills. Strong competencies and interests for innovation and problem solving. Proven ability to operate with limited oversight. Knowledge of at least 1 Therapeutic Area. (ref:hirist.tech) Show more Show less

Job Profile Summary The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects. Job Description Key Accountabilities: Project Management Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Statistical Programming For Assigned Projects Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings. Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation. Training Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas. Provide relevant training and mentorship to staff and project teams as appropriate. General Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in process/quality improvement initiatives. Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills Excellent analytical skills. Proficiency in SAS. Knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Ability to manage competing priorities and flexibility to change. Attention to detail. Ability to successfully work as part of a global team. Work effectively in a quality-focused environment. Effective time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Business/operational skills that include customer focus, commitment to quality management, and problem solving. Knowledge And Experience Competent in written and oral English. Good communication skills. Education Educated to degree level in a relevant discipline and/or equivalent work experience. Show more Show less

Role: Study Data Manager (SDM) Exp: 5+ yrs in Clinical Data Mgmt (CDM), incl. 1+ yr leading trials. Location: Mumbai/Pune/Bangalore. Reject ex-TCS, non-BPO int’l exp. Represent DM in study meetings, escalate risks, drive resolutions. Required Candidate profile Key Responsibilities: End-to-end DM ownership (study setup, eCRF design, DMP, DB locks). Lead cross-functional teams, mentor CDRs, and ensure data integrity.

Our Team About the job Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally, Main Responsibilities The Associate Biostatistician will work with Medical Affairs biostatisticians and Sanofi Business Operations biostatistics and programming personnel to support and implement statistical analysis plans and provide QCd data packages including tables, figures, and listings for use in publications (i-e abstracts, posters, oral, presentations, and manuscripts); The Associate Biostatistician will ensure SOPs are followed and timelines and quality metrics are met, People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product with an objective to develop statistical data outputs, Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data 2) Support in Design, develop, test, implement, and document statistical programming in high-level software packages e-g SAS 3) Produce well documented data packages that include tables, listings, and figures 4) Closely follow QC plans and timelines set by senior members of the Sanofi Business Operations biostatistics and programming team 5) Review appropriate biomedical and clinical research literature related to assigned project(s), Customer: 1) Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables, About You Experience: Master's degree with 1-3 years (m-sc ) of experience required /Ph D in biostatistics or statistics or epidemiology and 1-2 years, Soft skills: Ability to manage timelines and Ability to work independently and within a team environment, High proficiency in statistical methods used in the pharmaceutical industry?, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines, Technical skills: Base and / or Advance SAS programming skills, SDTM & ADaM (CDISC) and other statistical computing software skills in a clinical data environment across multiple indications in a therapeutic area, Education: Master of Science degree or equivalent in Statistics/ Ph D in biostatistics or statistics or epidemiology Languages: Excellent English language knowledge written and spoken Pursue progress, discover extraordinary Better is out there Better medications, better outcomes, better science But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen So, lets be those people, At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity, Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi ! null

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. The Principal Statistical Programmer (“Programmer”) will have experience in all required areas of a Senior Statistical Programmer. The Principal Statistical Programmer is responsible for providing statistical programming services for assigned clinical trials. This includes acting as the lead programmer for assigned clinical trials. Responsibilities Exceed expectations and responsibilities of a Senior Statistical Programmer Understand and implement CDISC and other regulatory standards Follow internal SAS programming conventions Serve as programming lead on complex clinical trials; or serve as portfolio lead across a large suite of studies for a sponsor Coordinate and ensure the accuracy and completeness of activities for assigned support programmers Create and maintain project timelines Design, develop, document and validate tools and macros to improve quality and efficiency of processes Prepare and review programming specifications for SDTM, ADaM and other derived datasets Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to: Analysis datasets (SDTM, ADaM, other derived datasets) Tables, listings and figures xml/Reviewer’s Guide Integrated summaries Perform ad hoc analyses of current and legacy databases Review and provide input on case report form design Serve as a subject matter expert Train and mentor others in task execution Proactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needs Develop department training materials and deliver trainings to the team Drive/facilitate/actively engage in department initiatives Work effectively with other programmers, statisticians, data managers, database programmers and other cross-functional team members to ensure accurate and high-quality statistical outputs Standard Operating Procedures (SOPs) Strong understanding of departmental and company procedures; ability to guide others on procedures Participate in the development and revision of department SOPs Business Development Support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc. Additional Responsibilities Assist in the preparation and review of monthly financial reporting Promote visibility outside of the functional area and effectively interact cross-functionally and in industry Participate in candidate interviews Perform other duties as requested by management Qualifications: The ideal candidate should have a degree in Statistics, Computer Science, or a closely related field; work experience may be substituted for degree Minimum of 6 years direct SAS programming experience in pharmaceutical development or CRO environment Good knowledge of medical terminology and conduct and analysis of clinical trials Knowledge of relevant industry data standards (e.g. CDISC SDTM, ADaM, etc.) Excellent oral and written communication skills, organizational skills, and attention to detail are required At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience. Equal Employment Opportunity It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law. This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available. Show more Show less

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re 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 Clinical Data Science Programmer Location : Chennai/ Bangalore What You Will Be Doing Strong SQL skills working in the clinical data management environment. In depth knowledge of Visualization Design and good understanding of end-to-end data flow in Data management. Strong technical experience with Data Management Reports and Listings such as Clean Patient Tracker, DM Metrics , coding listings etc. High attention to detail including proven ability to manage multiple, competing priorities. Experience working in a matrix environment and collaborating across functions and organizations, including demonstrated ability to influence without authority. Knowledge of GCP and other regulations. Good knowledge of CDISC, SDTM standards. Excellent written and oral communication skills. Demonstrated leadership, problem solving, conflict resolution, and team building skills. You Are Any life science graduation 5+ Years of experience must Location : Chennai/Bangalore What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve 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 family’s 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 family’s 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. We’re 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 requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Show more Show less

We are seeking a highly skilled Senior Business Analyst with expertise in the healthcare and pharmaceutical domains to join our team. This role will involve analyzing business requirements, translating them into technical specifications, and collaborating with stakeholders to design and implement healthcare IT solutions that enhance clinical workflows, data management, and regulatory compliance. Join our team to drive cutting-edge healthcare solutions that transform patient care and healthcare operations! Responsibilities Conduct stakeholder interviews to gather comprehensive business and technical requirements Assess healthcare workflows, clinical processes, and administrative practices to identify optimization opportunities Create detailed functional specifications, system design documents, and user guides for healthcare IT systems Develop process flow diagrams, wireframes, and prototypes to visualize system requirements and designs Collaborate with development teams, project managers, and UX/UI designers to ensure alignment with healthcare needs Assist in project scoping, estimation, and scheduling to ensure timely delivery of healthcare IT solutions Monitor project progress, identify risks, and facilitate the resolution of project-related issues Develop and execute comprehensive test plans and cases for functional and non-functional requirements Facilitate user acceptance testing (UAT), document feedback, and oversee issue resolution to ensure system quality Create training materials such as user manuals, video tutorials, and guides for healthcare applications Conduct training sessions for end-users and healthcare stakeholders to ensure effective system adoption Stay updated on trends in healthcare technology, data interoperability, and business analysis methodologies Recommend innovative tools and solutions to enhance the development and efficiency of healthcare systems Requirements Bachelor’s degree in Business Administration, Health Informatics, Computer Science, Information Systems, or a related field 5–12 years of experience in the IT industry, including 5+ years in a technical or business analysis role, preferably focused on healthcare IT Knowledge of EHR systems, HIE platforms, and other healthcare technologies Proficiency in SQL, database design, and healthcare data standardization Familiarity with project management tools like JIRA, Confluence, and Microsoft Project Expertise in testing tools such as Selenium, Appium, and Postman for quality assurance Understanding of FHIR standards, OMOP data models, and SDTM standards for clinical data management Experience with Symedical or comparable healthcare data management tools Proficiency in managing standardized vocabularies such as LOINC, SNOMED, and ICD Capability to work with healthcare performance assessment metrics and clinical quality measures Strong analytical thinking coupled with a problem-solving mindset Excellent verbal and written communication skills to engage diverse stakeholders Team collaboration skills to bridge business needs and technical solutions effectively High attention to detail to ensure accuracy in technical designs, documentation, and testing Flexibility to evaluate technical feasibility, system dependencies, and project scope Nice to have Professional certifications like CBAP (Certified Business Analysis Professional) or CHBA (Certified Healthcare Business Analyst) Familiarity with emerging healthcare interoperability standards and frameworks Background in working with clinical trial systems and submissions Show more Show less

Skill required: Clinical Data Services - SDTM Mapping Designation: Clinical Data Svs Associate Qualifications: BE/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 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.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D 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 – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects. A standard structure for human clinical trial data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). What are we looking for? •Adaptable and flexible •Agility for quick learning Roles and Responsibilities: •In this role you are required to solve routine problems, largely through precedent and referral to general guidelines • Your expected interactions are within your own team and direct supervisor • You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments • The decisions that you make would impact your own work • You will be an individual contributor as a part of a team, with a predetermined, focused scope of work • Please note that this role may require you to work in rotational shifts BE,Bachelor of Pharmacy,Master of Pharmacy

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Job Description: Support all programming activities required for the data analysis of the clinical trials and create standard datasets (SDTM) and analysis datasets (ADaM) and generate reports of the form Tables, Listings and Graphs are applicable. Support other documentation tasks such as Define, RGs and CRT packages as required for the reporting of clinical trials. Collaborate with other statistical colleagues and study personnel to provide input to statistical analysis plans. Assist in and/or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the data analysis plan, and conducting the actual analysis once a reporting database is created. Collaborate with data management in the planning and implementation of data quality assurance plans. Maintain proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods. Effectively justify methods selected and implement previously outlined analysis plans. Conduct peer-review of work products from statistical colleagues. Effectively utilize current technologies and available tools for conducting the clinical trial analysis. Communication of Results and Inferences Collaborate with other statistical colleagues to write reports and communicate results. Responsible for assisting in the communication of study results via regulatory submissions, and manuscripts, as well as for communicating one-on-one with key customers. Assist or respond to regulatory queries working in collaboration with other statistical colleagues. Therapeutic Area and Systems Knowledge Understand relevant disease states in order to enhance the level of customer focus and collaboration. Ensure replication of tools and systems, where applicable and stay informed of technology advances. Regulatory Compliance Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes and training. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Support all programming activities required for the data analysis of the clinical trials and create standard datasets (SDTM) and analysis datasets (ADaM) and generate reports of the form Tables, Listings and Graphs are applicable. Support other documentation tasks such as Define, RGs and CRT packages as required for the reporting of clinical trials. Collaborate with other statistical colleagues and study personnel to provide input to statistical analysis plans. Assist in and/or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the data analysis plan, and conducting the actual analysis once a reporting database is created. Collaborate with data management in the planning and implementation of data quality assurance plans. Maintain proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods. Effectively justify methods selected and implement previously outlined analysis plans. Conduct peer-review of work products from statistical colleagues. Effectively utilize current technologies and available tools for conducting the clinical trial analysis. Communication of Results and Inferences Collaborate with other statistical colleagues to write reports and communicate results. Responsible for assisting in the communication of study results via regulatory submissions, and manuscripts, as well as for communicating one-on-one with key customers. Assist or respond to regulatory queries working in collaboration with other statistical colleagues. Therapeutic Area and Systems Knowledge Understand relevant disease states in order to enhance the level of customer focus and collaboration. Ensure replication of tools and systems, where applicable and stay informed of technology advances. Regulatory Compliance Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes and training. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly

Skill required: Life Sciences (AR&D) Services - SDTM Programming Designation: Associate Qualifications: Any Graduation,BE,BTech Years of Experience: 1-3 yrs About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 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.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D 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 enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. sdtm programmer Program mapping of eCRF and external data into SDTM standards using SAS/ETL tools as applicable. What are we looking for? sdtm programmer sdtm programmer Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Any Graduation,BE,BTech Show more Show less