275 Sdtm Jobs - Page 5

6 to 8 years of relevant experience in statistical programming Minimum 3 years of hands-on experience with R programming Strong knowledge and working experience with CDISC standards: SDTM, ADaM, and TLF Exposure to efficacy analysis

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Duties/Responsibilities: Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, datasets, define.xml, SDRG, Annotated CRF) for BMS studies Serve as Study SDTM Programming lead for all regulatory submissions. Expertise in BMS SDTM automation tools, macros and using them for SDTM programming. Identify any inefficiencies and work with experts in up-versioning/enhancing existing tools and macros. Thorough knowledge of CDISC standards including CDASH/SDTM/ADaM and keep abreast of latest updates in the industry. Design/implement the SDTM specification as per the CDISC SDTM IG and ensure they meet downstream ADaM and Reporting requirements. Work with standards team to design mapping algorithms for new items. Provide input to the design of the clinical trial database from an SDTM perspective. Annotate CRFs and Review annotated CRFs in accordance with BMS guidelines and appropriate metadata to reflect tabulation datasets. Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and BMS Quality tools to ensure regulatory compliance. Provide common language for repeated unresolvable validation issues across projects within a compound for inclusion in SDRG. Collaborate with stakeholders and Study team members to manage study timelines and resolve issues. Represent SDTM Programming function in Study team meetings as well as cross-functional working groups. Support and identify areas for automation & innovation as process enhancements to improve quality of work and efficiencies. Provide oversight of CRO/vendor programming activities to ensure adherence of standards as well as receiving quality and timely deliverables. Participate in study/project team meetings as a core member and provide technical expertise/support. Qualifications: BA/BS in a relevant scientific discipline with more than 8 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with expertise in CDSIC/SDTM. Significant knowledge of SAS software and general computing as relates to clinical drug development. Knowledge of the drug development process, clinical trial methodology, CDISC Standards and familiarity with global regulatory requirements Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals Ability to be flexible and adapt quickly to the changing needs of the organization Ability to organize multiple work assignments and establish priorities If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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: Manager, Clinical Systems Location : Bangalore Foster a culture of continuous improvement by streamlining processes and adding value across the business Ensure high-quality work compliant with GCP, ICH guidelines, and all applicable regulations Oversee administrative activities such as time-sheets, training (iLearn and sponsor-specific), and leave management for the team Manage and support local and global Clinical Systems teams to meet project timelines and budgets Liaise with project/study teams, ensuring timely communication and escalation of issues Drive effective resource allocation and workload balancing with Team Leaders and Study Leads Forecast resource needs and support recruitment efforts Mentor and guide team members by providing technical and leadership support Represent Clinical systems in audits, sponsor meetings, and cross-functional presentations Identify gaps in processes and suggest improvements proactively Conduct performance appraisals and define development plans for team members Bachelor’s or Master’s degree in Life Sciences or a related discipline Minimum of 13+ years of experience in Clinical Systems,Analytics Preferred hands-on experience with one or more Clinical Systems such as Rave, Central designer Veeva and Elluminate, exposure to data visualization, Python, and data analytics tools is also highly desirable. Knowledge on SDTM and SAS would be an advantage. Prior experience in managing or colloborating with cross functional teams ( Internal and Client facing) and ability to operate under matrix operations structure. Desire for continous learining and driving innovative solutions. Strong understanding of regulatory requirements (GCP, ICH, FDA, etc.) Representation and contribution in Industy conferences and engagments is preferred. 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.

Statistical Programmer – R Programmer (Remote opportunity) Location: Remote (India) Experience: 6 to 10 years About the Role: We are hiring a Statistical Programmer with strong R programming experience to join our growing team. This is a remote opportunity tailored for professionals passionate about clinical data analysis and programming, with expertise in CDISC standards. Key Responsibilities: Develop, validate, and maintain SDTM, ADaM datasets, and TLFs as per CDISC guidelines Perform efficacy analyses using R programming Work independently on studies and support clinical trial submissions Collaborate with cross-functional teams in an FSP environment Debug and utilize standard macros efficiently Preferred involvement in integrated summaries (ISS/ISE) Must-Have Skills: 6 to 8 years of relevant experience in statistical programming Minimum 3 years of hands-on experience with R programming Strong knowledge and working experience with CDISC standards: SDTM, ADaM, and TLF Exposure to efficacy analysis Study-level handling experience (for senior-level profiles) Preferred Skills: Experience with CRT package (Trial Data Domain) Prior involvement in ISS and ISE Experience in an FSP environment Familiarity with standard macro debugging and utilization Why Join Us? 100% Remote Role Be part of a specialized Data Science and Clinical Programming team Opportunity to work on impactful global healthcare projects

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are looking for a skilled Statistical Programmer with at least 2 years of experience to write code for the collection, analysis, and presentation of data in various research and business projects. Key Responsibilities:. Write and optimize statistical code for data analysis and model development. Implement statistical methods for clinical trials, research, and business insights. Work with large datasets, ensuring the data is accurate, clean, and well-organized. Required Qualifications:. 2+ years of experience in statistical programming. Proficiency in statistical programming languages like SAS, R, or Python. Experience in data visualization and reporting using tools such as Tableau or Power BI. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are looking for a skilled Statistical Programmer with at least 2 years of experience to write code for the collection, analysis, and presentation of data in various research and business projects. Key Responsibilities:. Write and optimize statistical code for data analysis and model development. Implement statistical methods for clinical trials, research, and business insights. Work with large datasets, ensuring the data is accurate, clean, and well-organized. Required Qualifications:. 2+ years of experience in statistical programming. Proficiency in statistical programming languages like SAS, R, or Python. Experience in data visualization and reporting using tools such as Tableau or Power BI. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are looking for a skilled Statistical Programmer with at least 2 years of experience to write code for the collection, analysis, and presentation of data in various research and business projects. Key Responsibilities:. Write and optimize statistical code for data analysis and model development. Implement statistical methods for clinical trials, research, and business insights. Work with large datasets, ensuring the data is accurate, clean, and well-organized. Required Qualifications:. 2+ years of experience in statistical programming. Proficiency in statistical programming languages like SAS, R, or Python. Experience in data visualization and reporting using tools such as Tableau or Power BI. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are looking for a skilled Statistical Programmer with at least 2 years of experience to write code for the collection, analysis, and presentation of data in various research and business projects. Key Responsibilities:. Write and optimize statistical code for data analysis and model development. Implement statistical methods for clinical trials, research, and business insights. Work with large datasets, ensuring the data is accurate, clean, and well-organized. Required Qualifications:. 2+ years of experience in statistical programming. Proficiency in statistical programming languages like SAS, R, or Python. Experience in data visualization and reporting using tools such as Tableau or Power BI. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

Hiring Alert: SDTM Programmer with 6+ years of experience! Prefer early joiners for a remote opportunity in India. Salary Expectation - NO Bar Work from home - India SDTM Mapping

External Job Description Job title: Senior Data Management Programmer Location: Hyderabad, India About the job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Join our Hyderabad Hub, build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Senior Data Management Programmer within our Hyderabad Hub, you’ll be responsible for developing program for data validation, data review and protocol deviation deliverables for assigned projects, providing timely support to Study Team(s) on data management programming or data visualization analytics according to project data cleaning strategies through project milestones from study start-up to database lock. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main responsibilities: Developing listings, summary tables, figures and/or advanced analytics for data validation, data review, medical review, AE dedicated review and SAE reconciliation Distributing and/or deploying data review and data validation solutions which are checking all collected data including external data (i.e., cross-panel checks and internal/external data reconciliation) Developing automatic protocol deviations identification solutions Liaising with standard Data Reporting Analyst (DRA) to continuously maintain and optimize the existing standard reporting tools, programs and report library. Developing efficient Power BI, Spotfire, R/Shiny & SAS standard packages facilitating the programming of study solutions Managing the technical writing at CTT level (i.e., user guides, detailed specifications, best practices, programming conventions, etc.) Analysing new requirements from customer and propose technical solution strategies. About you Experience : At least 4 years’ SAS programming experience, or have other equivalent programming language experience such as R/R shiny, Python, or have equivalent data visualization tools experience such as Spotfire, Power BI, Tableau In addition, clinical trial experience, clinical data management experience and pharmaceutical industry experience are preferred. Soft and technical skills : Advanced project management skill Advanced collaboration and communication skill Outstanding capability of independent thinking and delivery of accurate outcomes. Meeting management skill such as organize meeting and discussion Crystal clear logical thinking. Intercultural skills with ability to work effectively in a multi-cultural context. Advanced expertise in programming language such as SAS, R, Python. Advanced expertise in database structure and data flow Strong knowledge of industry standards and practices (e.g. CDISC especially CDASH and SDTM). Knowledge of data visualization tools such as Spotfire, Power BI, Tableau. Experience in implementing and fine-tuning AI/ML model Strong knowledge of current regulatory guidelines, and GCP practices regarding Data Management. Understanding of advanced drug development concepts such as Decentralized Clinical Trials (DCT), Master & Adaptive Protocols, eSource and AI Based automations is a plus Education : Bachelor or Master of Science degree or above, preferably in a life science or mathematics-related area (e.g., Pharmaceutical, medical, or mathematics, computer science or similar technical fields). Languages : Strong English skills (verbal and written), ability to exchange fluently in a global environment. Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Join an international innovative biopharma company. Lead data management programming activities and serve as an expert working on several therapeutic areas. Participate in the evolution of Clinical Data Management and deployment of innovations “As a senior data management programmer in our India Hub, you’ll get the opportunity to lead data management programming for global studies in different therapeutic areas and act as the data management programming expert to develop your career in the global organization. Join the Best, Be the Best!”

Job Job TitleKey Account Executive - E-Commerce Company NameTitan Job TypeRegular/ Job CategoryOther DepartmentE-Commerce LocationBengaluru, Karnataka, India Titan, a leading retail company in India, is seeking a highly motivated and experienced Key Account Executive to join our E-Commerce team in Bengaluru. As a Key Account Executive, you will be responsible for managing and growing our key accounts in the E-Commerce sector. Growth Primary/ Retail Sales 1) Meeting the monthly primary/ retail sales target of designated platforms. 2) Ensuring growth in sales Value YoY by planning necessary marketing activities and understanding the category trend. 3) Preparing the monthly Inventory range plan in association with merchandiser based on ROS & New Product launch 4) Timely Co-ordination with Supply chain, CFAs and Platforms for entire order fulfilment lifecycle. 5) 95%+ of range plan is live at any time. Value Creation Debtors, Payouts & Compliance 1. No over dues for the review period -Sending Reminders to partner on overdue/outstanding. Collecting sales data for credit note working. 2. All payouts should be in the budgeted limits 3. Timely Communication to internal stakeholder & associates Customer/ Stakeholder Satisfaction Partner Management 1) Healthy working relationship with internal and external stakeholders 2) Periodic business review meet with all partners (Internal & External) 3) Listing of the new products with correct information on the platforms 4) Resolving partners disputes in coordination with internal stake holders. 5) Uploading the schemes/ discounts as per the planned schemes. Innovation New Process and Initiative 100% listing of active line on the platforms Continuous replenishment for Top Sellers for partner with a Fill rate of at least 75% 10% contribution of NP on a overall target. Work Experience Education QualificationsGraduation ExperienceMinimum 1 year experience in a consumer goods company (Fashion, Electronics, FMCG) or retailers ( Flipkart/ Myntra/Amazon/ Shoppers Stop/ Lifestyle/ DMart ) \u2013 working in a sales / operations role Skills: MS Excel and data management Written & Spoken skills stake holder management Communication skills.

Skills: SDTM, ADAM, TLF & Immunology Position Summary The Manager of Biostatistics is a member of cross-functional study/project teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. These individuals develop collaborative relationships and work effectively with the Biostatistics Lead, and other cross functional team members. Key Responsibilities Contributes to designing clinical trials to address study hypotheses and objectives. Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications, and other study level specification documents under supervision. Performs and/or validates preplanned or ad hoc statistical analyses with guidance as needed. Presents & interprets results to GBDS and/or cross-functional team members. Translates scientific questions into statistical terms and statistical concepts into layman terms. Compliant with processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable. Continually develops technical knowledge of statistical methodology and how it is appropriately applied in trial design and data analysis for clear, concise, high-quality results. Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS. Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner. Qualifications & Experience MS in statistics, or biostatistics or related scientific field with 1-2 years’ experience in clinical trials, drug development, pharmaceutical industry or healthcare experience (including internship) preferred. Proficiency in scientific computing/programming (SAS, R or Python) and implementation of statistical analysis, data manipulation, graphing & simulation. Good interpersonal, communication, writing and organizational skills Ability to: learn regulatory requirements & clinical trial design, data analysis and interpretation, work successfully within cross-functional teams, organize multiple work assignments and establish priorities

Skill required: Life Sciences (AR&D) Services - SDTM Programming Designation: Associate Qualifications: Any Graduation,BE,BTech Years of Experience: 1-3 yrs About Accenture 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 worlds 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. 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 worlds 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 programmerProgram mapping of eCRF and external data into SDTM standards using SAS/ETL tools as applicable. What are we looking for sdtm programmersdtm 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 Qualification Any Graduation,BE,BTech

Job Overview Provide advanced technical expertise to develop and maintain programs to meet internal and external clients needs. Plan and lead the development of project-related solutions to the full scope of statistical programming tasks. Provide technical expertise to the Statistical Programming department. Essential Functions • Perform and plan: (i) the programming, testing, and documentation of programs for use in creating statistical tables, figures and listing summaries, (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients. May perform and plan the programming of database quality control checks. • Program the integration of databases from multiple studies or sources. • Develop programming documentation including plans and specifications, as appropriate. • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to teams and department. • Perform and plan the development, implementation and validation of new process technologies, macros and applications. • Fulfill project responsibilities at the level of statistical team lead for single studies, under supervision. • Understand the Scope of Work, estimate the work completed, and manage Out of Scope for single studies. May manage budget and resource requirements and provide revenue and resource forecasts for single studies. May be required to understand budget and quote assumptions. • Provide training and guidance to lower level and new staff. Qualifications • Master's Degree Computer science or related field and 1 year relevant experience Req Or • Bachelor's Degree Computer science or related field and 2 years relevant experience Req • Equivalent combination of education, training and experience Req • Knowledge of statistics, programming and/or clinical drug development process • Working knowledge of computing applications such as Base SAS, SAS/STAT and SAS Macro Language • Good organizational, interpersonal, leadership and communication skills • Ability to effectively handle multiple tasks and projects • Excellent accuracy and attention to detail • Ability to establish and maintain effective working relationships with coworkers, managers and clients

Location Bengaluru, Karnataka, India Job ID R-228434 Date posted 24/06/2025 Job Title: Principal Statistical Programmer Introduction to role: Are you ready to make a significant impact in the world of biopharmaceuticals? As a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the analysis of efficacy data through Tables, Listings, and Figures (TLFs). You'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you'll integrate statistical concepts with SAS Programming efficiently and optimally. Accountabilities: 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. Build and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP. Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications. Supervise/manage external vendors and contract programmers. Be responsible for progress of programming activities. Review, maintain, and approve protocol-specific documents as vital. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact to ensure implementation of department standards in all studies. Contribute ideas towards the optimization of standard operating procedures. Lead team meetings when appropriate. Engage in any other activities as required. Essential Skills/Experience: Bachelor’s Degree (Minimum) or Master’s Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Desirable Skills/Experience: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca's Alexion division, you'll find a unique opportunity to work in a company where 'Here it means more' is an ethos that drives us. Our pioneering spirit in R&D and healthcare sets us apart, allowing you to grow and innovate within a rapidly expanding portfolio. You'll be part of an energizing culture that fosters connections, exploration of new ideas, and learning. As a member of our team, you'll meet the needs of under-served patients worldwide while being empowered with tailored development programs. Our dedication to diversity, innovation, and connection to patients' lived experiences ensures your career journey is impactful. Ready to make a difference? Join us at AstraZeneca's Alexion division today! Date Posted 25-Jun-2025 Closing Date 29-Jun-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify. ]]>

Location Bengaluru, Karnataka, India Job ID R-227889 Date posted 24/06/2025 Job Title: Principal Programmer - Statistical Programming Introduction to role: Are you ready to take on a pivotal role in statistical programming? As a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the creation of Tables, Listings, and Figures for efficacy data analysis, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. You'll lead programming efforts, represent Clinical and Statistical Programming in meetings, and mentor fellow programmers. This is your chance to integrate statistical concepts with SAS Programming efficiently and effectively! Accountabilities: 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 based on Protocol SAP. Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications. Supervise/manage external vendors and contract programmers. Oversee progress of programming activities. Review, maintain, and approve protocol-specific documents as necessary. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies. Contribute ideas and thoughts towards the optimization of standard operating procedures. Lead team meetings when appropriate. Any other activities as required. Essential Skills/Experience: Bachelor’s Degree (Minimum) or Master’s Degree (Preferred) in Biostatistics, Statistics or another related discipline Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Knowledge of: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca, we play an essential role in helping patients who need it the most. Our high exposure roles allow us to shape end deliverables while embracing global opportunities across all Therapy Areas. With a restless drive for improvement, we foster an inspiring learning environment where every setback is a chance to innovate. Our courageous team speaks up, shares opinions, and makes bold decisions that could change patients' lives. We combine specialist knowledge with curiosity, always searching for better ways to achieve the best results. Here, dedication and motivation are key as we navigate unknowns with resilience. Ready to make an impact? Apply now to join our dynamic team! Date Posted 25-Jun-2025 Closing Date 29-Jun-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify. ]]>

As a Statistical Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Skills required: define.xml, P21, SDRG, ADRG What You Will Be Doing The role is part of the Submissions Center of Exellence Will need to keep informed of the latest regulatory requirements The programming of SDTM datasets, ADaM datasets, and TFLs will still be the responsibility of the trial clinical/statistical programmer Qualifications Previous experience submitting data to regulatory authorities is preferred Will take on the post-database lock activities related to making SDTM and ADaM data packages submission-ready (per latest requirements) Resizing datasets, removing empty variables etc. Generating Define.pdf o Final P21E run Verifying all explanations are correct in the cSDRG/ADRG o Bookmarking and setting correct properties for PDF documents, etc. 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, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. 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.

Essential Functions: • Perform, plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients and (iii) the programming quality control checks for the source data and report the data issues periodically. • Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies. • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies. • Fulfill project responsibilities at the level of technical team lead for single complex studies or group of studies. • Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines. • Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables. • Use and promote the use of established standards, SOP and best practices. • Provide training and mentoring to SP team members and Statistical Programming department staff. Qualifications: • Bachelor's Degree Maths, Computer science, Statistics or related field and 10 years relevant experience Req Or • Master's Degree Maths, Computer science, Statistics or related field and 12 years relevant experience Pref • Typically requires 7+ years of prior relevant experience • Equivalent combination of education, training and experience in lieu of degree • Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience. • Advanced knowledge of statistics, programming and/or clinical drug development process; • Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro Language, where applicable • Excellent organizational, interpersonal, leadership and communication skills • Excellent accuracy and attention to detail • Aptitude for mathematical calculations and problem solving • Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM) • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities: Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable): Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results. Skills, knowledge, and experience Minimum Requirements: Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Preferred Requirements: Management experience supervising technical professionals If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Sponsor-dedicated JOB DESCRIPTION Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values We believe in applying scientific rigor to reveal the full promise inherent in data. We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. We prize innovation and seek intelligent solutions using leading-edge technology. Responsibilities How you will contribute: Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs) Production and QC / validation programming Generating complex ad-hoc reports utilizing raw data Applying strong understanding/experience of Efficacy analysis Creating and reviewing submission documents and eCRTs Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries Performing lead duties when called upon Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. Being adaptable and flexible when priorities change Qualifications Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc. At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above. Study lead experience, preferably juggling multiple projects simultaneously preferred. Strong SAS data manipulation, analysis and reporting skills. Solid experience implementing the latest CDISC SDTM / ADaM standards. Strong QC / validation skills. Good ad-hoc reporting skills. Proficiency in Efficacy analysis. Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data. Submissions experience utilizing define.xml and other submission documents. Experience supporting immunology, respiratory or oncology studies would be a plus. Excellent analytical & troubleshooting skills. Ability to provide quality output and deliverables, in adherence with challenging timelines. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Key Responsibilities Project Responsibilities Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable) Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results. Skills, knowledge, and experience Minimum Requirements Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Preferred Requirements Management experience supervising technical professionals If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Description. Principal Stat 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 definesall 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 programmingdeliverables.. 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. 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.. 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.. Show more Show less

Description Sr Statistical Programmer SDTM, ADAM & TLFs 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 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 and sponsor requirements Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines allvariables to be accepted by peer review and sponsor/requestor with little rework, Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others, 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, Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted, 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, Transfers deliverables, Performs other work-related duties as assigned, Minimal travel may be required Qualifications Should have an experience of 5+ years in Clinical Statistical programming with expertise in end-to-end programming (SDTM, ADAM & TLGs), 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, 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, 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://syneoshealth, 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,

Description Sr Stat Programmer (SDTM + ADAMs + TLF) 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 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 definesall 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 programmingdeliverables, 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 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, 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://syneoshealth, 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

Title - Associate Director - Data Product Manager GCL- E Typical Accountabilities: The role holder will execute the following accountabilities autonomously with limited supervisory oversight: Works with consumers / business users on the definition of the data requirements for intended data solutions. Able to translate unstructured, complex business problems into a data design and solution Profiling of data to understand provenance, quality, metadata models, ownership and compliance to internal and external regulatory standards Ad hoc wrangling of data (sourcing, extraction, profiling, integration) to support Data Science model generation and business insight Support of data engineers in the development of Source to Target pipelines (e.g. ETL design) Design & testing of the quality and performance of derivative data models in reporting and analytics solutions Processing of requests for compliant access to data Defining and managing information lifecycle management in data solutions Provision of data understanding (structure, provenance, quality) to Architects, Data Engineers and Data Scientists to support use in Analytics projects. Supports IT and business data teams in identifying and managing Critical Data Assets and Elements including Reference, Master and Metadata. Collaborates with Risk, Assurance, Privacy, Information Security and Regulatory authorities to ensure data and information controls are in place and adhered to. Clearly and objectively communicate insights and results, as well as their associated uncertainties and limitations Guidance of junior Data Analysts – supervision of task completion, support in trouble shooting challenges and contributing to performance evaluation reports Sharing of insight and best practice in community forums supporting capability development. Personal development and training in more complex data analysis skills, techniques and tooling Provision of domain data expertise (data standards, systems, metadata models, policies, business processes) in at least 1 domain area (e.g. chemistry, finance) and will be developing expertise in further domains Working with senior personnel they will contribute to Development of best practice for Data Analysis: Methods and Technology: technology evaluation, POCs Provision of training and skill development in the best practice of Data Analysis: training materials, FAQs, Playbooks and integrated operating models. 3 key specialisms include: Source Data Analysts: Support engineers build/configure source applications by defining the data requirements and modeling the appropriate data structures for given use cases. They define data quality criteria to ensure data quality integrity of the application, develop logical data models (compliant to any RMDM standards), ensure that the project deliverable aligns with the logical design and business requirements (requirements traceability). Integration Data Analyst: Support engineers build composite analytics applications by defining data requirements, data structures and data integration paths. They will identify, profile and quality assess potential source data sets, understand and comply with any data restrictions (e.g. GDPR, License, IDAP controls, etc), develop integration patterns (ETL design), support the design of target data models (compliant to any MDM standards) and document to support re-use and management of the application. Data Steward: defining and managing data governance policies, standard and operating processes; the facilitation and operation of data and information governance activities; data quality issue management; the establishment and operation of governance controls including data access, lifecycle and metadata management; risk based approach to remediation and mitigation planning. Typical People Management Responsibility (direct / indirect reports): Approximate number of people managed in total (all levels) - 2-3 Manager of a team Matrix Manager – (projects/dotted line) Education, Qualifications, Skills and Experience: Essential: Undergraduate degree in a Computer Science, Data Management or possibly discipline area (R&D, Finance, HR etc) and cross trained or equivalent number of years of experience; Proven experience in a data analyst or business role aligned to data and information management role with practical examples of performing data analysis in terms of defining requirements, gleaning critical data elements, defining data quality criteria and checkpoints; Domain data understanding: the structure, provenance and meaning of the source data crucial to the domain (eg. SAP for Finance, SDTM for Clinical). Understanding of the business processes in the generation and consumption of data Desirable: Post-graduate degree in MIS, Data Management Skills and Capabilities: Essential: The role holder will possess a blend of data requirement analysis, data quality analysis, data stewardship skills; Experience in translating requirements into fit for purpose data models, data processing designs and data profile reports Experience in the use of data modeling technologies; Experience in working in multi-skilled, multi-location data teams, working to agile principles.; Knowledge of key AZ policies and standards for data covering areas such as privacy and security.; Excellent written and verbal communication, and consultancy skills; Awareness of the end to end processes and activities in the build and support of Data solutions; Experienced in applying a risk based methodology to data and information management; Experience in the use of metadata cataloguing tools; Experience of Data Analysis enabling tool kits Desirable: Leading the work of others – task setting, supervision and coaching of more junior staff Key Relationship to reach solutions: Internal (to AZ or team): Working with peers and team leaders in the business and IT in the delivery of data capabilities; Junior data analysts in supervising delivery; Data engineering teams to deliver data structures and data provisioning processes; Data Science teams supporting ad hoc data access and provision; Key assurance teams including Risk, Privacy Information security and audit; Other data analysts across AZ to develop and extend data analysis approaches and best practices External (to AZ): Outsource partners to deliver and support data structures and data provisioning processes