178 Sdtm Jobs

Novo Nordisk Global Business Services ( GBS) India Department - Global Data & Artificial lntelligence Are you passionate about building scalable data pipelines and optimising data workflowsDo you want to work at the forefront of data engineering, collaborating with cross-functional teams to drive innovationIf so, we are looking for a talented Data Engineer to join our Global Data & AI team at Novo Nordisk. Read on and apply today for a life-changing career! The Position As a Senior Data Engineer, you will play a key role in designing, developing, and main-taining data pipelines and integration solutions to support analytics, Artificial Intelligence workflows, and business intelligence. It includes: Design, implement, and maintain scalable data pipelines and integration solutions aligned with the overall data architecture and strategy. Implement data transformation workflows using modern ETL/ELT approaches while establishing best practices for data engineering, including testing methodologies and documentation. Optimize data workflows by harmonizing and securely transferring data across systems, while collaborating with stakeholders to deliver high-performance solutions for analytics and Artificial Intelligence. Monitoring and maintaining data systems to ensure their reliability. Support data governance by ensuring data quality and consistency, while contributing to architectural decisions shaping the data platform's future. Mentoring junior engineers and fostering a culture of engineering excellence. Qualifications Bachelor’s or master’s degree in computer science, Software Development, Engineering. Possess over 10 years of overall professional experience, including more than 4 years of specialized expertise in data engineering. Experience in developing production-grade data pipelines using Python, Data-bricks and Azure cloud, with a strong foundation in software engineering principles. Experience in the clinical data domain, with knowledge of standards such as CDISC SDTM and ADaM (Good to have). Experience working in a regulated industry (Good to have). About the department You will be part of the Global Data & AI team. Our department is globally distributed and has for mission to harness the power of Data and Artificial Intelligence, integrating it seamlessly into the fabric of Novo Nordisk's operations. We serve as the vital link, weaving together the realms of Data and Artificial Intelligence throughout the whole organi-zation, empowering Novo Nordisk to realize its strategic ambitions through our pivotal initiatives. The atmosphere is fast-paced and dynamic, with a strong focus on collaboration and innovation. We work closely with various business domains to create actionable insights and drive commercial excellence.

Job Title: Clinical Data Management Developer Experience: 4+ Years Location: Remote Work Hours: 9:00 AM – 6:00 PM IST Contract Type: Short-Term Contract Position Overview We are actively seeking a talented and experienced Clinical Data Management Developer with a strong foundation in Python programming and Electronic Data Capture ( EDC ) systems to support critical clinical research and data operations. This role is ideal for professionals who are passionate about improving the quality and integrity of clinical trial data through innovative technology and clean, reliable code. The successful candidate will have practical experience in tools such as MedDataRave and Inform , and demonstrate a deep understanding of clinical trial data standards like SDTM and CDISC . Your work will directly support regulatory submissions, data transformation, and analytics across a wide variety of clinical studies. Key Responsibilities Develop and maintain automated data pipelines and data transformation scripts using Python in a clinical research context. Integrate data across multiple EDC platforms such as MedDataRave and Inform . Ensure data quality, consistency, and compliance through the application of SDTM and CDISC standards. Perform data cleaning , validation, and mapping in line with regulatory and clinical protocols. Collaborate with biostatisticians, data managers, and clinical operations teams to support data lifecycle activities. Support the development of SaaS-based tools and platforms for clinical data management and reporting. Troubleshoot and resolve data issues and discrepancies with a problem-solving mindset. Contribute to regulatory submission readiness , audit support, and documentation. Participate in design and optimization of CRFs and clinical workflows. Show more Show less

Premier Research is looking for a Principal Biostatistical Programmer to join our Biostatistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. This role will be specifically working in our end-to-end team therefore SDTM, ADaM and TLF experience is required. What You'll Be Doing Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells Performs quality control (source code review, double-programming and log review) of SAS programs Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications Prepares specifications for CDISC and other analysis data sets Assists Data Management with SAS programming needs Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team Develops and validates general SAS macros What We Are Searching For BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role 6-8 years of experience in SAS programming within the area of clinical trials. Prior experience using computerized information systems preferred. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms. Show more Show less

Job Title : Senior Statistical Programmer Experience : 7+ years Location : Across INDIA Job Overview At a team/site/staff level, provide advanced technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. 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 • Master's or Bachelor’s Degree Math’s, Computer science, Statistics • 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 Show more Show less

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Your Role As a Senior Principal Statistical Programmer, you will have the opportunity to work with advanced technical solutions such as R, Shiny, and SAS, allowing you to lead asset teams and mentor junior staff effectively. In this role, you will contribute to global assets across a variety of therapeutic areas, shaping strategic decisions in statistical programming. Your responsibilities will include leading the trial or asset programming team as the Lead Statistical Programmer, ensuring that asset and trial delivery aligns with established timelines and quality standards. You will perform programming activities at both trial and asset levels, including the development of SDTM and ADaM datasets and the creation of specifications. Additionally, you will develop and validate analytical outputs in accordance with the Statistical Analysis Plan and create datasets for integrated analyses like ISS or ISE. You will also be responsible for executing ad-hoc programming activities based on internal and external requests. Actively contributing to statistical programming initiatives, you will support process improvements and innovation while providing expert advice, guidance, and training to trial and asset teams, fostering the development of your colleagues' skills. Who Are You BSc or MSc (in a numerate discipline preferably in Mathematics, Statistics or Computer Science) Proven success in a Statistical Programming role within clinical development at a pharmaceutical or biotech company, or at a CRO, equivalent to a minimum of 9 years directly relevant experience. Experience in an international environment is a plus. Advanced skills in R and SAS Full familiarity of CDISC SDTM and ADaM standards (including specifications, Define.xml, and reviewers guide) and underlying concepts. Strong understanding of processes related to clinical development programs, Experience in leading e-submission processes is beneficial. Demonstrated ability to manage assets effectively, ensuring timely delivery and quality outcomes Ability to provide solutions for complex programming challenges and evaluate alternatives to identify optimal solutions. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team! #StatisticalProgramming #SAS #DataScience #DataAnalysis #ProgrammingJobs Show more Show less

Summary The Senior Principal Programmer is responsible for all statistical programming aspects of several studies, a medium to large sized project or project-level activities (incl. submission and postmarketing activities) The position is a key collaborator and strategic partner with biostatistics in ensuring that pharmaceutical drug-development plans in Novartis Global Drug Development are executed efficiently with timely and high-quality deliverables. About The Role Major accountabilities: 1. Lead statistical programming activities as Trial Programmer for several studies or as a Lead/ Program Programmer for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization. 2. Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at study or project level. 3. May act as functional manager for local associates including providing supervision and advice to these programmers on functional expertise and processes. 4. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as SP representative in study- or project-level team. 5. Review eCRF, discuss data structures and review activities, ensure project-level standardization which allows pooling and efficient CRT production. 6. Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. CSPD and other project-level strategies). 7. Provide and implement statistical programming solutions; ensure knowledge sharing. Act as programming expert in problem-solving aspects. 8. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project. 9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. 10. Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. 11. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance 12. Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures. Key Performance Indicators 1. Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers. 2. Adequate representation of the Statistical Programming function as Trial/Lead/Program Programmer in the Clinical Trial Team/ project level meetings. Effectiveness of communication and team behaviors as assessed by the team members. 3. Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study/project as assessed by the functional/operational manager. 4. Ability and effectiveness as a programming representative on non-clinical initiatives. Ideal Background (State the preferred education and experience level) Education (minimum/desirable): BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Languages: Fluent English (oral and written). Experience/Professional Requirement Expert SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables, proven experience in development of advanced MACROs Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures) Proven communications and negotiation skills, ability to work well with others globally and influence Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/project, ability to transfer own knowledge to others Ideally 7+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Our Team Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main Responsibilities The Associate Statistical Programmer will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans and provide QC’d data packages including tables, figures, and listings for use in publications (i.e. abstracts, posters, oral, presentations, manuscripts, and ad-hoc data analysis requests) ; The Associate Statistical Programmer will assist in developing, implementing of programming techniques. The Associate Statistical Programmer will ensure SOPs are followed and that timelines and quality standards are met. People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and/or programming team members within the allocated Global business unit and product – with an objective to develop statistical data outputs. Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data and/or registry. 2) Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS. 3) Produce well documented data packages that include tables, listings, and figures. 4) Closely follow QC plans and timelines set by senior members of the Sanofi Business Operations biostatistics and programming team. 5) Remain current on advanced programming methods Customer: 1) Work closely with Global Medical Affairs biostatisticians and/or programmers to identify statistical analysis needs and assist in developing assigned deliverables. About You Experience: B.Sc. or Master's degree minimum 1 years of relevant experience required, or a minimum of 6 months of relevant internship experience. Soft skills: Ability to manage timelines and Ability to work independently and within a team environment. Technical skills: Base SAS programming skills, basic knowledge SDTM & ADaM (CDISC) Education: Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field. Languages: Excellent English language knowledge – written and spoken Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! null Show more Show less

Our Team: Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: The Associate Statistical Programmer will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans and provide QC’d data packages including tables, figures, and listings for use in publications (i.e. abstracts, posters, oral, presentations, manuscripts, and ad-hoc data analysis requests) ; The Associate Statistical Programmer will assist in developing, implementing of programming techniques. The Associate Statistical Programmer will ensure SOPs are followed and that timelines and quality standards are met. People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and/or programming team members within the allocated Global business unit and product – with an objective to develop statistical data outputs. Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data and/or registry. 2) Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS. 3) Produce well documented data packages that include tables, listings, and figures. 4) Closely follow QC plans and timelines set by senior members of the Sanofi Business Operations biostatistics and programming team. 5) Remain current on advanced programming methods Customer: 1) Work closely with Global Medical Affairs biostatisticians and/or programmers to identify statistical analysis needs and assist in developing assigned deliverables. About you Experience : B.Sc. or Master's degree minimum 1 years of relevant experience required, or a minimum of 6 months of relevant internship experience. Soft skills : Ability to manage timelines and Ability to work independently and within a team environment. Technical skills : Base SAS programming skills, basic knowledge SDTM & ADaM (CDISC) Education : Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field. Languages : Excellent English language knowledge – written and spoken Pursue Progress, discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Create and/ or review derive data specifications as per the standards for SDTM, ADaM datasets and pooled analysis (ISS/ISE) datasets Perform development and validation of analysis dataset, tables, listings and figures for both safety and efficacy parameters Understand and comply with ICH-GCP guidelines, core operating procedures and work instructions. Ensure all programs are compliant with the SOPs and project specific guidelines Provide support in developing ad hoc reports as required Maintain quality and timelines of programming related deliverables Update project related documentation regularly Track and follow up on all issues raised. Experience with R Programming/ Python Show more Show less

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. Show more Show less

Company Description ClinFocus empowers life sciences organizations to accelerate clinical trials through technology-driven solutions. Our services include EDC Development, Systems Integration, AI Deployment & Enablement, Clinical Data Science, Project Management, and Development of Integrated Dashboards. As an ISO-certified organization and partner of Medidata Rave, we are committed to excellence and trust in clinical research. We are seeking a highly motivated and skilled Clinical Statistical Programmer to join our dynamic Biometrics team. In this role, you will be instrumental in the development, validation, and maintenance of programs used for the analysis and reporting of clinical trial data. You will work closely with biostatisticians, data managers, and clinical scientists to ensure the accurate and timely delivery of high-quality statistical outputs. Responsibilities: Develop, validate, and maintain SAS programs for the creation of SDTM and ADaM datasets, tables, listings, and figures (TLFs) according to statistical analysis plans (SAPs) and programming specifications. Ability to contribute to the development and implementation of Statistical Analyses Plan Perform quality control (QC) of programs and outputs generated by other statistical programmers to ensure accuracy, consistency, and adherence to company standards and regulatory guidelines. Collaborate with biostatisticians to clarify programming requirements, resolve data issues, and ensure the accurate implementation of statistical methodologies. Contribute to the development and review of programming specifications, mock TLFs, and other study-related documentation. Ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH-GCP) and internal Standard Operating Procedures (SOPs). Participate in team meetings and contribute to discussions regarding study design, data analysis, and reporting strategies. Proactively identify and implement process improvements to enhance efficiency and quality of programming deliverables. Maintain comprehensive documentation of programming activities and version control. May contribute to the development and maintenance of programming standards and macros. Qualifications: Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related scientific field. Minimum of3] years of experience in clinical statistical programming within the pharmaceutical, biotechnology, or CRO industry. Proficiency in SAS programming (Base SAS, SAS/STAT, SAS/GRAPH, SAS Macro Language). Strong understanding of CDISC standards, including SDTM and ADaM. Experience with regulatory submissions (e.g., NDA, BLA) is highly desirable. Solid understanding of clinical trial processes, ICH-GCP guidelines, and relevant regulatory requirements. Excellent attention to detail and strong problem-solving skills. Ability to work independently and as part of a collaborative team. Strong written and verbal communication skills. Experience with other programming languages (e.g., R, Python) is a plus. Knowledge of industry best practices for statistical programming. What We Offer: Opportunity to work on innovative clinical trials across diverse therapeutic areas. A collaborative and supportive work environment. Opportunities for professional growth and development. Competitive salary and benefits package. Show more Show less

The Senior Statistical Programmer will lead single and/or multiple clinical trials and be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR). The Senior Statistical Programmer will also review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and various Data Management (DM) documents (e.g., electronic Case Report Forms [eCRFs], edit checks, etc.), support DM with data cleaning activities, use global SAS macros and participate to internal initiatives to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs, and use Pinnacle 21 to validate SDTMs, ADaMs, and define.XMLs. The Senior Statistical Programmer will work collaboratively within Biostatistical study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Indero's standard operating procedures (SOPs) and processes. More specifically, the Senior Statistical Programmer must: Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time. Act as a Lead Statistical Programmer on multiple single studies. Review the statistical programming scope of work and budget at initiation of clinical trials and identify tasks that are out of scope. Review and provide input into various DM documents (e.g., eCRF, edit checks, etc.), SAPs, and TLF Shells. Support DM with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician. Develop/maintain/validate (as applicable) aCRFs according to protocol, eCRF, and Indero and/or Sponsor' standards and interpretation of Clinical Data Interchange Standards Consortium (CDISC) SDTM Implementation Guideline (IG) and Controlled Terminology (CT). Develop/maintain/validate (as applicable) specifications and Primary or QC statistical programming (as applicable) of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs based on protocol, aCRF, SAP, TLF Shells, Indero and/or Sponsor's standards and interpretation of CDISC SDTM IG, ADaM IG, and CT and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). Develop/maintain/validate (as applicable) of SDTM define.XML/.PDF, clinical SDTM Reviewer’ Guide (cSDRG), ADaMs define.XML/.PDF, and ADaM Reviewer’ Guide (ADRG) based on SDTM specifications, ADaM specifications, and Indero and/or Sponsor' standards and interpretation of CDISC Define guidelines and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21 and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs. Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and IAs. Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables. Participate to internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables, including but not limited to development/ improvement/validation of standard macros, templates, and programming standards and processes. Keep oneself abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements. May also: Mentor more junior Statistical Programmers. Requirements: Education Bachelor’ degree in Statistics, Computing Sciences or a related field; Master’s degree an asset Experience At least 7 years of clinical research experience in biotechnology, pharmaceutical or Contract Research Organization (CRO) industry, including 5 years of Statistical Programming and 2 years acting as a Lead Statistical Programmer. Knowledge And Skills Excellent exposure to clinical trial data, SAP, TLF Shells, and specifications. Excellent working knowledge of SAS; SAS certification an asset. Knowledge of XML programming an asset. Excellent working knowledge of CDISC standards and guideline; CDISC certification an asset. Excellent knowledge of drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP. Very organized and detail-oriented, with effective project planning and time management skills. Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands. Must be able to work independently and as part of a team. Strong verbal and written communication skills in English; Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Ongoing learning and development Work location Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required. About Indero Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India. Show more Show less

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based SAS Programmer to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Write SAS programs for use in creating analysis datasets, tables, listings, and figures Using SAS, program, validate and maintain mapped database Program edit checks for external data Coordinate communication and issues with Data Management regarding database specifications and data transfers Qualifications Bachelor / Master’s Degree in math, Statistics, health informatics, data science, computer science, or life sciences field SAS Ceritifcation SAS knowledge required and 1 to 2 years' experience is preferred Good English written/communication skills is required People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Senior SAS Programmers to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Propose and develop specifications for new projects and serve as a project team leader Write SAS programs for use in creating analysis datasets, tables, listings, and figures Using SAS, program, validate and maintain mapped database Program edit checks for external data Responsible for the setup, validation and maintenance of mapped databases, integration of external data with associated edit checks, writing programs independently with good quality for use in creating analysis datasets, tables, listings, and figures. Responsible for mapped database setup, validation and maintenance, and external data integration & edit checks, validation, and maintenance Qualifications Bachelor / Master’s Degree in math, Statistics, health informatics, data science, computer science, or life sciences field 5+ years' eperience with SAS Excellent knowledge of CDISC standards SAS Certification Thorough understanding of the pharmaceutical industry and Federal Regulations regarding electronic records Excellent analytical, written and oral communication skills Good English written/communication skills is required People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

In this role you will be part of our Centre of Excellence team working specifically in SDTM therefore extensive experience and knowledge is required in this area. Location: Home-based What you'll be doing: Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells. Performs quality control (source code review, double-programming and log review) of SAS programs. Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications. Prepares specifications for CDISC and other analysis data sets. Assists Data Management with SAS programming needs. Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team. Develops and validates general SAS macros. What we are searching for: BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work-related experience to be able to perform this role. 6-8 years of experience in SAS programming within the area of clinical trials. Prior experience using computerized information systems preferred. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques. Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms.

In this role you will be part of our Centre of Excellence team working specifically in SDTM therefore extensive experience and knowledge is required in this area. Location: Home-based What you'll be doing: Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells. Performs quality control (source code review, double-programming and log review) of SAS programs. Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications. Prepares specifications for CDISC and other analysis data sets. Assists Data Management with SAS programming needs. Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team. Develops and validates general SAS macros. What we are searching for: BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work-related experience to be able to perform this role. 6-8 years of experience in SAS programming within the area of clinical trials. Prior experience using computerized information systems preferred. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques. Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms.

In this role you will be part of our Centre of Excellence team working specifically in SDTM therefore extensive experience and knowledge is required in this area. Location: Home-based What you'll be doing: Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells. Performs quality control (source code review, double-programming and log review) of SAS programs. Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications. Prepares specifications for CDISC and other analysis data sets. Assists Data Management with SAS programming needs. Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team. Develops and validates general SAS macros. What we are searching for: BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work-related experience to be able to perform this role. 6-8 years of experience in SAS programming within the area of clinical trials. Prior experience using computerized information systems preferred. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques. Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms.

The Data Engineer will work closely with clients and the eCS Biometrics team to optimize the elluminate® platform for end-to-end solutions to aggregate, transform, access and report on clinical data throughout the life cycle of a clinical trial. This includes study design in elluminate®, collaboration on specifications, and configuration of the various modules to including Data Central, Clinical Data Analytics and Trial Operational Analytics, Risk-Based Quality Management (RBQM), Statistical Computing Environment (SCE) and Operational Insights. The Data Engineer will be involved in standard ETL activities as well as programming custom listings, visualizations and analytics tools using Mapper and Qlik. The position involves a high level of quality control as well as adherence to standard operation procedures and work instructions and a constant drive towards automation and process improvement. Key Tasks & Responsibilities Design, develop, test, and deploy highly efficient code for supporting SDTM, Custom reports and Visualizations using tools like MS SQL, elluminate® Mapper and Qlik Configure ETL processes to support of the aggregation and standardization of clinical data from various sources including EDC systems, SAS and central laboratory vendors Work with Analytics developers, other team members and clients to review the business requirements and translate them into database objects and visualizations Manage multiple timelines and deliverables (for single or multiple clients) and managing client communications as assigned Provide diagnostic support and fix defects as needed Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures Other duties as assigned CANDIDATE’S PROFILE Education & Experience 3+ years of professional experience preferred Bachelor's degree or equivalent experience preferred Experience with database/warehouse architecture, design and development preferred Knowledge of various data platforms and warehouses including SQL Server, DB2, Teradata, AWS, Azure, Snowflake, etc. Understanding of Cloud / Hybrid data architecture concepts is a plus Knowledge of clinical trial data is a plus - CDISC ODM, SDTM, or ADAM standards Experience in Pharmaceutical/Biotechnology/Life Science industry is a plus Professional Skills Critical thinking, problem solving and strong initiative Communication and task management skills while working with technical and non-technical teams (both internal to eCS and clients) Must be team oriented with strong collaboration, prioritization, and adaptability skills Excellent knowledge of English; verbal and written communication skills with ability to interact with users and clients providing solutions Excited to learn new tools and product modules and adapt to changing technology and requirements Experience in the Life Sciences industry, CRO / Clinical Trial regulated environment preferred Technical Skills Proficient in SQL, T-SQL, PL/SQL programing Experience in Microsoft Office Applications, specifically MS Project and MS Excel Familiarity with multiple Database Platforms: Oracle, SQL Server, Teradata, DB2 Oracle Familiarity with Data Reporting Tools: QlikSense, QlikView, Spotfire, Tableau, JReview, Business Objects, Cognos, MicroStrategy, IBM DataStage, Informatica, Spark or related Familiarity with other languages and concepts: .NET, C#, Python, R, Java, HTML, SSRS, AWS, Azure, Spark, REST APIs, Big Data, ETL, Data Pipelines, Data Modelling, Data Analytics, BI, Data Warehouse, Data Lake or related Show more Show less

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Essential Functions Provide statistical programming and validation for life sciences-related projects including clinical trial datasets and tables, listings, and figures. Access and convert data to SAS datasets and other file types from database management system and PC file formats (e.g., Microsoft Excel, text files). Work with external vendors to develop and/or monitor the content and structure of SAS datasets and other files. Work closely with statisticians and other statistical programmers to generate and validate outputs to ensure accuracy and ensure the quality and soundness of statistical programming algorithms. Provide input to specifications of tabulation and analysis datasets, validation plans, and other related documents Other duties as assigned. Necessary Skills And Abilities In-depth knowledge of statistical programming. Excellent communication and interpersonal skills, with the ability to work collaboratively in cross functional teams and with external partners. Ability to program in SAS and/or R preferred. Educational Requirements Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related discipline, or a combination of other education with 1+ years of relevant work experience. Experience Requirements Experience with CDISC data structures, such as SDTM and ADaM. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*** Show more Show less

Let’s build the future of medicine—together. Join Enveda as a Sr. Manager, Clinical SAS Programming in India and help us transform natural compounds into life-changing medicines. We’re a team driven by curiosity and innovation—are you ready to make a difference? Hybrid | India | Full-Time What Makes Us Enveda Life is smart, and we can learn from it. We’re reinventing drug discovery by harnessing nature’s intelligence. Our platform identifies new medicines four times faster than the industry standard—because patients can’t wait. What sets Enveda apart isn’t just what we do—it’s how we do it. Our culture is built on creativity, collaboration, and deep respect for each other. We believe “People Create All Value”, and our success is driven by the extraordinary team turning our mission into reality every day. We’re Proud Of The Momentum We’ve Built Jan 2024: Named a LinkedIn “Top Startup to Watch” Mar 2024: Forbes America’s Best Startup Employers Oct 2024: First drug to Phase 1 Clinical Trials Dec 2024: Raised a $130M Series C These milestones reflect the impact of our team and we’re just getting started, but they’re only possible because of the diverse talent, perspectives, and relentless drive of our team, and people like you. Your Role in Our Mission At Enveda, every role drives impact. As a Sr. Manager,Clinical SAS Programming, you’ll be at the forefront of delivering hope to patients everywhere. Your expertise in clinical programming will be critical in accelerating our mission to deliver submission-ready datasets and regulatory documentation—because every breakthrough starts with bold questions and brave actions. What You’ll Do Lead programming activities across studies and clinical development phases Oversee CRO deliverables for quality, timeliness, and regulatory compliance Provide technical oversight for SDTM, ADaM, Define.xml, DRGs, and TLFs We’re Looking For 8-12 years clinical programming exp. with leadership exposure Expert SAS skills (Base, Macro, SQL); strong SDTM, ADaM, Define.xml, TLF experience Bachelor's/Master's in Statistics, CS, Life Sciences, or related field Proven CRO management experience across selection, oversight, and delivery Strong Hands-on R skills for exploratory analysis and visualization Preferred: Familiarity with Pinnacle 21, CDISC validation, ISS/ISE, and automation tools If you’re passionate about innovation and impact, we encourage you to apply—even if you don’t meet every requirement. Our Values: Curiosity | Agency | Journey | Charity | Unity Benefits: Culture | Medical | Block Leaves | Work-Life Harmony At Enveda, we’re building a place where everyone can do the best work of their life. We are an equal opportunity employer and value diversity in all its forms. 👉Apply now and join a team committed to shaping the future of drug discovery. Show more Show less

TCS is hiring for Statistical Programmer!!! Job Location Mumbai/Pune/Bengaluru Experience Range 4 to 14 Years Educational Qualification(s) Required Any Life Science Graduate Interested can share their CV on babeeta.shahi@tcs.com Roles & Responsibilities:- Creation and validation of analysis data sets, tables, listings and figures . Creation and validation of ISS and ISE reports. . Development and testing of reusable Standard Programs . Development of SAS macros to work as utilities to automate routine activities . Remapping of old studies into ADaM structure . Build and maintain ADaM compliant Repository . Creation and validation of ADaM specification document . Assistance in creation of regulatory submission documents

Sr. Statistical Programmer - FSP (India) Join Cytel’s enthusiastic and collaborative Biometrics team by contributing to the overall success of our novel gene therapy development programs. The Sr. Statistical Programmer provides Statistical Programming technical support to team members. Key Responsibilities Effectively designs and codes SAS programs for assigned project(s), consistently meeting objectives of the project Codes complex SAS programs for applications designed to analyze and report clinical trial data and for electronic submissions of data in CDlSC format with minimal instruction or input from the supervisor Create specifications for derived/analysis datasets Program analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS Generate SDTM domains, ADaM datasets Performs quality control checks of advanced SAS code for datasets and output produced by other Statistical Programmers Performs review on define.xml and creates reviewers guide for SDTM and ADaM datasets Review, and maintain study documents per the standard process Perform other duties as assigned Technical And Communication Skills Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH Demonstrates intermediate knowledge of electronic submissions and CDlSC Proven technical proficiency in supporting daily operations and ensuring that project tasks are completed accurately and on schedule Effective communicator (written and verbal), especially within their area(s) of expertise Preferred Education And Experience MS in biostatistics or a related field, with 5-8 years of experience in the pharmaceutical industry, or BS in biostatistics or a related field, with 7-10 years of experience in the pharmaceutical industry Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law. Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies. Show more Show less

Key Accountabilities Project Management: Ability to fill Statistical Programming Lead role on projects Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget. Monitor project resourcing, project budgets, and identify changes in scope. Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Review statistical analysis plans and mock-shells. Review database set-up specifications. Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities. Interact with sponsors and internal stakeholders with regard to statistical programming issues. Assist project teams in the resolution of problems encountered in the conduct of their daily work. Statistical Programming For Assigned Projects Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings. Produce/QC dataset specifications and other process supporting documents and submission documentation. Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements. Training Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, and processes/procedures within other Parexel functional areas. Provide relevant training and mentorship to staff and project teams. Lead knowledge sharing forums and proactively support the development of the wider department. General Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in and/or lead process/quality improvement initiatives. Provide consultancy to internal and external sponsors with regard to statistical programming tasks. Represent Parexel at sponsor marketing and technical meetings. Assessment of technology and processes, to facilitate best practices and increase quality, efficiency, and productivity. Represent Statistical Programming on cross-functional technical initiatives. Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills Excellent analytical skills. Advanced knowledge of SAS programming techniques. Extensive knowledge and understanding of the programming and reporting process. Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Knowledge of the efficacy endpoints and analysis techniques specific to the disease being treated. Ability to learn new systems and function in an evolving technical environment. Strong project management skills. Strong organizational skills, ability to manage competing priorities, and flexibility to change. Attention to detail. Ability to successfully lead and mentor a global team. Work effectively in a quality-focused environment. Excellent time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Strong business/operational skills that include customer focus, commitment to quality management, and problem solving. Demonstrate commitment to refine quality processes. Good presentation skills. Ability to negotiate and influence in order to achieve results. Good business awareness/business development skills (including financial awareness). Client-focused approach to work. Good negotiation skills. Knowledge And Experience Competent in written and oral English. Excellent communication skills. Proven record of successfully leading teams in a statistical programming environment. Education Educated to degree level in a relevant discipline and/or equivalent work experience. Show more Show less

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 . Create SAS programs to generate derived analysis data sets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis d atasets and programming outputs Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis Support the electronic submission preparation and revi e w Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programmi ng assumptions and requirements ; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming spec ifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences ( GB D S) deliverables by consistently applying s tandards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work p ractices Identifies opportunities for increased efficiency and consistency within GB D S and our interactions with strategic vendors Independently leads and / or performs programming assignments with minimal supervision Support improvement initiatives Minimum Requirements: Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required . At least 5 years programming experience in industry recommended . For US positions: US military experience will be considered towards industry experience . Demonstrated proficiency in using SAS , R or other programming languages to produce deriv ed analysis datasets and TFLs. Have in -depth understanding of clinical data structure ( e.g. CD I SC standards) and relational database. Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21. Demonstrated ability in the handling and processing of upstream data, e.g., multiple d ata forms, workflow, eDC , SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM , Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Demonstrated ability to work in a team environm ent with clinical team members. Preferred Requirements : Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings ( e.g. NDA, BLA, MAA) Knowledge of the drug development process, clinical trial methodology , statistics and familiarity with global regulatory requirements Experience in other software packages ( e.g. R) Experience with the Linux operating system 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.