146 Adam Jobs

• Ensures that the Statistical Programming department meets timelines, provides high quality deliverables, complies with contractual project requirements and Standard Operating Procedures(SOPs), and conducts projects within budget. • May participate in the development of department SOPs and guidelines, promoting standardized and consistent processes to maximize the efficiency of the Statistical Programming department. • Responsible for staff development, training and retention. Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching. • Facilitates succession planning and maintains a Statistical Programming staff with diverse skills, abilities, and competencies meeting the business needs of the Statistical Programming department. • Makes recommendations for, and participates actively in hiring, onboarding, transferring, and terminating staff. • Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and statistical programming in order to effectively serve as a Statistical Programming department mentor. Develops and provides training for Statistical Programming associates. • Prioritizes activities across Statistical Programming projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals, creating solutions to address business and operational challenges. • Supports the assignment of, or directly assigns Statistical Programmers to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience. • May be responsible for leading or supporting projects across multiple studies or programs. • May support business development activities. • May participate in or lead departmental or corporate initiatives. • Performs other work-related duties as assigned. • Minimal travel may be required.

Role Overview: As a Senior Statistical Programmer at ProcDNA, you will leverage your advanced SAS and R programming skills along with proficiency in CDISC standards to support or lead one or more Clinical studies. You will be part of a passionate team that focuses on creating game-changing Commercial Analytics and Technology solutions for clients globally. Innovation is not just encouraged at ProcDNA, it is ingrained in our DNA. Key Responsibilities: - Having 6+ years of experience in SAS & R Programming - Hands-on experience with SDTM, ADAM, TLF including safety and efficacy analysis - Experience with CRF annotation, creation of datasets, and specs creation - Submission experience is a plus (define.xml, P21, ADRG, SDRG) - Able to lead 1 study under supervision - Demonstrates strong programming and domain expertise - Ability to execute a wide range of programming activities with minimal supervision - Identifying gaps in current programming best practices and offering suggestions - Ensuring adherence to standards and having an awareness of evolving industry standards - Developing an understanding of all applicable policies and procedures - Completing programming activities under supervision - Taking responsibility for timely completion of all assigned development tasks - Understanding and applying a basic knowledge of the industry Qualifications Required: - Experience working with RWD for use in pharmacoepidemiology research with practical knowledge in biostatistics applied to clinical/epidemiological research - Expertise in commonly used Real World Databases (Optum, Marketscan, Flatiron, JMDC, etc.) within the Real World landscape - Proficiency in R with expertise in other programming languages such as SQL or Python - Familiarity with AI/ML, data visualization, and reporting tools (Note: Additional details about the company are not provided in the job description),

Biostatistician I About The Role : We are seeking a skilled and detail-oriented Statistician to support statistical analyses for clinical research studies. This role involves designing and executing statistical components of protocols, generating randomization codes, and preparing annotated shell data displays. The Statistician will contribute to the development of statistical analysis plans and ensure the accuracy and compliance of data displays with regulatory standards. Statisticians report to the Biostatistics Manager and collaborate closely with cross-functional teams in a clinical research environment. Key Responsibilities: Conduct statistical analyses as outlined in statistical analysis plans , including generating statistical graphics and verifying randomization codes. Prepare statistical sections of clinical study protocols , including sample size calculations . Annotate shell data displays and provide specifications for the structure, content, and algorithms of status and analysis datasets. Perform and supervise quality control (QC) of data displays and inferential statistics. Design, plan, and execute biostatistical components of clinical studies using sound statistical methodology. Develop statistical analysis plans (SAPs) and reporting specifications. Review and validate tables, listings, and figures (TFLs) , tabulation datasets, and derived datasets. Analyze and interpret results from clinical studies independently or under guidance. Maintain project documentation and contribute to cross-functional interactions. Utilize advanced computer skills for documentation and reporting using MS Word, Excel, PowerPoint , and project management tools. Primary Skills: Statistical AnalysisSample size estimation, inferential statistics, protocol development ProgrammingProficiency in SAS and clinical data analysis software Data StandardsFamiliarity with CDISC , SDTM , and ADaM DocumentationAnnotated CRFs, SAPs, shell displays, and QC records CommunicationEffective verbal and written communication in English Secondary Skills: Clinical Research: Understanding of clinical trial methodology and regulatory requirements Quality Assurance: QC of datasets and statistical outputs Collaboration: Cross-functional teamwork and stakeholder engagement Project Organization: File management and audit readiness Mentorship: Support and guidance for junior team members Preferred Qualifications: Masters degree in Statistics or related field Minimum 3 years of experience as a Statistician for Senior level; minimum 1 year or EDETEK training and supervisory approval for non-Senior level Proficiency in SAS and similar clinical data analysis tools Experience in preparing statistical components of protocols and SAPs Strong analytical and organizational skill Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

As a Statistical Programmer II at Advanced Clinical, you will play a crucial role in providing programming support for clinical trials. Your responsibilities will include exceeding the expectations and responsibilities of a Statistical Programmer I, understanding and implementing CDISC and other regulatory standards, and following internal SAS programming conventions. You may also serve as a programming lead, prepare programming specifications for SDTM, ADaM, and other derived datasets, and work with cross-functional team members to ensure accurate and high-quality statistical outputs. In this role, you will apply your knowledge of SAS programming to program and develop statistical outputs according to the statistical analysis plan and other specifications. This includes working on SDTM, ADaM, or other derived datasets, tables, listings, figures, and reviewing case report form design. Additionally, you will need to follow Standard Operating Procedures (SOPs) and have a strong understanding of departmental and company procedures to guide others effectively. The ideal candidate for this position should have a degree in Statistics, Computer Science, or a closely related field. However, work experience may be substituted for the degree. You should have a minimum of 2 years of direct SAS programming experience in pharmaceutical development or CRO environment, along with good knowledge of medical terminology and the conduct and analysis of clinical trials. Knowledge of relevant industry data standards such as CDISC SDTM, ADaM, etc., is also required. Excellent oral and written communication skills, organizational skills, and attention to detail are essential for this role. At Advanced Clinical, we are committed to diversity and inclusion throughout our organization. We believe that a diverse staff enables us to draw on different perspectives, enhance our efficiency and effectiveness, and strengthen our legitimacy and relevance in delivering services to our clients. We value individuals from various backgrounds and cultures and prioritize an inclusive workplace that welcomes diverse ideas and appreciates valuable experiences. Advanced Clinical is an equal opportunity employer, and our commitment to diversity and inclusion applies to all aspects of employment. We provide accommodations for individuals with disabilities or handicaps to ensure a supportive and inclusive work environment. If you require any accommodations, please inform your Recruiter to discuss available alternatives.,

Phastar is a globally recognized biometric Contract Research Organization (CRO) that partners with pharmaceutical, biotechnology, and medical device companies to deliver high-quality biostatistics, programming, data management, and data science services. Accredited for excellence by Best Companies, Phastar is dedicated to fostering a rewarding work environment and is committed to ensuring employee engagement, workplace satisfaction, and a healthy work-life balance. With a presence in multiple countries worldwide, Phastar stands as a leader in specialized biometrics, emphasizing quality and technical expertise as its key values. As a clinical programmer with a strong background in SAS and R programming, you will play a crucial role in bridging legacy clinical trial systems with modern open-source solutions while adhering to CDISC standards and regulatory requirements. Your responsibilities will include converting existing SAS programs for SDTM and ADaM datasets, developing interactive applications using R Shiny, and creating parameterized R Markdown reports and Shiny dashboards for enhanced clinical data visualization. Moreover, you will design and implement CDISC-compliant data pipelines, conduct SAS-R validations, and support regulatory submissions, among other duties. The ideal candidate will possess over 8 years of SAS experience, proficiency in R programming and R Shiny, and a demonstrated ability to convert SAS programs to R. Additionally, a deep understanding of SDTM/ADaM implementations, clinical data checks, and clinical trial protocols is required. Knowledge of Python coding is considered a plus. Phastar offers a supportive and flexible work environment, structured training and development plans, and competitive salary and benefits. If you are passionate about quality, technical expertise, and contributing to cutting-edge data science techniques, this is an excellent opportunity to join a renowned CRO. This position is open for remote work and applications are welcome from candidates located in the UK and selected European countries. If you believe you have the necessary skills and motivation for this role, we encourage you to apply and be a part of our award-winning team at Phastar.,

Hiring for Statistical Programmers with strong experience in end-to-end programming ( SDTM, ADaM, TLF ) for a leading Clinical Research organistaion. Location: Remote Role & responsibilities Title: Senior Statistical Programmer Experience: 6+ years Skills Required: Technical: R (expert), Python (proficient), SQL (proficient), experience in IHD software Experience in RWD , mainly in Pharmacology and Epidemiology (post-marketing) Hands-on experience with Real World Databases Optum, Marketscan, Flatiron, JMDC Familiarity with AI/ML, Data Visualization, and reporting tools to apply share Resumes with Puja.k@maxisclinical.com Regards Puja Khemchandani

You will be responsible for creating and maintaining CDISC compliant datasets (SDTM, ADaM) and generating Tables, Listings, and Figures (TLFs) for clinical study reports. Your role will involve performing efficacy analyses using R programming, developing standard macros for data manipulation, and participating in study handling activities if you are at a senior level. You will utilize the CRT package for data analysis and contribute to Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) analyses. Working within a Functional Service Provider (FSP) environment, you will troubleshoot programming issues, ensure compliance with regulatory guidelines and company SOPs, and collaborate with biostatisticians and clinical data managers to support clinical trial activities. Additionally, you will be responsible for developing and maintaining programming documentation. Requirements: - 6 to 14 years of relevant experience in statistical programming. - Strong knowledge of CDISC standards (SDTM, ADaM). - Extensive experience in generating TLFs. - Proficiency in R programming (minimum 6 months experience). - Experience in efficacy analysis. - Experience with CRT package preferred. - Experience with ISS and ISE preferred. - Experience working in an FSP environment. - Knowledge of utilizing and debugging standard macros. - Study handling experience preferred for senior levels. Qualifications: - Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, or a related field. - Proven experience in statistical programming for clinical trials. - Strong understanding of clinical data management principles. - Excellent problem-solving and analytical skills. - Ability to work independently and as part of a remote team.,

Position: Data Engineer, Sr - I *** JOB DESCRIPTION *** OVERVIEW The Data Engineer, Sr - I will work closely with clients and provide high level technical consulting services, configuration of the elluminate platform, development and oversight for specific projects that include trial configuration, quality control, project management, assessing new technologies, process improvements, system validation, SOP development, custom analytics development, clinical software implementations and integrations, platform configuration, ETL and custom analytics development. As a Data Engineer, Sr - I, you will serve as the primary technical lead, spearheading consulting efforts related to clinical systems software. You will also design and develop reporting programs as needed. KEY TASKS & RESPONSIBILITIES Leading consulting efforts and providing high-level technical consulting services to clients, including configuring the elluminate platform and overseeing specific projects such as trial configuration, quality control, and project management. Designing, developing, testing, and deploying efficient SQL code to support SDTM, custom reports, and visualizations using tools like MS SQL, elluminate Mapper, and Qlik. Providing technical guidance, training, and support to team members and users on processes, technology, and products. Managing multiple timelines and deliverables for single or multiple clients, and handling client communications as assigned. Possessing high-level debugging skills for ETL or analytical issues by referring to the required source data. Demonstrating in-depth knowledge of at least one Elluminate module, with hands-on experience in all other modules. Delivering proactive technical support for all client-reported support tickets. Facilitating client onboarding workshops and conducting training sessions for end users on the Elluminate platform. Configuring, migrating, and supporting the elluminate platform for assigned clients. Creating and maintaining all required specifications and quality control documents as per SOP and processes. Ensuring compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures. Position: Data Engineer, Sr - I CANDIDATES PROFILE Education/Language: 5+ years of professional experience in a Services or Consulting role preferred Bachelor's or Master's degree in science, technical or business discipline or equivalent experience preferred 5+ years in database design and development experience preferred Understanding of Cloud / Hybrid data architecture concepts is a plus Prior experience in customer facing roles 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 Experience in Data Capturing tools (Rave, Veeva, InForm, IVRS) Professional Skills & Experience: Have critical observation and communication skills to Identify any gaps in processes or product Ability to work with various 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 Experience in the Life Sciences industry, CRO / Clinical Trial regulated environment preferred Experience in regulatory computer systems validation a strong plus Demonstrating strong analytical and problem-solving skills to identify issues and develop creative solutions that drive results. Conveying information clearly and concisely to diverse audiences, facilitating understanding and collaboration. Working effectively in a team environment, contributing to group objectives, and supporting colleagues. Adapting to changing circumstances and accepting new challenges with a positive attitude. Understanding clinical trial data and applying CDISC, SDTM/AdAM standards. Performing other duties as assigned. Position: Data Engineer, Sr - I Technical Skills & Experience: Proficient in SQL, T-SQL, PL/SQL programming or R Package or Python or SAS Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel Experience with multiple Database Platforms: Oracle, SQL Server, Teradata, DB2 Oracle Experience 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

Join Clarios industry-leading Digital Physiology team as a Principal Statistical Programmer, where your expertise will drive innovation in clinical research. This is a unique opportunity to lead advanced statistical programming for cardiac safety trials, shaping the future of digital health through cutting-edge data science and global collaboration. What you'll be doing Statistical Programming & Data Standards Lead and coordinate all statistical programming activities for cardiac safety trials. Develop, test, and maintain SAS code to generate CDISC-compliant datasets (SDTM, ADaM). Produce and maintain submission-ready datasets and electronic submission packages (e.g., define.xml, reviewer’s guide) in accordance with FDA guidelines. Team Leadership & Mentorship Manage direct reports in a line or matrix capacity, including work allocation, resource planning, and professional development. Conduct onboarding and training on statistical programming practices and SOPs. Mentor junior staff and provide guidance on programming methodologies and quality standards. Process Improvement & Strategic Initiatives Identify and implement process improvements to enhance operational efficiency. Develop and maintain SOPs, SWIs, templates, and playbooks for programming deliverables. Drive initiatives for future analyses, data quality, and standardization. Cross-functional Collaboration & Project Management Collaborate with cross-functional teams to define scope and timelines for statistical deliverables. Manage client commitments and ensure timely delivery of assigned projects. Maintain accurate tracking of deliverable statuses and dates. What we're looking for Ph.D. with 5+ years of relevant industry experience, M.S. with 7+ years of relevant industry experience or B.S. with 10+ years of relevant industry experience A degree in medical, health, public, or general science—or an equivalent combination of education and experience sufficient to perform job duties Strong experience in clinical trials , preferably within a CRO or pharmaceutical research organization Proficiency in SAS programming , including creation, testing, and maintenance of CDISC-compliant datasets (SDTM, ADaM) Experience with electronic submission packages and regulatory interactions (e.g., FDA) Familiarity with clinical protocols and Statistical Analysis Plans Experience with TFL generation is a plus Solid understanding of the pharmaceutical drug development process At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials.

Experience in leading a team of statistical programmers for a compound/indication or therapeutic area Proficiency in SAS / R programming languages to Program and validate ADaM , TFL and statistical analyses In-depth understanding of SAS programming concepts and techniques in drug development process and clinical study life cycle Good to have experience in other statistical programming languages (R). In-depth understanding of CDISC standards and therapeutic area (Oncology, Immunology , Neuroscience etc.) Experience with regulatory filings. Ability to effectively represent the Statistical Programming Organization in cross functional teams (Statisticians, Clinical Data Management, Medical Writing, Regulatory Publishing and Clinical Operations). Contact Person - Sangeetha Tamil Email - sangeetha@gojobs.biz

Role & responsibilities Create and Validate Safety and Efficacy Analysis Datasets in adherence with CDISC and client specific standards and maintain quality and accuracy. Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy. Create Study specific or general macros and finalize programming specifications/mock-ups. Adhere to programming specifications and study specific requirements, including completion and filing of required documentation. Plan and organize workload to ensure effective time management and adherence to project specific timelines. Preferred candidate profile 5+ years work experience in ADAM and R programming Experience with R Packages, R programming - Data Manipulation R Shiny dashboard is a plus R Markdown is a plus R Validation and Debugging options experience

Creation and validation of analysis data sets, tables, listings and figures Creation and validation of ISS and ISE reports. Developing and testing of reusable Standard Programs Developing SAS macros Creating ADaM structure and compliant Repository Required Candidate profile Life science graduate / Computer science graduate/ Statistical graduate Minimum 2+ years of experience in SAS programming International BPO experience is mandatory Proficient in SAP, CRF, CTR reviews

Job Title: Biostatistical Programmer (SDTM & ADaM) Experience: 5+ years Employment Type: Full-time Location: Hyderabad/Bangalore/Delhi/remote Industry: Pharmaceuticals / Clinical Research / CRO Functional Area: Biostatistics / Programming / Clinical Data Management About the Role We are seeking a skilled Biostatistical Programmer with 57 years of experience and strong expertise in CDISC standards (SDTM & ADaM) . This role involves developing, validating, and maintaining datasets and statistical outputs to support clinical trial submissions. You will work closely with biostatisticians, data managers, and clinical teams to ensure high-quality deliverables aligned with global regulatory requirements. Key Responsibilities Develop, validate, and maintain SDTM and ADaM datasets in compliance with CDISC standards and regulatory guidelines (FDA, PMDA, EMA). Program and validate tables, listings, and figures (TLFs) for clinical study reports and regulatory submissions. Ensure programming deliverables meet quality, timeline, and compliance standards. Collaborate with statisticians and clinical teams to translate analysis specifications into efficient programming solutions. Perform data quality checks and resolve issues in coordination with data management. Contribute to standardization efforts including macros, libraries, SOPs, and best practices. Support ad-hoc requests , exploratory analyses, and regulatory audits. Required Skills & Qualifications Bachelor’s/Master’s degree in Biostatistics, Computer Science, Life Sciences , or related field. Strong programming skills in SAS (Base SAS, SAS/STAT, SAS/Macro) , Python , and R . Hands-on experience with SDTM and ADaM dataset creation and validation . Solid understanding of CDISC standards and regulatory submission requirements. Knowledge of clinical trial processes , ICH-GCP guidelines , and statistical concepts. Strong problem-solving , attention to detail, and documentation skills. Experience with Cloud environments like AWS and Azure . Good to Have (Optional) Experience with Define.xml , Pinnacle 21 , and e-submission tools . Exposure to Life Sciences , Pharma/Clinical Research , or CRO settings . Familiarity with safety and efficacy analysis in clinical trials. How to Apply Interested candidates can apply directly through Naukri or send their updated resume to shyamala.gunde@excelra.com

About The Role Skill required: Life Sciences (AR&D) Services - SDTM Programming Designation: Associate Qualifications: Any Graduation,BE,BTech Years of Experience: 1-3 yrs 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

- Experience Required: 5+ years into clinical SAS Programming Requirements: - Strong experience in Base SAS, Advance SAS - Must have good experience in ADaMs, table, listing and figure creation. - Good to have study lead exposure.

Minimum experience: 8 years. We're seeking someone who brings: Extensive hands-on experience in End to End programming A strategic mindset and the ability to lead complex projects Strong collaboration skills with cross-functional clinical teams A passion for science-driven programming that impacts patient outcomes If you're ready to take on a high-impact role with a global sponsor we’d love to connect!

The Senior Biostatistician plays a pivotal role in the research and development of clinical projects by applying statistical methods and providing insights through data analysis. This position requires expertise in R programming and a deep understanding of statistical techniques such as Analysis of Variance (ANOVA) and Analysis of Covariance (ANCOVA). The Senior Biostatistician will not only collaborate with various teams to ensure compliance with regulatory standards but also contribute to the development of statistical analysis plans and the interpretation of results. Given the importance of accurate statistical evaluations in clinical trials, this role is critical to the decision-making processes that impact patient outcomes and the overall success of pharmaceutical developments. You will lead projects and mentor junior biostatisticians, making your contribution vital to enhancing the organization's capabilities and ensuring the integrity of research findings. Develop and implement statistical analysis plans for clinical studies. Perform statistical analyses using R, focusing on ADaM, ANOVA, and ANCOVA methodologies. Collaborate with clinical research teams to define analysis objectives and timelines. Create and validate datasets to ensure accuracy and compliance with regulatory standards. Generate and interpret statistical results to contribute to clinical study reports. Work closely with data managers to design data collection tools and processes. Conduct exploratory data analyses and prepare visualizations to communicate findings effectively. Participate in protocol development and provide statistical input on study design. Mentor and supervise junior statisticians and biostatisticians. Conduct peer reviews of statistical analyses and reports executed by peers. Stay current with biostatistics trends, methodologies, and regulatory guidance. Present statistical findings to stakeholders and at scientific meetings. Assist in regulatory submissions by preparing statistical sections of FDA submissions and other documents. Participate in interdisciplinary project meetings and collaborate with cross-functional teams. Continuously improve statistical practices and methodologies within the team. Required Qualifications Master's or PhD in Biostatistics, Statistics, or related field. Minimum of 5 years of experience in a biostatistical role within the pharmaceutical or biotechnology industry. Proficiency in R programming for statistical computing and data visualization. Experience with ADaM data standards and regulatory guidelines. Strong knowledge of ANOVA, ANCOVA, and other statistical methodologies. Excellent understanding of clinical trial design and regulatory requirements. Proficiency in other statistical software such as SAS is highly desirable. Exceptional analytical and problem-solving skills. Ability to communicate complex statistical concepts to non-statistical audiences. Experience in leading statistical analyses for multiple clinical projects simultaneously. Strong attention to detail and commitment to data integrity. Demonstrated ability to work collaboratively within a team environment. Experience mentoring or training junior staff members. Published research or contributions to scientific literature is a plus. Excellent organizational and time management skills. Strong interpersonal skills and ability to work in a diverse environment.,

As an Implementation Consultant, you will be responsible for managing and assuming accountability for all aspects of projects related to implementation. Your key responsibilities will include guiding the client through release planning, managing communication throughout the team and stakeholders, leading product implementation efforts, coordinating with customers, product SME, and other teams, managing the quality of implementation deliverables, and documenting and reporting status on Risks, Issues, Actions, and Decisions. You will need to identify, report, and manage risks while overcoming project obstacles. Acting as a client liaison and representative, you will communicate client feedback to appropriate representatives and act to resolve outstanding issues on behalf of the client in a timely manner. Understanding the client's clinical landscape, you will provide techno-functional solutions to evolving client needs. Your role will involve analyzing and understanding current business processes, events, and flows in Clinical Trial Development. You will create SOPs and Work instructions for the implementation/delivery team to ensure a smooth transition of services from implementation to support. Additionally, you should be able to incorporate feedback and input from customers, partners, and in-house teams on product features. Desired Skills: - Experience in the Lifesciences and Pharmaceutical industry is essential - Good experience in SQL, APIs, and Integrations - Good understanding of CDASH, SDTM, and ADAM standards - Good understanding of EDC Systems, CTMS Systems, IRT Systems, and LAB Systems - Knowledge of clinical trial domain, EDC study setup, and clinical reporting - Ability to build clinical reports and dashboards - Relevant degrees such as Bachelor's and Master's Degree in Healthcare, Computer Science, Technical, Engineering, Computer, Computer Engineering, Computer Programming - 3-5 years of experience as a Product Manager or 1-2 years of experience as a Product Owner - Comfortable and familiar with the Agile Working Environment - Experience working with all phases of SDLC - Familiarity with FDA regulations such as 21 CFR Part 11 and GxP is a bonus - Experience working in the complete product life cycle of two or more products - Technical knowledge including Software Development and Web Development - Experience with the use and configuration of healthcare software applications (preferably clinical),

The Statistical Programmer at Level 2 reports to the Principal Statistical Programmer 3/ Lead, Statistical Programming (L4 (3) or M1), and is responsible for independently working on most of the Mapping activities (SDTM/Client specific mappings) of simple and medium complexity for the assigned clients in the given environment for standard domains. As a Statistical Programmer, your role includes understanding the clinical domain, mapping logic, and data issues, as well as learning the product/system/mechanism used for SDTM mapping. You should possess knowledge and skills in clinical domain, familiarity with CDISC Standards (SDTM Knowledge, ADaM, Submission package), SAS Programming (Experience up to 2 years), with Python Programming and R Programming being considered as added advantages. Additionally, good communication skills, a learning attitude, and being a good team player are essential for this role. The ideal candidate should have a Graduation in Pharmacy/Computer Science or any equivalent graduation from a reputed institute with a total experience between 2 - 4 years. Responsibilities of the role include the ability to pick up multiple tools/technologies on the job, import and export raw data, contribute to Mapping specifications, utilize SAS/R programming/Python programming skills for clinical trial study submissions, develop programs identifying data issues, and building CDISC/regulatory compliant datasets. Furthermore, you are expected to understand CRF annotations, check for consistency with raw data, debug custom functions/SAS Macros, fix issues, have a good understanding of clinical data and domain, follow Client Processes and SOPs, assist senior team members in quality control processes, assist with team metrics, communicate with internal teams to create deliverables for pharmaceutical and CRO clients, work in collaboration with Biostatistics and Data Management members on clinical projects, communicate with programming and statistics leads, and ensure compliance with company policies/SOPs. About Us: Saama automates key clinical development and commercialization processes with artificial intelligence (AI), Generative AI, and advanced-analytics, accelerating your time to market. Saama offers AI-backed SaaS solutions as well as product-based industry services and accelerators. Discover more at saama.com.,

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS. ZS Life Science R&D Technologist in Clinical development ZS life science R&D team partners with client to discover and develop innovative medicines that improve patient's lives. Our work spans across consulting, analytics and technology (services and platforms) projects across the several domains. We have 3500+ zs professional that are delivering R&D programs, $100MM+ invested in R&D data, analytics and technology assets and 100+ clients on R&D programs. Our Clinical/Drug Development division displays a substantial history of contributing to numerous client projects with significant results in the drug development. The Drug Development R&D Technologists possess a deep understanding of technological solutions for clinical development processes including clinical study design, data management, analytics, and quality risk management platforms and products. They are well-versed in software related to clinical trial protocol design, electronic data capture (EDC), external data capture, data conformance, transformation, analysis, and reporting. Our team is well versed about industry standards such as CDISC, FHIR, OMOP, and their respective usage. Our team specializes in designing bespoke solutions or products implementation for clinical design, data management, and analytics systems. Our team has deep understanding of EDC tools like Rave, Veeva, InForm, openClinica, clinical data repositories like SAS LSAF, Oracle LSH, eCS elluminate, Metadata Repositories like Nurocor, Sycamore, Formedix, statistical computing environments like Sycamore, Domino, Sas Viya systems, Clinical data review systems, RBQM systems, and more. With experience as solution architects, business analysts, or techno-functional SMEs in GXP compliant validated environments, they guide the creation of solution, data flows and strategies for building clinical development and data management systems. Their offerings encompass technical advisory, consultancy, developing of clinical data platforms and products, system integration, and intelligent automation. Additionally, the team has created innovative tools through advanced technology and data science, aiding numerous clients in expediting the drug development process. What You'll Do You will spearhead the design & implementation of various innovative solutions in the realms of clinical trial, data management, analytics and RBQM. As a solution leader, your role will involve strategizing, offering tech consultancy, conducting assessments, and overseeing technology projects as the solution leader. You will be engaging with clients to review clinical business processes, determining requirements, establishing user narratives, and delivering solutions that have significant impact. You will lead requirements gathering activities and collaborate with product owner to prioritize and groom the backlog to ensure appropriate level of detail is captured at the right time You will lead team who review and Author high-level user stories and develop related tasks, acceptance criteria and review test cases Your team will work closely with project teams in creating requirement Specifications, requirement traceability metrics , user guides and other project requirement documents You will plan and facilitate various requirement gathering, solution meetings and artefacts You will work on creating process flows based on client and internal project discussions You will work to perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming Your team will act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules You will work in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community. What You'll Bring Bachelor's degree in engineering / Pharma/ Bioinformatics / Medicine or related disciplines Master's degree in business analyst, Engineering or Science preferred. 8+ years of experience working within Life Science Domain as solution architect / business analyst / data analyst is required. Experience of working in any of Clinical trial design, data management, analytics and RBQM system development, product implementation and Integration like EDC (Rave, Veeva, InForm), Non-EDC(ePRO, LAB,eCOA) , clinical data repository (CDR - SAS LSAF, Oracle LSH, eClinical elluminate ), Metadata Repository (MDR - Nurocor, Sycamore, Formedix) , statistical computing environment (Domino, Sas Viya) system, CTMS, eTMF, CDMS is required. Strong verbal and written communication skills with ability to articulate results and issues to internal and client teams Experience in driving requirements discussions, workshops and coordinating with internal and external stakeholders, across time zones, during the planning and delivery of technology projects is required Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. Exposure to clinical data standards like CDISC (SDTM, ADaM), FHIR, HL7, USDM is required. Experience in building and delivering GxP compliant solutions for large enterprise program is required. Exposure to programming language like R, Python and SAS is preferred. Additional Skills Strong client presence and ability to communicate verbally and in writing complex domain concepts to all audiences. Significant supervisory, coaching and hands-on project management skills. Ability to manage a virtual global team environment that contributes to the overall timely delivery of multiple projects. Willingness to travel to other global offices as needed to work with client or other internal project teams. In-silico, digital twin, and/or modeling experience. Perks & Benefits: ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth and professional development. Our robust skills development programs, multiple career progression options and internal mobility paths and collaborative culture empowers you to thrive as an individual and global team member. We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections. Travel: Travel is a requirement at ZS for client facing ZSers business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures. Considering applying At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems-the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive. If you're eager to grow, contribute, and bring your unique self to our work, we encourage you to apply. ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law. To complete your application: Candidates must possess or be able to obtain work authorization for their intended country of employment.An on-line application, including a full set of transcripts (official or unofficial), is required to be considered. NO AGENCY CALLS, PLEASE. Find Out More At:

The R&D Programmer III position at Teva Pharmaceuticals in Bangalore, India offers an exciting opportunity for a Senior Clinical Programmer to support clinical projects and regulatory submissions. As part of a global team dedicated to making good health more affordable and accessible, you will play a lead role in generating and validating analysis datasets, tables, listings, and figures. Your expertise in SAS programming will be crucial in developing global data standards, including SDTM, ADaM, and Teva's database structure. Your responsibilities will include working at the project level, providing input for budget planning, delivering assignments with quality and within timelines, overseeing contingent workers and/or vendors, and leading/co-leading clinical programming for studies or regulatory submissions. You will also be involved in developing, reviewing, documenting, and validating generic SAS macros, as well as initiating and leading new processes and methodologies to improve operational efficiency. To qualify for this role, you should have a Bachelor's Degree, Master's Degree, or PhD in Science, Statistics, Information Technology, or a related field, along with relevant work experience. Specifically, a Bachelor's Degree plus 3 years or a Master's Degree plus 2 years of experience is preferred. Additionally, experience in SDTM and ADaM, familiarity with CDISC Guidelines, and a commitment to Teva's Equal Employment Opportunity principles are essential. If you are passionate about making a difference in the pharmaceutical industry and eager to contribute your clinical programming expertise to a leading global manufacturer of generic medicines, we encourage you to apply for the R&D Programmer III position at Teva Pharmaceuticals today.,

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. As a Manager in Clinical Data & Technology within Life Sciences Consulting at EY, you will be part of our Life Sciences sector team, assisting clients in reimagining their clinical data strategies and implementing cutting-edge solutions across trial data capture, management, and analytics. You will play a strategic role in shaping next-generation clinical data landscapes. Your responsibilities will include driving consulting engagements around clinical data transformation, SDTM mapping, CDASH adoption, and standards harmonization. Additionally, you will lead client workshops, diagnostic assessments, and solution design initiatives focused on clinical data platforms. You will be responsible for translating regulatory and business needs into technology-enabled clinical data strategies and guiding clients on best practices in data governance, metadata management, and submission readiness. It is essential to stay current on emerging trends in digital trials, RWD/RWE, and AI in clinical data. To excel in this role, you must possess in-depth knowledge of clinical data management, CDISC standards (SDTM, ADaM, CDASH), and experience in implementing or advising on clinical systems (EDC, CTMS, eTMF, etc.). Consulting experience with client-facing roles in data/process transformation projects, as well as project and team leadership experience in global delivery contexts, are crucial skills. Additionally, having experience with clinical data warehouses, SAS programming, RAVE, or Medidata, familiarity with EMA/FDA guidance related to electronic records and submissions, and an understanding of data science or AI/ML in the context of clinical trial optimization are considered nice-to-have skills. Join EY in building a better working world, where diverse teams in over 150 countries provide trust through assurance and help clients grow, transform, and operate. Working across assurance, consulting, law, strategy, tax, and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.,

Biostatistician I Job Description: We are seeking a skilled and detail-oriented Statistician to support statistical analyses for clinical research studies. This role involves designing and executing statistical components of protocols, generating randomization codes, and preparing annotated shell data displays. The Statistician will contribute to the development of statistical analysis plans and ensure the accuracy and compliance of data displays with regulatory standards. Statisticians report to the Biostatistics Manager and collaborate closely with cross-functional teams in a clinical research environment. Key Responsibilities: Conduct statistical analyses as outlined in statistical analysis plans , including generating statistical graphics and verifying randomization codes. Prepare statistical sections of clinical study protocols , including sample size calculations . Annotate shell data displays and provide specifications for the structure, content, and algorithms of status and analysis datasets. Perform and supervise quality control (QC) of data displays and inferential statistics. Design, plan, and execute biostatistical components of clinical studies using sound statistical methodology. Develop statistical analysis plans (SAPs) and reporting specifications. Review and validate tables, listings, and figures (TFLs) , tabulation datasets, and derived datasets. Analyze and interpret results from clinical studies independently or under guidance. Maintain project documentation and contribute to cross-functional interactions. Utilize advanced computer skills for documentation and reporting using MS Word, Excel, PowerPoint , and project management tools. Primary Skills: Statistical Analysis: Sample size estimation, inferential statistics, protocol development Programming: Proficiency in SAS and clinical data analysis software Data Standards: Familiarity with CDISC , SDTM , and ADaM Documentation: Annotated CRFs, SAPs, shell displays, and QC records Communication: Effective verbal and written communication in English Secondary Skills: Clinical Research: Understanding of clinical trial methodology and regulatory requirements Quality Assurance: QC of datasets and statistical outputs Collaboration: Cross-functional teamwork and stakeholder engagement Project Organization: File management and audit readiness Mentorship: Support and guidance for junior team members Preferred Qualifications: Master's degree in Statistics or related field Minimum 3 years of experience as a Statistician for Senior level minimum 1 year or EDETEK training and supervisory approval for non-Senior level Proficiency in SAS and similar clinical data analysis tools Experience in preparing statistical components of protocols and SAPs Strong analytical and organizational skill Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

Job Description Job Description: We are seeking a detail-oriented and experienced Biostatistician II to support statistical analyses for clinical research studies. This role involves developing and validating SAS programs, preparing statistical documentation, and ensuring compliance with regulatory standards such as CDISC. The ideal candidate will have a strong foundation in statistics, clinical trial methodology, and statistical programming. Key Responsibilities: Develop, validate, and maintain SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) as per statistical analysis plans. Design and verify randomization codes to ensure clinical trial integrity. Prepare statistical sections of protocols, including sample size calculations and annotated shell data displays. Provide specifications for the structure, content, and algorithms of status and analysis datasets. Perform and oversee quality control (QC) of data displays and datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM). Conduct independent validation of datasets created by other programmers or statisticians. Maintain project documentation including protocols, annotated CRFs, SAPs, and programming/QC records. Organize and manage electronic project directories to ensure accessibility and version control. Mentor junior programmers and provide training on SAS programming and clinical data standards. Primary Skills: Statistical Programming: Proficiency in SAS for clinical data analysis Clinical Research: Understanding of clinical trial design , randomization, and statistical methodology Data Standards: Familiarity with CDISC , SDTM , and ADaM Quality Assurance: Experience in QC processes and dataset validation Documentation: Ability to create and maintain technical and regulatory documentation Secondary Skills: Statistical Analysis: Sample size estimation, inferential statistics, protocol development Data Management: Annotated CRFs, dataset specifications, metadata handling Communication: Clear documentation and collaboration with cross-functional teams Mentorship: Training and guiding junior staff in programming and standards Project Organization: File management, version control, and audit readiness Preferred Qualifications: Master's degree in Statistics or related field (or Bachelor's with equivalent experience) Minimum 3 years of experience as a Biostatistician in the clinical research industry Proficiency in SAS and clinical data analysis software Experience with CDISC standards and regulatory compliance Prior experience in mentoring or training junior team members Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

ROLES and RESPONSIBILITIES: Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency Support the development and implementation of a programming ecosystem to enable successful project deliverables Review statistical analysis plans, mock-shells, database set-up specifications Validate or Review the Programming packages (includes the aCRFs, specifications and datasets, Define.XML and Reviewers Guides (for both SDTM and ADaM) Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables Develop innovative solutions to standardize, automate and optimized efficiency and quality Proactively addresses project uncertainties to minimize risk and alerts or escalates the issue to the appropriate person (project team member, lead biostatistician, or management), identifies, communicates, and overcomes technical and interpersonal obstacles Development and maintenance of tracking systems, folder systems and archival of analysis Contributes strategies that allow multi-tasking or efficient implementation to reduce execution time to meet deadlines in fast-paced environment Build a team of programmers to support ongoing pipeline expansion