275 Sdtm Jobs - Page 2

Job Title: Senior Clinical Data Scientist / Clinical Data Analyst Experience: 7+ Years Location: Bangalore / Chennai / Hyderabad / Noida / Gurgaon (India) Industry: Pharmaceutical / Healthcare / Life Sciences Employment Type: Full-time Job Summary: We are seeking a highly experienced and analytical Senior Clinical Data Scientist / Analyst with 7+ years of experience in clinical data analysis, pharmaceutical research, and data science methodologies . The ideal candidate will have hands-on experience working with EMR/EHR data , advanced SQL , and machine learning models to derive actionable insights that support clinical research and drug development. Key Responsibilities: Analyze and interpret complex clinical and EMR data to support real-world evidence (RWE), HEOR, and clinical trial analysis. Design and develop statistical and machine learning models to predict patient outcomes, drug efficacy, and safety. Perform deep-dive analytics using Advanced SQL (CTE, RANK, PARTITION) for cohort identification and data transformation. Collaborate with cross-functional teams including biostatisticians, clinical operations, and regulatory affairs. Ensure data quality and integrity from diverse sources like EMR, claims, lab systems, and clinical trial management systems (CTMS). Automate data pipelines and implement best practices in reproducible analytics. Create dashboards, data visualizations, and reports for stakeholders and medical affairs teams. Stay up to date with current industry trends in real-world data (RWD), clinical informatics, and regulatory requirements. Required Skills: 7+ years of experience in clinical data analytics or data science within the Pharma/Healthcare domain . Strong expertise in Advanced SQL : CTEs, Window Functions (RANK, DENSE_RANK, PARTITION BY), joins, subqueries. Experience working with EMR/EHR systems such as Epic, Cerner, Meditech, etc. Proficiency in Python, R , or SAS for statistical and machine learning modeling. Strong knowledge of clinical trial design , ICD/CPT coding , MedDRA , and pharmacovigilance datasets. Hands-on with machine learning frameworks (Scikit-learn, XGBoost, etc.) for prediction and classification tasks. Familiarity with regulatory guidelines such as HIPAA , GCP , and 21 CFR Part 11 . Experience with data visualization tools such as Tableau, Power BI, or Python-based dashboards . Preferred Qualifications: Master’s or Ph.D. in Data Science, Biostatistics, Bioinformatics, Public Health, or a related field . Prior experience in RWE/RWD analytics , HEOR studies , or pharma R&D analytics . Knowledge of CDISC SDTM/ADaM standards . Experience working with cloud platforms (AWS, Azure, GCP) and data lake architecture is a plus. Job Type: Contractual / Temporary Contract length: 12 months Schedule: US shift Application Question(s): What would your NP? Which location would you pick Bangalore / Chennai / Hyderabad / Noida / Gurgaon (India) Experience: Data science: 5 years (Preferred) Machine learning: 5 years (Preferred) EMR systems: 5 years (Preferred) Work Location: In person

Description Mgr, Statistical Programming Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Minimum experience: 10 yrs 5 to 6 yrs of clinical Stat Programming exp, SDTM, ADAM, TLF Client engagement, communication, Must have exp of resource management, performance management. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Mgr, Statistical Programming

The Statistical Programmer II position at Princeps Technologies in Hyderabad is a key role within our organization. As a data-driven company specializing in advanced analytics and technology solutions for the pharmaceutical and biotechnology sectors, we are dedicated to innovation, quality, and client success. As a Statistical Programmer II, you will be responsible for developing and validating SDTM datasets according to CDISC standards, creating ADaM datasets following current guidelines, and programming Tables, Listings, and Figures (TLFs) as per sponsor requirements. Your role will also involve generating subject narratives, producing clinical registry files, performing quality control on programming deliverables, and preparing electronic submission packages that adhere to global regulatory standards. The ideal candidate for this position is a SAS programmer with over 4 years of experience in clinical trial data analysis. You should be proficient in SAS Base and Macro programming, particularly for SDTM, ADaM, and TLFs, and have knowledge of clinical domains such as safety, efficacy, and PK/PD. Familiarity with CDISC standards, metadata programming, and sponsor-defined analysis standards is essential, while experience with Therapeutic Area User Guides (TAUGs) and R programming would be advantageous. To be successful in this role, you should possess strong documentation, quality control, and regulatory compliance skills. A Bachelor's or Masters degree in Statistics, Life Sciences, Computer Science, or related fields is preferred, along with experience in preparing submission-ready data and documentation. Effective communication and collaboration skills are valued, as is an understanding of regulatory expectations from agencies like the FDA and EMA. Joining Princeps Technologies means becoming part of a talented and mission-focused team dedicated to global clinical research and regulatory innovation. You will have the opportunity to work in a supportive environment with onsite collaboration in Hyderabad, along with competitive compensation and professional development prospects.,

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

1. Design and development of CV, Steering and front axle aggregates 2. knowledge Bus and load platform 3. Casting and forging manufacturing processes knowledge, 4. DMEA, DFA, DFS, DFM. 5. Knowledge of DVP, 6 Hands on experience in CATIA. 6. Ability to resolve the problems, 7. Basic knowledge of vehicle dynamics ADAMs, MBD. 8. Knowledge of Homologation requirements.

Biostatistician II statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. They prepare statistical sections of protocols, including sample size calculations, annotate shell data displays, and provide specifications for the structure, content, and algorithms of status and analysis datasets. They perform and oversee quality control (QC) of data displays with inferential statistics. Statisticians report to the Biostatistics Manager. QUALIFICATIONS FOR ESSENTIAL FUNCTIONS Develop, validate, and maintain SAS programs to create analysis datasets, tables, listings, and figures (TLFs) as specified in statistical analysis plans. Design and verify randomization codes to support clinical trial integrity. Prepare statistical sections of protocols, including sample size calculations, and annotate 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 analysis datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM). Conduct independent validation of datasets created by other programmers or statisticians. Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and programming/QC documentation. Manage electronic project directories to ensure organization and accessibility of deliverables. Mentor and guide junior programmers, providing training on SAS programming and clinical data standard 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.

Location: Bangalore/ Mumbai /Hybrid/WFH Experience: 3 to 6 years Job Responsibilities: Strong oral and written communication skills Study Lead Experience and exposure on efficacy domains and TFLs is a plus Participates in the creation or validation of Case Report Forms (CRFs), CRF annotations, SDTM/ADAM specifications, datasets, Define, and TLFs. Proficiency in SAS and CDISC for programming. Ensure all statistical activities are in accordance with internal and external quality standards, SOPs/WPDs, ICH-GCP, and/or other international/local regulatory requirements. Experience in specialized therapeutic areas (TAs) such as oncology, immunology, and neurology would be a plus. Core Strength: The candidate should be technically sound and have hands-on experience in Statistical Programming. Ensures excellence and high quality in work. Problem-solving approach. Act as a good team player and quick learner.

The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects. This role supports the generation of real-world evidence (RWE) by programming and analyzing large-scale observational datasets. The ideal candidate will have strong SAS programming skills, familiarity with R, and experience working with healthcare claims, electronic health records (EHR), or registry data. Key Accountabilities Project Management: Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Statistical Programming For Assigned Projects Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings. Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation. Training Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other Parexel functional areas. Provide relevant training and mentorship to staff and project teams as appropriate. General Develop, validate, and maintain SAS and R programs to support RWD analyses, including prevalence, treatment patterns, cost/utilization, and time-to-event studies Execute programming tasks using Client standard macros and environments within UNIX and AWS-based platforms Perform double programming and quality control (QC) checks in alignment with internal SOPs and KIMS system workflows Collaborate with statisticians, data scientists, and cross-functional teams to define specifications and deliverables Document programming processes and outputs in accordance with regulatory and internal audit requirements Contribute to the development and maintenance of internal R packages, Shiny apps, and Quarto documentation to support programming workflows Participate in onboarding and mentoring of new programmers, including training on client-specific tools and data environments Skills Excellent analytical skills. Proficiency in SAS; working knowledge of R is highly desirable 3+ years of experience in statistical programming, preferably in a pharmaceutical or healthcare setting Knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Familiarity with real-world data sources such as Optum, MarketScan, Flatiron, CPRD, or similar Experience with Snowflake, UNIX/Linux environments, and version control tools (e.g., Git). Strong understanding of data privacy, regulatory compliance, and audit-readiness in RWD contexts Ability to learn new systems and function in an evolving technical environment. Ability to manage competing priorities and flexibility to change. Attention to detail. Ability to successfully work as part of a global team. Work effectively in a quality-focused environment. Effective time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Business/operational skills that include customer focus, commitment to quality management, and problem solving. Knowledge And Experience Competent in written and oral English. Good communication skills. Experience with OMOP/OHDSI standards and tools Exposure to project management tools like Monday.com Ability to work independently and manage multiple priorities in a fast-paced environment Education Educated to degree level in a relevant discipline and/or equivalent work experience; Bachelor’s or Master’s degree in Statistics, Computer Science, Epidemiology preferred.

Role & responsibilities: Collaborating closely with clients to deliver technical consulting services and configure the elluminate platform. Guiding and supporting the team of data engineers on various technical service delivery activities. 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 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. 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 standards. Performing other duties as assigned. Preferred candidate profile Education & Experience 3+ years of professional experience preferred Bachelor's degree or equivalent experience preferred Experience developing back end, database/warehouse architecture, design and development preferred Knowledge of variety of data platforms including SQL Server, DB2, Teradata, (Cloud based DB a plus) 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 Ability to work with different technical and cross functional teams Must be proactive, demonstrate initiative, and be a logical thinker Must be team oriented with strong collaboration, prioritization, and adaptability skills Good understanding of technical challenges and capability to analyze requirement and technical problems Excited to learn new tools and product modules and adapt to changing technology and requirements Excellent knowledge of English; verbal and written communication skills 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 Click the link below to apply https://grnh.se/esmhken67us

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Job Title: Statistical Programmer II (SDTM) Location : Chennai/ Bangalore/ Trivandrum What You Will Be Doing Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc. Review and provide input into all trial set-up documentation Translate protocol and any applicable de-risking into the creation and maintenance of detailed technical specifications, mapping documentation including aCRF, data transfer agreements, as applicable, etc. Creation of Data Review Model (DRM) based on current standards and SDTM datasets based on current SDTM standards Creation of back-end edit checks, listings, and visualizations to support risk-based central monitoring, e.g., Quality Tolerance Limits (QTLs), Critical to Quality (CtQ), etc., and ongoing clinical and safety data review QC of all clinical programming deliverables Perform unblinding, data-cut activities for planned reporting milestones and database locks Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA, and other regulatory agencies as needed. Support the development of standards and drive implementation within the organization You Are Minimum 4+ years of experience In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., SAS, SQL, Python, R, etc.) Strong knowledge of complex finding data types, including but not limited to biomarkers, and digital data such as ECG, imaging, etc. In-depth knowledge of SDTM including Define.xml, CDASH, and metadata as well as experience transforming transferred vendor data into SDTM preferred, knowledge of AdaM a plus Experience utilizing tools intended for report writing, analytics, visualizations, or dashboard creation (e.g., Spotfire, Tableau, Qlik, JReview, Business Objects, Oracle BI, etc.) to support ongoing clinical data and safety review What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

The ideal candidate for the Senior Statistical Programming position should have a minimum of 3-8 years of experience. You should possess a strong understanding of SAS Base/Macros/GTL and have hands-on experience in SDTM/ADAM/TLFs creation following CDISC standards. Your expertise should lie in both Base and Advance SAS programming. You will be responsible for developing complex SAS macros that can be applied across Therapeutic Areas in various studies. Additionally, your role will involve reviewing the SAS programs that have been developed. Proficiency in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components is crucial for this position. As a Senior Statistical Programmer, your primary duties will revolve around SAS programming within the pharmaceutical industry. Therefore, a Bachelor's degree in a related field is required for this full-time, permanent position. Key Skills: - SAS - SDTM - ADAM - TLF - Statistical Analysis If you meet the above requirements and are ready to take on this challenging role, we encourage you to apply using the Job Code: GO/JC/551/2025. For any queries regarding the position, you may reach out to the Recruiter, Sangeetha Tamil.,

As a Data Standards Specialist at ICON plc, you will play a crucial role in supporting the standardization of data management practices. Your primary responsibility will involve creating and maintaining content in the Data Standards Catalog under guided supervision. You will collaborate with representatives from various functions, leveraging industry standards to develop clinical data collection instruments and associated checks. Your role will also involve updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. Participation in relevant governance team meetings and providing input on standards as assigned will be essential. Collaborating with Senior/Principal Data Standards Specialists or Managers to implement data standards strategy, ensuring compliance with regulations and internal governance procedures will be part of your responsibilities. As a subject matter expert (SME) for specific topics, you may provide ongoing support to the Data Management organization and key stakeholders such as Clinical, Biostatistics, Medical, and Medical Writing departments. Additionally, you will contribute to Data Management or cross-functional initiatives as needed and oversee CRO/FSP data managers and/or database development teams. You will represent the Data Standards team in various forums, including Data Standards Governance meetings, Clinical study team meetings, and Project update meetings. Demonstrating a foundational knowledge of Data Management and Data Standards processes, along with an awareness of industry best practices, is key to excelling in this role. Having a basic understanding of regulations like 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection is required. An ideal candidate would have a minimum of 2 years of clinical data standards experience in the biotechnology, pharmaceutical, or health-related industry. Possessing CDISC standards, SCDM certification, or Medidata RAVE certification is considered a plus. The role requires a Bachelor's degree in a Science, Health, Computing, or related field. At ICON, we value our employees and offer a competitive salary along with a range of benefits designed to promote well-being and work-life balance. Our benefits include various annual leave entitlements, health insurance options, retirement planning offerings, a Global Employee Assistance Programme, life assurance, and country-specific optional benefits like childcare vouchers, discounted gym memberships, and health assessments. To learn more about the benefits of working at ICON, visit our careers website at https://careers.iconplc.com/benefits. If you are interested in the role but unsure if you meet all the requirements, we encourage you to apply as you may be exactly what we are looking for at ICON, whether for this position or other roles.,

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are seeking a skilled SAS Clinical Programmer III with experience in SAS and EDC programming to join our dynamic team. In this role, you will leverage your expertise in SAS programming and clinical data management to support the analysis and reporting of clinical trial data. Your contributions will be pivotal in ensuring the accuracy and integrity of our clinical databases. As a Clinical Programmer III at Allucent You will lead and coordinate clinical programming activities and maintaining clinical databases and other application tools supporting data capture and data processing in compliance with study-specific plans, standard operating procedures, industry standards and regulatory requirements. You will be part of a small but nimble global team. Credibility, quality and collaborations are the key pillars that drive this team. We are looking for you to come with an innovative and can-do-approach where you can have a quick impact. In this role your key tasks will include: Design, build, test and release clinical databases to the production environment, including study design specifications, User's Acceptance Test (UAT) test cases and database configuration settings in support of database set-up and edit checks programming. You will work with SAS and EDC programming. Review electronic Case Report Form (eCRF) Completion guidelines Develop and/ or validate SAS programs for metric reporting, data review listings, data import and data export set-up Support application of Clinical Data Interchange Standards Consortium (CDISC) conventions during database build activities and data warehousing, i.e. CDASH, TAUGs and SDTM models Review and adhere to the requirements of study-specific data management documents & plans Actively contribute/participate in study team, departmental meetings, sponsor meetings and uses analytical approach to problem solving Collaborate with peers, programmers, study teams to clarify specifications and uses expanded technical skills to meet evolving project needs Maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading literatures, self-training, attending training classes, professional meetings etc. Research and propose initiatives for improving efficiency Develops and delivers applicable DM departmental trainings Draft and contribute as Subject Matter Expert (SME) in the field of Clinical Programming activities to the evaluation/improvement of processes and procedures within the Quality Management System Requirements To be successful you will possess: You bring a minimum of 2-5 years of relevant work experience in a clinical research and/or drug development organization combined with a degree in Life science and experience in SAS and EDC programming. Computer Science, healthcare and/or related field degree. You will be a great addition to the team when you are open and transparent, work well together and have a solution focused approach. To be successful we are looking for the following traits and behaviors: Good knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (local) regulatory requirements. Good understanding of clinical data management processes and experience with tools and systems for managing clinical studies. Solid understanding and hands-on experience with CDISC standards (i.e. CDASH, TAUGs and SDTM models). Strong programming SAS skills with proficiency in Electronic Data Capture (EDC) systems, data reporting and programming languages such as PL/SQL, SAS and comparable fields. Ability to work in a fast-paced challenging environment of a growing company. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/office-based* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices . "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

Job Title: Statistical Programmer II Experience: 4+ Years Location: Hyderabad (Onsite) Employment Type: Full-Time About Princeps Technologies: Princeps Technologies is a data-driven organization delivering advanced analytics and technology solutions to the pharmaceutical and biotechnology industries. We are committed to innovation, quality, and client success. Role Overview: We are seeking a skilled Statistical Programmer II to join our team onsite in Hyderabad. The ideal candidate will have hands-on experience with SDTM and ADaM programming, TLF generation, and regulatory submission support within the clinical trial space. Key Responsibilities: Develop and validate SDTM datasets based on CDISC standards. Create ADaM datasets in accordance with current ADaM implementation guidelines. Program Tables, Listings, and Figures (TLFs) as per sponsor requirements. Generate subject narratives using approved templates. Produce clinical registry files (e.g., ClinicalTrials.gov, EudraCT) and BIMO reports . Perform quality control (QC) and validation of all programming deliverables. Prepare and maintain specification documentation for datasets and outputs. Develop electronic submission packages that comply with global regulatory standards (FDA, EMA, etc.). Support data integration across studies for submission and cross-study analysis. You Are: A SAS programmer with 4+ years of experience in clinical trial data analysis. Proficient in SAS Base and Macro programming , especially for SDTM, ADaM, and TLFs. Familiar with clinical domains such as safety , efficacy , and PK/PD . Knowledgeable of CDISC standards (ADaM, SDTM, Controlled Terminologies). Experienced in metadata programming and following sponsor-defined analysis standards. Exposure to Therapeutic Area User Guides (TAUGs) is a plus. R programming experience is an added advantage. Strong in documentation, QC, and regulatory compliance. Preferred Qualifications: Bachelor's or Master’s degree in Statistics, Life Sciences, Computer Science , or related fields. Experience in preparing submission-ready data and documentation. Working knowledge of regulatory expectations from agencies like FDA and EMA. Effective communication skills and a collaborative mindset. Why Join Princeps Technologies? Join a talented and mission-focused team. Contribute to global clinical research and regulatory innovation. Enjoy a supportive work environment with onsite collaboration in Hyderabad. Competitive compensation and professional development opportunities .

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. 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.

Job Description Biostatistician II statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. They prepare statistical sections of protocols, including sample size calculations, annotate shell data displays, and provide specifications for the structure, content, and algorithms of status and analysis datasets. They perform and oversee quality control (QC) of data displays with inferential statistics. Statisticians report to the Biostatistics Manager. Qualifications For Essential Functions Develop, validate, and maintain SAS programs to create analysis datasets, tables, listings, and figures (TLFs) as specified in statistical analysis plans. Design and verify randomization codes to support clinical trial integrity. Prepare statistical sections of protocols, including sample size calculations, and annotate 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 analysis datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM). Conduct independent validation of datasets created by other programmers or statisticians. Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and programming/QC documentation. Manage electronic project directories to ensure organization and accessibility of deliverables. Mentor and guide junior programmers, providing training on SAS programming and clinical data standard 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.

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 Principal 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 This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials. Responsibilities As a Principal Statistical Programmer, your responsibilities will include: Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs Participate in overseeing CRO’s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions. Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros Participate in the development of CRFs, edit check specifications, and data validation plans Provide review and/or author data transfer specifications for external vendor data Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices 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: At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities Must be able to work independently Outstanding communication skills (written and verbal) and strong leadership skills Preferred Qualifications (nice To Have) Prior work experience with pharmacokinetic data and the neuroscience field, proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)

Bangalore Karnataka India; Chennai Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5838 Position Summary: The Clinical Data Manager/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs. Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing May perform quality control of data entry Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Coordinate SAE/AE reconciliation Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings May review Request for Proposals (RFP), proposals, provide project estimates Provide leadership for cross-functional and organization-wide initiatives, where applicable Trains and ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications: Minimum Required: Bachelors and/or a combination of related experience Other Required: 10+ years’ experience Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Professional use of the English language; both written and oral Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices Strong representational skills, ability to communicate effectively orally and in writing Strong leadership and interpersonal skills Ability to undertake occasional travel Preferred: Experience in a clinical, scientific or healthcare discipline Dictionary medical coding (MedDRA and WHODrug) Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) Oncology and/or Orphan Drug therapeutic experience It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2021 Precision Medicine Group, LLC. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

ICON plc is driving efficiencies through standardizing data management practices. As a Data Standards Specialist, you will play a crucial role in creating and maintaining content in the Data Standards Catalog. Working under guided supervision, you will collaborate with representatives from various functions to develop clinical data collection instruments and checks using industry standards. Your responsibilities will include updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. You will actively participate in governance team meetings, providing input on assigned standards. Collaborating with Senior/Principal Data Standards Specialists or Managers, you will help implement data standards strategy while ensuring compliance with regulations and internal governance procedures. In addition, you may serve as a subject matter expert (SME) for specific topics. You will offer ongoing support to the Data Management organization and key stakeholders such as Clinical, Biostatistics, Medical, and Medical Writing teams. Your role may also involve contributing to Data Management or cross-functional initiatives as required. Furthermore, you might oversee and hold accountable CRO/FSP data managers and/or database development teams. As part of the Data Standards team, you will represent ICON in various forums including Data Standards Governance meetings, clinical study team meetings, and project update meetings. To be successful in this role, you should demonstrate a foundational knowledge of Data Management and Data Standards processes, along with an understanding of industry best practices. A basic understanding of regulations such as 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards is required. Possession of CDISC standards, SCDM certification, or Medidata RAVE certification will be advantageous. A minimum of 2 years of clinical data standards experience in biotechnology, pharmaceutical, or health-related industry is necessary. Education-wise, a Bachelor's degree in a Science, Health, Computing, or related field is required. At ICON, we value our people and strive to build a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, we offer a range of benefits tailored to promote well-being and work-life balance for you and your family. Our benefits include various annual leave entitlements, health insurance options, retirement planning offerings, a Global Employee Assistance Programme, life assurance, and country-specific optional benefits like childcare vouchers, gym memberships, and health assessments, among others. If you are interested in the role but unsure if you meet all requirements, we encourage you to apply as you may be exactly what we are looking for at ICON. Visit our careers website to learn more about the benefits of working with us: https://careers.iconplc.com/benefits For more information about reasonable accommodations, visit: https://careers.iconplc.com/reasonable-accommodations,

Position Overview We are seeking an experienced SAS Programmer - Pharmaceutical to join our clinical programming team. The successful candidate will be responsible for developing, testing, and maintaining SAS programs for clinical trial data processing, CDISC dataset creation, and regulatory submission deliverables in compliance with pharmaceutical industry standards. Key ResponsibilitiesSAS Programming & Development Develop and maintain complex SAS programs for clinical trial data processing and transformation Create SDTM (Study Data Tabulation Model) datasets from raw clinical data Build ADaM (Analysis Data Model) datasets for statistical analysis Generate tables, listings, and figures (TLFs) using SAS procedures Develop reusable SAS macros and standard programming libraries Optimize SAS code for performance and efficiency Data Processing & Validation Transform and clean clinical trial data using SAS DATA steps and procedures Implement data validation checks and quality control processes Create and maintain data derivation specifications and programming documentation Perform dataset reconciliation and data integrity checks Debug and troubleshoot SAS programs to ensure accurate outputs CDISC Implementation Implement CDISC standards (SDTM, ADaM) using SAS programming Create and maintain CDISC-compliant datasets for regulatory submissions Develop define.xml files and associated documentation Ensure metadata consistency across programming deliverables Support CDISC validation and compliance reviews Regulatory Support Prepare SAS programs and datasets for regulatory submissions (NDA, BLA, IND) Ensure programming deliverables meet FDA, EMA, and other regulatory requirements Support regulatory inspections by providing programming documentation Maintain 21 CFR Part 11 compliance in all programming activities Create and maintain programming specifications and validation documentation Technical Collaboration Work with biostatisticians to understand analysis requirements and specifications Collaborate with data managers on database design and data transfer processes Support clinical teams with ad-hoc programming requests and data queries Participate in UAT (User Acceptance Testing) and validation activities Provide technical guidance to junior programmers Required QualificationsTechnical Skills Advanced proficiency in SAS programming (Base SAS, SAS/STAT, SAS/GRAPH, SAS Macro) Strong experience with SAS DATA steps, procedures, and functions Proficiency in SQL and database programming Experience with CDISC standards implementation (SDTM, ADaM) Knowledge of clinical trial data structures and pharmaceutical data flows Understanding of regulatory requirements for pharmaceutical submissions Experience Bachelor's degree in Computer Science, Statistics, Mathematics, or related field 3-5 years of SAS programming experience in pharmaceutical/biotech environment Hands-on experience with clinical trial programming and CDISC datasets Experience with regulatory submission programming deliverables Knowledge of clinical research processes and Good Clinical Practice (GCP) Programming Competencies Expertise in SAS macro programming and automation Experience with complex data manipulations and transformations Proficiency in creating and maintaining programming documentation Strong debugging and troubleshooting skills Experience with version control systems and programming best practices Preferred QualificationsAdvanced Technical Skills Experience with SAS Enterprise Guide, SAS Studio, or SAS Viya Knowledge of other programming languages (R, Python, SQL) Experience with cloud-based SAS environments (AWS, Azure) Familiarity with clinical data standards beyond CDISC (HL7 FHIR, etc.) Experience with automated testing and validation frameworks Industry Experience Experience across multiple therapeutic areas and study phases Knowledge of adaptive trial designs and complex study protocols Experience with global regulatory submissions and requirements Familiarity with electronic submission formats (eCTD, STDM) Experience with clinical trial management systems and EDC platforms Certifications SAS Certified Base Programmer SAS Certified Advanced Programmer CDISC certification (preferred) Technical EnvironmentSAS 9.4 or SAS Viya platform Windows/Linux server environments Oracle, SQL Server, or other enterprise databases Version control systems (Git, SVN) Clinical trial management and EDC systems Working ConditionsHybrid/remote work flexibility Collaborative programming team environment Project-based work with varying deadlines Occasional overtime during submission timelines Professional development and training opportunities

JD FOR R Programmer Title- Statistical Programmer/Sr. Statistical Programmer -R Programming We are seeking an experienced R Programmer to support Application development and statistical programming activities . The ideal candidate will have strong R programming skills with a solid understanding of clinical trial data, regulatory standards (e.g., CDISC, SDTM, ADaM), and open source libraries. Key Responsibilities: Develop and validate R programs to support CDISC dataset and statistical graph Create Markdown and Shiny appy for generating statistical tables and listings. Automate and streamline data wrangling, transformation, and visualization of clinical datasets using R and associated packages. Create and maintain Shiny apps, R Markdown reports, and automated pipelines for exploratory and statistical analyses. Collaborate with biostatisticians, data managers, and clinical teams to interpret clinical data and support study objectives. Contribute to statistical analysis plans (SAPs) and documentation for regulatory submissions (e.g., FDA, EMA). Ensure compliance with GxP, 21 CFR Part 11, and company SOPs in statistical programming deliverables. Required Qualifications: Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Engineering or Quantitative field. 5+ years of experience in R programming within a clinical trials or pharmaceutical environment. Proficient in R packages such as tidyverse, haven, ggplot2, shiny, TEAL , knitr, and data.table. Knowledge of CDISC standards (SDTM, ADaM) and regulatory submission requirements. Experience with clinical data standards and regulatory documentation. Excellent attention to detail, problem-solving skills, and communication abilities. What We Offer: Opportunity to work on cutting-edge drug development programs. Career growth and access to global clinical research networks. Competitive salary and comprehensive benefits package.

Senior Clinical Data Manager - Location: Bangalore Karnataka India; Chennai Bangalore Karnataka India; Chennai Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5838 Position Summary The Clinical Data Manager/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs. Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing May perform quality control of data entry Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Coordinate SAE/AE reconciliation Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings May review Request for Proposals (RFP), proposals, provide project estimates Provide leadership for cross-functional and organization-wide initiatives, where applicable Trains and ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications Minimum Required: Bachelors and/or a combination of related experience Other Required 10+ years’ experience Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Professional use of the English language; both written and oral Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices Strong representational skills, ability to communicate effectively orally and in writing Strong leadership and interpersonal skills Ability to undertake occasional travel Preferred Experience in a clinical, scientific or healthcare discipline Dictionary medical coding (MedDRA and WHODrug) Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) Oncology and/or Orphan Drug therapeutic experience It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now

Position Summary The Clinical Data Manager/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs. Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing May perform quality control of data entry Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Coordinate SAE/AE reconciliation Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings May review Request for Proposals (RFP), proposals, provide project estimates Provide leadership for cross-functional and organization-wide initiatives, where applicable Trains and ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications Minimum Required: Bachelors and/or a combination of related experience Other Required 10+ years’ experience Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Professional use of the English language; both written and oral Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices Strong representational skills, ability to communicate effectively orally and in writing Strong leadership and interpersonal skills Ability to undertake occasional travel Preferred Experience in a clinical, scientific or healthcare discipline Dictionary medical coding (MedDRA and WHODrug) Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) Oncology and/or Orphan Drug therapeutic experience Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Position Summary: The Clinical Data Manager/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs. Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing May perform quality control of data entry Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Coordinate SAE/AE reconciliation Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings May review Request for Proposals (RFP), proposals, provide project estimates Provide leadership for cross-functional and organization-wide initiatives, where applicable Trains and ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications: Minimum Required: Bachelors and/or a combination of related experience Other Required: 10+ years' experience Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Professional use of the English language; both written and oral Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices Strong representational skills, ability to communicate effectively orally and in writing Strong leadership and interpersonal skills Ability to undertake occasional travel Preferred: Experience in a clinical, scientific or healthcare discipline Dictionary medical coding (MedDRA and WHODrug) Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) Oncology and/or Orphan Drug therapeutic experience Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Position Summary: The Clinical Data Manager/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs. Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing May perform quality control of data entry Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Coordinate SAE/AE reconciliation Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings May review Request for Proposals (RFP), proposals, provide project estimates Provide leadership for cross-functional and organization-wide initiatives, where applicable Trains and ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications: Minimum Required: Bachelors and/or a combination of related experience Other Required: 10+ years' experience Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Professional use of the English language; both written and oral Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices Strong representational skills, ability to communicate effectively orally and in writing Strong leadership and interpersonal skills Ability to undertake occasional travel Preferred: Experience in a clinical, scientific or healthcare discipline Dictionary medical coding (MedDRA and WHODrug) Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) Oncology and/or Orphan Drug therapeutic experience Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.