529 Biostatistics Jobs - Page 13

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 Direct the development and maintenance of the required systems, infrastructure, and personnel to enable reliable, cost effective, automation and machine learning solutions available within SDC and to external partners and clients. Ensure systems and applications have appropriate validation documentation in place according to standard operating procedures. Maintain portfolio of requested and completed applications, including metrics around resource needs (internal and external to DI&A), and intended goal of the application to enable discussion around prioritization. Develop agile development practices on large initiatives to ensure alignment with the specific company goals. Participate in the identification of cross department company goals and initiatives. Oversee the continued effort to clean, process, store and analyze clinical data with its application towards research and development of Artificial Intelligence (AI) and Machine Learning (ML) algorithms supporting better understanding of the safety and efficacy of new therapies. Contribute to the organization's strong drive to be at forefront of using AI in clinical trials to simplify data processing and discover imperceptible correlations. Lead and manage software development activities to drive automation across SDC departments reducing error and increasing efficiency across those departments. Serve as the primary point within the company driving standardization. Primary Responsibilities Oversee day to data activities involving data science, data engineering, automation, and business intelligence Develop standard metrics demonstrating model performance, robustness, and validity Engage with various internal departments such as data management, technology solutions, biostatistics, statistical programming, project management, IT, and business development to strategically identify areas to apply AI and/or ML toward increasing the efficiency of processes and detecting information trends Ensure that algorithms can be practically deployed with minimal resource usage and maximum ease of use in existing architecture Oversee the delivery of high-quality software design documentation Develop ML models which autonomously identify inconsistent information in patient data and discover the correlations between patient data and medically relevant conditions such as a specific adverse event or high efficaciousness Prototype new ideas/technologies to create proof of concept and demos Develop standard operating procedures for the use of artificial intelligence within clinical trials Develop and communicate roadmap of activities and updates quarterly to executive management Ensure timelines and delivery are met and raise issues early for any risks 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 Experience with an AI framework such as{​{:}} Tensorflow, MXNet, Theano, Keras, Pytorch, Caff e Experience in Pytho n Experience in the software development process{​{:}} Evidence of delivering production level co de Familiarity with AI algorithms for problems, including natural language processing, classification, clustering, dimensionality reduction, anomaly detecti on Experience in applying AI to biomedical data analysis preferr ed Ability to develop and deliver presentatio ns Ability to communicate effectively in writing and verbal ly Ability to identify issues, present problems, and implement solutio ns Capability of communicating technical concepts clearly, concisely, and understandably to non-technical colleagu es Good leadership, organizational and time management skills, with the ability to multi-ta sk Strong interpersonal communication and presentation skil lsEducation Or Equivalent Experien ce A Master's degree in information and data science, operations research, mathematics, statistics, computer science or other related field, with focus in artificial intelligence preferred, and at least 7+ years of relevant professional experience or a Bachelor's degree with 10+ years of relevant professional experien ceBenefi tsWhy S DCSDC 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 industr y. 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 benefi ts We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitme nt We strive to provide a place of belonging to our employees with fun and engaging activities from SDC's culture cl ub 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 indust ry With a proven track record, SDC has been successfully executing client clinical programs since 20 05Take a look at how you can join our tea m!

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

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

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

Ct HR Lavanya - 9566157632 Medical Coding is the process of converting patient health information into alpha numeric codes. Coders take medial reports from doctors, which may include a patients condition, the doctors diagnosis, a prescription, and whatever procedures the doctor or healthcare provider performed on the patient, and turn that into a set of codes, which make up a crucial part of the medical claim. Eligibility: All (UG/PG) Life Science& Paramedical Graduates BDS BPT BHMS BAMS Siddha,Unani,Naturopathy {Dip Bsc Msc} Nursing/GNM {B.E M.E} Biomedical Engineering {B.tech,M.tech}Biotechnology Biochemistry Bioinformatics Microbiology Zoology and Advanced zoology Biology Botany Medical Lab Tech Plant biotechnology Pharmacy(B.Pharm M.pharm) Paramedical Physiotherapy Physician assistant Critical Care Technology Medical Biochemistry Medical Record Science Operation Theatre & Anaesthesia Technology {Bsc Msc Dip} Clinical Nutrition Human Genetics Medical Laboratory Technology Medical Sociology Epidemiology Molecular Virology Biostatistics Blood Banking Technology Regenerative Medicine Optom. Genetic Counseling Radiology & Imaging Technology Medical Biochemistry Medical Microbiology Clinical Care Technology Clinical Care Technology Medical Physics {Bsc Msc Dip} Accident & Emergency Care Technology Audiology & speech Language Pathology Cardiac Technology Cardio Pulmonary Perfusion Care Technology Critical Care Technology Dialysis Technology Neuro Electrophysiology Medical Sociology Nuclear Medicine Technology Operation Theatre & Anaesthesia Technology Optometry Physician Assistant Radiology Imaging Technology Radiotherapy Technology Medical Record Science Respiratory Therapy Fitness and Lifestyle Modifications Accident & Emergency Care Technology Critical Care Technology Nursing Aide Operation Theatre & Anaesthesia Technology Ophthalmic Nursing Assistant Medical Record Science Optometry Technology Radiology & Imaging Technology Medical Lab Technology Cardiac Non Invasive Technology Dialysis Technology Dentist Requirement: Knowledge in Anatomy and Physiology Good communication and interpersonal skills Basic Computer Skills Benefits System based job Weekly 5 days duty Day shift with Sat and Sun off Food and Cab provided by company Incentives based on performance Starting salary 12k to 25k with increment in 6 months for experienced. Abroad opportunities available Bonus for referring friends Medical expenses covered by company Provident Fund will be provided Gratuity after 5 yrs of work experience. Job Location: Chennai, Tirumala,Tirupati,Hyderabad,Vizag,Eluru,Kakinada,Ongole,Anantpur,Bhimavaram,Coimbatore, Vellore, Trichy, Cuddalore, Pondi Salem, Erode, Namakkal, Thanjavur, Nagercoil, Theni,Dindokal Thiruvannamalai, Villupuram, Karur, Tirunelveli,Kanniyakumari Tirupati, Kerala, AP,Tamilnadu,Telangana Reach Us: Ct: HR Lavanya - 9566157632

The Postdoctoral Fellow applicant will work in conjunction with the Principal Investigator to lead the Sex-Based Precision Medicine Research Core (SPMRC). The SPMRC will promote and support sex- and gender-based precision medicine (SPM) research at the Tulane Center of Biomedical Research Excellence in Sex-Based Precision Medicine (COBRE in SPM), assist Research Project Leaders (RPLs) and Pilot Project Leaders (PPLs) in obtaining independent research funding, and serve the broader scientific community by performing high-impact, sex-based biology and precision medicine (SPM) research. The study of sex and gender differences is a discipline in itself, with its own concepts and methods that apply across cells and tissues as well as clinical and population health. This critical aspect of SPM requires the use and knowledge of quantitative methods including biostatistics, epidemiology, and bioinformatics to design and analyze studies to assess the interactions of sex and gender with race, age, and social determinants of health (e.g., occupational hazards, lifestyle, social stresses, access to healthcare).

Senior Bioinformatics QA Engineer About Velsera Medicine moves too slow. At Velsera, we are changing that .Velsera was formed in 2023 through the shared vision of Seven Bridges and Pierian, with a mission to accelerate the discovery, development, and delivery of life-changing insights .Velsera provides software and professional services for :AI-powered multimodal data harmonization and analytics for drug discovery and developmen tIVD development, validation, and regulatory approva lClinical NGS interpretation, reporting, and adoption With our headquarters in Boston, MA, we are growing and expanding our teams located in different countries ! What will you do? Quality Assurance / Test Strategy & Execution Work closely with QA Team and implement QA Practices and strategies according to best practices and quality standards Understand and follow SDLC processes to meet quality goals at the product level Work as part of cross-functional scrum teams ("PODs"), developing applications using agile methodologies Provide guidance and mentor team members on test activities and bioinformatics testing approaches Collaborate with development teams to address bugs and production defects quickly Bioinformatics Testing Expertise Interpret requirements to develop verification & validation test plans for bioinformatics applications Design test cases for sequence analysis software including alignment, variant calling, and annotation Design, create, and maintain bioinformatics data simulators and automated testing frameworks Work with product management to understand functional specifications for genomic applications Execute complex test scenarios and investigate issues in bioinformatics pipelines Documentation & Process Improvement Create comprehensive documentation to record testing phases and provide test execution reports Modify/update test protocols based on requirement changes; perform impact analysis Stay current with new testing tools and strategies in both QA and bioinformatics domains Evaluate and improve testing methodologies for continuous improvement Work with cross-functional teams to ensure quality throughout the product development lifecycle What do you bring to the table? Master's degree in Bioinformatics, Computational Biology or related field 7 + years of experience as software QA, with at least 3 years in bioinformatics or genomics Minimum 2 years working experience as a Bioinformatician or in genomic data analysis Demonstrated experience with Next Generation Sequencing tools (BWA, GATK, SAMtools, Tophat) Strong understanding of genomic data analysis, biostatistics, and data structures Experience with CI/CD pipelines and version control systems (Git) Knowledge of software engineering practices, SQA processes, and methodologies Professional Competencies Exceptional attention to detail and problem analysis abilities Strong communication skills (written and verbal) Ability to absorb complex information and integrate it into testing methodologies Focus on quality and continuous improvement Strategic vision to anticipate testing needs for emerging technologies Persuasiveness in advocating for quality standards and practices Experience in the medical device or life sciences industry Knowledge of handling/processing large genomic datasets Experience with cloud computing platforms (AWS, Azure, GCP) Experience with Docker and containerized applications Understanding of regulatory requirements for clinical software (HIPAA, FDA) Strong expertise in QA automation tools and frameworks (Selenium, RestAssured, Jenkins) Proficiency in Java and at least one scientific scripting language (Python/Java) Benefits Flexible Work & Time Off - Embrace hybrid work models and enjoy the freedom of unlimited paid time off to support work-life balance. Health & Well-being - Access comprehensive group medical and life insurance coverage, along with a 24/7 Employee Assistance Program (EAP) for mental health and wellness support. Growth & Learning - Fuel your professional journey with continuous learning and development programs designed to help you upskill and grow. Recognition & Rewards - Get recognized for your contributions through structured reward programs and campaigns. Engaging & Fun Work Culture - Experience a vibrant workplace with team events, celebrations, and engaging activities that make every workday enjoyable. & Many More...

Ct HR Lavanya - 9566157632 Medical Coding is the process of converting patient health information into alpha numeric codes. Coders take medial reports from doctors, which may include a patients condition, the doctors diagnosis, a prescription, and whatever procedures the doctor or healthcare provider performed on the patient, and turn that into a set of codes, which make up a crucial part of the medical claim. Eligibility: All (UG/PG) Life Science& Paramedical Graduates BDS BPT BHMS BAMS Siddha,Unani,Naturopathy {Dip Bsc Msc} Nursing/GNM {B.E M.E} Biomedical Engineering {B.tech,M.tech}Biotechnology Biochemistry Bioinformatics Microbiology Zoology and Advanced zoology Biology Botany Medical Lab Tech Plant biotechnology Pharmacy(B.Pharm M.pharm) Paramedical Physiotherapy Physician assistant Critical Care Technology Medical Biochemistry Medical Record Science Operation Theatre & Anaesthesia Technology {Bsc Msc Dip} Clinical Nutrition Human Genetics Medical Laboratory Technology Medical Sociology Epidemiology Molecular Virology Biostatistics Blood Banking Technology Regenerative Medicine Optom. Genetic Counseling Radiology & Imaging Technology Medical Biochemistry Medical Microbiology Clinical Care Technology Clinical Care Technology Medical Physics {Bsc Msc Dip} Accident & Emergency Care Technology Audiology & speech Language Pathology Cardiac Technology Cardio Pulmonary Perfusion Care Technology Critical Care Technology Dialysis Technology Neuro Electrophysiology Medical Sociology Nuclear Medicine Technology Operation Theatre & Anaesthesia Technology Optometry Physician Assistant Radiology Imaging Technology Radiotherapy Technology Medical Record Science Respiratory Therapy Fitness and Lifestyle Modifications Accident & Emergency Care Technology Critical Care Technology Nursing Aide Operation Theatre & Anaesthesia Technology Ophthalmic Nursing Assistant Medical Record Science Optometry Technology Radiology & Imaging Technology Medical Lab Technology Cardiac Non Invasive Technology Dialysis Technology Dentist Requirement: Knowledge in Anatomy and Physiology Good communication and interpersonal skills Basic Computer Skills Benefits System based job Weekly 5 days duty Day shift with Sat and Sun off Food and Cab provided by company Incentives based on performance Starting salary 12k to 25k with increment in 6 months for experienced. Abroad opportunities available Bonus for referring friends Medical expenses covered by company Provident Fund will be provided Gratuity after 5 yrs of work experience. Job Location: Chennai, Tirumala,Tirupati,Hyderabad,Vizag,Eluru,Kakinada,Ongole,Anantpur,Bhimavaram,Coimbatore, Vellore, Trichy, Cuddalore, Pondi Salem, Erode, Namakkal, Thanjavur, Nagercoil, Theni,Dindokal Thiruvannamalai, Villupuram, Karur, Tirunelveli,Kanniyakumari Tirupati, Kerala, AP,Tamilnadu,Telangana Reach Us: Ct: HR Lavanya - 9566157632

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies. Key Responsibilities The job tasks listed below outline the scope of the position. Based on current business needs, the application of these tasks may vary. Statistical Trial Design and Analysis Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study. Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created. Collaborate with data management in the planning and implementation of data quality assurance plans. Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected. Participate in peer-review work products from other statistical colleagues. Communication of Results and Inferences Collaborate with team members to write reports and communicate results. Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings. Respond to regulatory queries and to interact with regulators. Therapeutic Area Knowledge Understand disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor. Regulatory Compliance Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training. Minimum Qualification Requirements M.S. or Ph.D. in Statistics or Biostatistics or equivalent with more than 3 Years of relevant experience Other Information/Additional Preferences Statistics, Biostatistics, or equivalent of field study Proficient in the SAS programming language Interpersonal communication skills for effective customer consultation Teamwork and leadership skills Technical growth and application with working knowledge of experimental design and statistics Self-management skills with a focus on results for timely and accurate completion of competing deliverables Resource management skills Creativity and innovation Demonstrated problem-solving ability and strategic thinking Business process expertise associated with critical activities (e.g. regulatory submissions) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Data Analytics & Computational Sciences Job Sub Function Biostatistics Job Category Scientific/Technology All Job Posting Locations: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description Job Description Position Summary The Senior Statistical Programming Lead is an experienced Statistical Programmer with advanced knowledge of statistical programming methods, languages and data structures and capabilities in leading analysis and reporting activities and programming teams in accordance to departmental processes and procedures. This position is accountable for the planning, oversight and delivery of statistical programming activities supporting one or more clinical projects, compounds and/or submissions generally of low-medium complexity/criticality. The Senior Statistical Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness and quality of deliverables and provide leadership, direction and technical and project specific guidance to programming teams. As an experienced Statistical Programmer this position applies advanced technical and problem-solving skills to complete programming activities of high complexity that may benefit multiple project teams. In addition, the Senior Statistical Programming Lead may contribute advanced knowledge and technical skills to Therapeutic Area or departmental innovation and process improvement projects. Principal Responsibilities As a Programming Lead; Accountable for Statistical Programming team delivery for one or more clinical projects generally of low to medium complexity, scope or criticality. Coordinates and supervises programming team activities and provides technical and project specific mentorship to programming team members to ensure quality and timely statistical programming deliverables in compliance with departmental processes and procedures. Develops detailed programming strategy, specifications and plans the programming deliverables for a one or more clinical projects. May act as a section lead of programming activities supporting a clinical program, compound or submission. Performs comprehensive review of, and provides input into, project requirements and documentation. Collaborates optimally with statistical programming and cross-functional team members and counterparts to achieve project goals. As applicable, coordinates statistical programming activities outsourced to third party vendors adopting appropriate processes and methods to ensure their performance meets the agreed upon scope, timelines, and quality. As an experienced Statistical Programmer; Designs and develops programs in support of sophisticated clinical data analysis and reporting activities. Applies technical and analytical expertise to develop and implement solutions for use on clinical projects leading to increased efficiency and quality. May contribute to or lead others in an area of expertise that results in solutions growing the efficiency and quality of deliverables across multiple projects. May play the role of a Therapeutic/Disease Area Expert contributing to standards strategy and definition and providing expertise for a specific Therapeutic/Disease area across value streams. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Principal Relationships Reports into people manager position within the functional area. Accountable to the Statistical Programming Portfolio Lead for assigned programming activities and responsibilities. Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Statistical Programmers, peer groups within the function, Data Management, Regulatory Medical Writing. Functional contacts within Janssen (as collaborator or peer) include but are not limited to Clinical Trial Lead, Quantitative Sciences, Biostatisticians, Regulatory, Clinical - Primary interfaces within clinical project (trial), program, and submission teams. External contacts include but are not limited to external partners including CROs. Qualifications - External Bachelor's degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth). Approximately 6-8 years programming experience with growing responsibility, preferably in a pharmaceutical/clinical trial environment. Advanced knowledge of relevant statistical programming languages including SAS (required), other relevant programming languages (e.g. R, Python etc. preferred), and data structures. Proven experience planning and coordinating programming activities and leading teams. Proven experience working with cross functional stakeholder and teams. Solid understanding of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Basic project management skills. Demonstrated written and verbal communication skills. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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

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

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Key Responsibilities Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Support the electronic submission preparation and review Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and / or performs programming assignments across multiple projects with minimal supervision Support improvement initiatives Skills, knowledge, and experience Minimum Requirements: Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required. At least 5 years programming experience in industry. Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs. Have in-depth understanding of clinical data structure (e.g. CDISC standards) and relational database. Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21. Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Exposure or have working experience on real-world data or real-world evidence Preferred Requirements: Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e.g. NDA, BLA, MAA) Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements Experience or solid knowledge in other software, such as R/R-Shiny If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: Scientific/Technology All Job Posting Locations: Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, India Job Description: Principal Clinical Programming Lead Position Summary: The Principal Programming Lead is a highly skilled Programmer with expert knowledge of programming languages, tools, and complex data structures, industry standards. The position requires proven technical and analytic abilities and strong capabilities in leading activities and programming teams in accordance with departmental processes and procedures. As a highly experienced Principal Programming Lead, they apply expert technical, scientific, problem-solving skills providing innovative and forward-thinking solutions to ensure operational efficiency across assigned projects providing training, coaching, mentoring to other programmers. The Principal Programming Lead position is accountable for the planning, oversight, and delivery of programming activities in support of one or more clinical projects, compounds, or submissions of high complexity and criticality. In this role, the Principal Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables with a high degree of autonomy and provide leadership, direction and technical and project specific guidance to programming teams. In addition, this position may lead and contribute expert knowledge and technical skills to assigned delivery unit, departmental innovation, and process improvement projects. Principal Responsibilities: Designs and develops efficient programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis requests. Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes. Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed. Shares knowledge and provides guidance and coaching to programmers in developing advanced technical and analytical abilities. Performs comprehensive review of, and provides input into, project requirements and documentation. Collaborates effectively with programming and cross-functional team members and counterparts to achieve project goals and independently manages escalations. As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality. Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental technical groups and programming portfolio leads Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards. Responsible for implementation of data tabulation standards. Performs data cleaning by programming edit checks and data review listings and Data reporting by creating data visualizations and listings for medical monitoring and central monitoring. Education and Experience Requirements: Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth). Advanced degrees preferred (e.g., Master, PhD). Experience and Skills Required: Approx. 10 -12+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. In-depth knowledge of programming practices (including tools and processes). Working knowledge of relevant regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11). Project, risk, and team management and an established track record leading teams to successful outcomes. Excellent planning and coordination of project delivery. Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors.

Institute of Statistical Science Postdoctoral Researcher and/or Research Assistant Job Description Unit Institute of Statistical Science JobTitle Postdoctoral Researcher and/or Research Assistant Work Content Assist the cooperative with statistical consulting and related services. Responsible for data analysis tasks, including data preprocessing, database construction, data analysis, and report writing. Participate in various activities organized by the Institute of Statistical Science and the cooperative. Assist with administrative affairs of the cooperative. Complete other tasks assigned as needed. Qualifications Research assistant requires a master's degree, and postdoctoral researcher requires a doctoral degree in Statistics or Data Science related fields. Knowledge in "Biostatistics," "Generalized Linear Models," "Multivariate Analysis," and "Categorical Data Analysis” is required Must be familiar with programming languages such as R, SAS, Python, with experience in database development/maintenance and application being a plus. Priority given to candidates with experience in statistics and scientific computing, as well as various types of data analysis. Preference given to candidates with expertise in biostatistics or bioinformatics. Working Environment Operating Hours 08:30~17:30 Work Place Institute of Statistical Science, Academia Sinica Treatment Based on the institute's salary standards and individual qualifications and experience (starting at NT$62,776 for Ph.D. holders, NT$43,624 for master's degree holders). Reference Site http://disc.stat.sinica.edu.tw/ Acceptance Method Contacts Dr. Shu-Chun Chen Contact Address No.128, Academia Road, Section 2, Nankang, Taipei, Taiwan Contact Telephone 2783-5611 ext. 476 Email scchen@stat.sinica.edu.tw Required Documents Resume in both Chinese and English (including autobiography), transcripts from university and above, and other beneficial documents for review. Precautions for application Application Method: Interested parties, please email the required documents to scchen@stat.sinica.edu.tw. Suitable candidates will be notified for an interview. Documents will not be returned. Date Publication Date 2024-08-08 Expiration Date 2025-12-31

About Kozhnosys: Kozhnosys is a healthcare innovation startup pioneering non-invasive cancer diagnostics through exhaled breath analysis. As we expand our operations nationally, we are seeking a Clinical Trial Manager to lead the execution of our clinical studies with scientific rigor and operational excellence. Role Summary: The Clinical Trial Manager (CTM) will oversee the planning, execution, and reporting of clinical trials for Kozhnosys’ diagnostic technologies. This role requires a strategic thinker with hands-on experience in clinical operations, regulatory compliance, and cross-functional coordination. The CTM will ensure that trials are conducted in accordance with ICH-GCP, local regulations, and internal SOPs, while maintaining the highest standards of data integrity and patient safety. Key Responsibilities: Design and manage prospective and retrospective diagnostic studies. Develop clinical trial protocols, case report forms (CRFs), informed consent documents, and study manuals. Coordinate with principal investigators, CROs, and regulatory bodies to ensure timely approvals and site readiness. Oversee site selection, initiation, monitoring, and close-out activities. Travel to different site locations across India and monitor progress and compliance. Ensure compliance with ethical standards, GCP, and regulatory requirements in India, and other jurisdictions. Lead cross-functional teams including data management, biostatistics, and QA to ensure trial milestones are met. Monitor trial progress, manage risks, and implement corrective actions as needed. Prepare clinical performance evaluation reports, including sensitivity, specificity, and ROC analysis. Present trial updates to internal stakeholders, investors, and regulatory authorities. Prepare manuscripts based on study results in international journal. Apply for government grants and other funding opportunities for conducting clinical trials. Represent company in medical conferences and present the trial data. Manage team of clinical trial coordinators at different study centers. Qualifications: Master’s degree or higher in Life Sciences, Pharmacy, or related field. Minimum 5 years of experience in clinical trial management, preferably in diagnostics or medical devices. Strong knowledge of ICH-GCP, ISO 14155, and regulatory frameworks in India, Europe and North America. Experience with observational study designs and diagnostic accuracy studies. Excellent communication and stakeholder management skills. Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS). Preferred: Experience with breath-based diagnostics or sensor-based medical technologies. Certification from ACRP or SOCRA. Prior involvement in early-stage startup environments.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Key Responsibilities Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Support the electronic submission preparation and review Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and / or performs programming assignments across multiple projects with minimal supervision Support improvement initiatives Skills, knowledge, and experience Minimum Requirements Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required. At least 5 years programming experience in industry. Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs. Have in-depth understanding of clinical data structure (e.g. CDISC standards) and relational database. Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21. Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Exposure or have working experience on real-world data or real-world evidence Preferred Requirements Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e.g. NDA, BLA, MAA) Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements Experience or solid knowledge in other software, such as R/R-Shiny If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

We are looking for an experienced Data Scientist to work at one of our global biopharma customers on a range of Biostats models consulting and development engagements. They are expected to bring extensive knowledge in best practices on R package development, model development and deployment on Databricks, collaboration with version control systems, and familiarity with other topics such as data architecture and cloud infrastructure. Desired Skills and experience Candidates should have a B.E./B.Tech/MCA/MBA in Finance, Information Systems, Computer Science or a related field Strong experience in R programming and package development Proficiency with GitHub and unit testing frameworks. Strong documentation and communication skills. A background or work experience in biostatistics or a similar discipline (Preferred). Expert knowledge in Survival Analysis (Preferred) Statistical model deployment, and end-to-end MLOps is nice to have. Having worked extensively on cloud infrastructure, preferably Databricks and Azure. Shiny development is nice to have. Can work with customer stakeholders to understand business processes and workflows and can design solutions to optimize processes via streamlining and automation. DevOps experience and familiarity with software release process. Familiar with agile delivery methods. Excellent communication skills, both written and verbal Extremely strong organizational and analytical skills with strong attention to detail Strong track record of excellent results delivered to internal and external clients Able to work independently without the needs for close supervision and also collaboratively as part of cross-team efforts Experience with delivering projects within an agile environment Key responsibilities include: Evaluate and document R packages, including metadata and user-focused use cases. Develop unit tests aligned with best practices in R package development. Collaborate closely with internal stakeholders. Design and implement technical solutions for Survival Analysis, based on statistical and business requirements Develop professional quality R packages. Provide consultancy on Biostats model development and deployment best practices. Review and optimize code, integrate existing modelling code into packages. Design and implement end to end modelling and deployment process on Databricks. Support and collaborate with adjacent teams (e.g. products, IT) to integrate the modelling solution. Continually innovate with the team and the customer on using modern tooling to improve model development and deployment. Demonstrate high attention to detail, should work in a dynamic environment whilst maintaining high quality standards, a natural aptitude to develop good internal working relationships and a flexible work ethic Responsible for Quality Checks and adhering to the agreed Service Level Agreement (SLA) / Turn Around Time (TAT)

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

Summary Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level- May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e.g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External level- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Role Requirements : MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years relevant work experience Fluent English (oral and written) Good communication and presentation skills Influences decisions that directly impact the trial/project and team ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e.g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Good business ethics Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Division Development Business Unit Innovative Medicines Location India Site Hyderabad (Office) Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Clinical Data Sciences (CDS) Key to client success the Clinical Data Sciences team provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. The Clinical Data Sciences group is responsible for integrating structured and unstructured data across the various data sources, setup, data transfer/review and support downstream transformation and analysis. The Clinical Data Sciences comprises of the Clinical Data Engineering and Clinical Data Standards. While the Clinical Data Standards provides the standards for clinical operation and data flow, the Clinical Data Engineering team drives the data architecture for clinical data. CDS also provides support to exploratory and specialty data for the purposes of data modelling, simulation, and analysis. Clinical Data Configuration Specialist (CDCS), Clinical Data Sciences (CDS): Key to client success is the Clinical Data Engineering team, provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. CDCS leads the integration of collected data from all sources by setting up proper configuration of data extraction and mapping of raw data into the Common Data Model for individual studies using processes and by the Data Engineer. Work with Data Engineer to configure (Extract Transform Load)ETLs and (Extract Load and Transform)ELTs. Provide testing and documentation for data pipelines. Utilize and contribute to libraries for functions and transformation templates for reuse for study level configuration tasks. Under the guidance of Clinical Data Engineer, the Clinical Data Configuration Specialist configures and maintains the data pipelines that conform to the common data model that ensures data ingestion for all study-level data capture technologies and other related vendor and/or applications (e.g., EDC, IRT, ePRO, eCOA). Coordinates cross functionally, facilitates test data transfer, and confirms accurate DTA specification. Performs tasks to, configure, maintain, and monitor data flow integration between collected data and the clinical data repository (CDR). CDCS contributes to the successful conduct of client clinical trials and to the delivery of high quality in a timely manner, which is eventually used for statistical analysis and submitted to regulatory authorities for the approval of client products. Further, CDCS efforts enable valid secondary use of clinical trial data throughout client research groups to maximize value and achieve company objectives. Key Accountabilities: Configure data extraction and transformations in an individual contributor role across multiple data sources at the study level as defined by the Data Transfer Agreement and other specifications provided by Data Engineer Partner closely with internal/external stakeholders and data engineers in a collaborative manner Ensure accurate delivery of data format and data frequency with quality deliverables per specification Participate in the development, maintenance and training rendered by standards and other functions on transfer specs and best practices used by business Additional Activities: Assists with quality review of above activities performed by a vendor, as needed. Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. Ensure compliance with own Learning Curricula, corporate and/or GxP requirements. Performs other duties as assigned within timelines Qualifications: Bachelor's degree plus 5 years /Masters with 3 years in computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience that provides the skills and knowledge necessary to perform the job. Experience with EDC build, Data Management, and EDC extraction configuration Knowledge of data flow between clinical data management systems, vendor devices and CDR. Knowledge of XMLS, ALS, APIs and MDR preferred. Experience with one of these languages: SQL, SAS, R, Python Understanding of SDTM Strong working knowledge of clinical trial terminology and data transfer specification expected Demonstrated ability to lead projects and work groups. Strong project management skills. Proven ability to resolve problems independently and collaboratively. Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands. Ability to work independently, take initiative and complete tasks to deadlines. Special Skills/Abilities: Strong attention to detail, and organizational skills Good time management skills Quick learner and comfortable asking questions, learning new technologies and systems Good knowledge of office software (Microsoft Office). Experience with EDC build or data extraction configuration ETL/ELT experience Understanding of AWS/Data bricks concepts Preferable but not required: Experience developing R shiny and Python apps Experience with Hadoop Experience with Agile development methods Experience with Veeva CDB Supervision: Supervision required, should be able to function collaboratively (with guidance) with all levels of employees. License/Certifications: Preferred to have SAS or R or Python certification, Physical Demands: Ability to sit and stand for long periods of time. Carrying, handling, and reaching for objects. Manual dexterity to operate office equipment i.e. computers, phones, etc. Show more Show less

Role & responsibilities Programming: Proficiency in both SAS and R languages, including syntax, data manipulation techniques, and statistical modeling. Data Analysis: Experience with data extraction from various sources, cleaning, preprocessing, and statistical analysis using SAS and R. Statistical Modeling: Ability to apply various statistical models, including linear regression and mixed-effects models, in both SAS and R. Reporting and Visualization: Experience with creating reports (e.g., using Qlik or R Markdown) and visualizations to communicate findings effectively Troubleshooting: Strong analytical and problem-solving skills to troubleshoot and resolve complex issues in SAS and R code. Communication: Ability to communicate technical concepts to non-technical stakeholders effectively. Collaboration: Experience working in a team environment and collaborating with other professionals, such as biostatisticians Under moderate guidance, designs, develops, evaluates and modifies SAS and R programs to analyze and evaluate clinical data. Plans, writes and executes statistical programs in SAS and R designed to analyze data from database. Produces tables, listings and figures. Assesses data accuracy and consistency. Extract data from the SAS system and developed R scripts to clean, preprocess, and analyze data. Application of advanced statistical models, including linear regression and mixed-effects models

🚨 Vacancy Notification | Monitoring & Evaluation Officer 📍 Location: District Una, Himachal Pradesh 🗓️ Apply by: 25th June 2025 We are hiring a Monitoring & Evaluation Officer for the Pilot Scale-up Programme of WINGS Interventions in District Una, Himachal Pradesh. 📌 About the Organization: The Society for Applied Studies (SAS) is a leading public health research organization, recognized as a WHO Collaborating Centre, ICMR Centre of Excellence, and Scientific & Industrial Research Organization. Since 1990, SAS has worked in maternal and child health, nutrition, vaccine evaluation, disease surveillance, and implementation research. 🔗 https://sas.org.in 📌 About the Project – WINGS: WINGS (Women and Infants Integrated Interventions for Growth Study) has shown significant improvements in birth outcomes and early childhood development. SAS, in collaboration with the Government of Himachal Pradesh, NITI Aayog, ICMR, and BIRAC-GCI, is now implementing a pilot scale-up of the WINGS package covering health, nutrition, psychosocial care, and WaSH for women (preconception & pregnant) and young children. 👤 Position: Monitoring & Evaluation Officer 📍 Location: Una, Himachal Pradesh 🕒 Duration: Fixed term (extendable based on performance and project needs) 💰 Salary: Commensurate with experience 🎯 Key Responsibilities: Develop and manage ODK-based data systems Ensure accurate and timely data management from field operations Perform regular data quality checks and audits Conduct data extraction, cleaning, and analysis Create dashboards and contribute to progress reports and presentations Share insights with the program team to inform decisions 📘 Qualifications & Skills: Postgraduate in Biostatistics, Public Health, Epidemiology, Data Science, or a related field At least 2 years of experience in data handling, preferably in public health projects Proficiency in ODK tools, MS Excel, Stata or R Experience with data visualization tools (PowerBI, Tableau, or Looker) Excellent analytical and communication skills Ability to work in cross-functional teams and in rural field settings 📧 How to Apply: Email your updated CV to sarmila.mazumder@sas.org.in and jaideep.kumar@sas.org.in 📝 Subject line: “Application – Monitoring & Evaluation Officer – WINGS Scale-up” 🗓️ Deadline: 25th June 2025 🔁 Please help spread the word by sharing this with professionals passionate about public health, data, and rural health systems. #Hiring #MonitoringAndEvaluation #PublicHealthJobs #DataScienceJobs #ODK #Stata #PowerBI #HealthData #WINGSProject #Biostatistics #RStats #NutritionIntervention #WaSH #DevelopmentJobs #SocialImpactJobs #IndianNGOs #ResearchCareers #JoinOurTeam #ImplementationScience #EvidenceBasedPolicy #HealthSystems #DashboardDesign #FieldBasedJobs #MCH #DataForDevelopment #SocietyForAppliedStudies #HimachalPradeshJobs Let me know if you'd like a version adapted for your organization's official website or as a visual poster for sharing. Show more Show less

Job Description Position: Medical Coder Ct: HR HR Shanmugapriya - 8072891550 Medical Coding is the process of converting patient health information into alpha numeric codes. Coders take medial reports from doctors, which may include a patients condition, the doctors diagnosis, a prescription, and whatever procedures the doctor or healthcare provider performed on the patient, and turn that into a set of codes, which make up a crucial part of the medical claim. Eligibility All (UG/PG) Life Science Paramedical Graduates BDS BPT BHMS BAMS Siddha,Unani,Naturopathy {Dip Bsc Msc} Nursing/GNM {B.E M.E} Biomedical Engineering {B.tech,M.tech}Biotechnology Biochemistry Bioinformatics Microbiology Zoology and Advanced zoology Biology Botany Medical Lab Tech Plant biotechnology Pharmacy(B.Pharm M.pharm) Paramedical Physiotherapy Physician assistant Critical Care Technology Medical Biochemistry Medical Record Science Operation Theatre Anaesthesia Technology {Bsc Msc Dip} Clinical Nutrition Human Genetics Medical Laboratory Technology Medical Sociology Epidemiology Molecular Virology Biostatistics Blood Banking Technology Regenerative Medicine Optom. Genetic Counseling Radiology Imaging Technology Medical Biochemistry Medical Microbiology Clinical Care Technology Clinical Care Technology Medical Physics {Bsc Msc Dip} Accident Emergency Care Technology Audiology speech Language Pathology Cardiac Technology Cardio Pulmonary Perfusion Care Technology Critical Care Technology Dialysis Technology Neuro Electrophysiology Medical Sociology Nuclear Medicine Technology Operation Theatre Anaesthesia Technology Optometry Physician Assistant Radiology Imaging Technology Radiotherapy Technology Medical Record Science Respiratory Therapy Fitness and Lifestyle Modifications Accident Emergency Care Technology Critical Care Technology Nursing Aide Operation Theatre Anesthesia Technology Ophthalmic Nursing Assistant Medical Record Science Optometry Technology Radiology Imaging Technology Medical Lab Technology Cardiac Non Invasive Technology Dialysis Technology Dentist Requirement Knowledge in Anatomy and Physiology Good communication and interpersonal skills Basic Computer Skills Benefits System based job Weekly 5 days duty Day shift with Sat and Sun off Food and Cab provided by company Incentives based on performance Starting salary 12k to 25k with increment in 6 months for experienced. Abroad opportunities available Bonus for referring friends Medical expenses covered by company Provident Fund will be provided Gratuity after 5 yrs of work experience. Job Location: Chennai, Coimbatore, Vellore, Trichy, Cuddalore, Pondi Salem, Erode, Namakkal, Thanjavur, Nagercoil, Theni,Dindokal Thiruvannamalai, Villupuram, Karur, Tirunelveli,Kanniyakumari Tirupati, Kerala, AP,Tamilnadu,Telangana Ct: HR HR Shanmugapriya - 8072891550 This job is provided by Shine.com Show more Show less

Ct HR Lavanya - 9566157632 Medical Coding is the process of converting patient health information into alpha numeric codes. Coders take medial reports from doctors, which may include a patients condition, the doctors diagnosis, a prescription, and whatever procedures the doctor or healthcare provider performed on the patient, and turn that into a set of codes, which make up a crucial part of the medical claim. Eligibility: All (UG/PG) Life Science& Paramedical Graduates BDS BPT BHMS BAMS Siddha,Unani,Naturopathy {Dip Bsc Msc} Nursing/GNM {B.E M.E} Biomedical Engineering {B.tech,M.tech}Biotechnology Biochemistry Bioinformatics Microbiology Zoology and Advanced zoology Biology Botany Medical Lab Tech Plant biotechnology Pharmacy(B.Pharm M.pharm) Paramedical Physiotherapy Physician assistant Critical Care Technology Medical Biochemistry Medical Record Science Operation Theatre & Anaesthesia Technology {Bsc Msc Dip} Clinical Nutrition Human Genetics Medical Laboratory Technology Medical Sociology Epidemiology Molecular Virology Biostatistics Blood Banking Technology Regenerative Medicine Optom. Genetic Counseling Radiology & Imaging Technology Medical Biochemistry Medical Microbiology Clinical Care Technology Clinical Care Technology Medical Physics {Bsc Msc Dip} Accident & Emergency Care Technology Audiology & speech Language Pathology Cardiac Technology Cardio Pulmonary Perfusion Care Technology Critical Care Technology Dialysis Technology Neuro Electrophysiology Medical Sociology Nuclear Medicine Technology Operation Theatre & Anaesthesia Technology Optometry Physician Assistant Radiology Imaging Technology Radiotherapy Technology Medical Record Science Respiratory Therapy Fitness and Lifestyle Modifications Accident & Emergency Care Technology Critical Care Technology Nursing Aide Operation Theatre & Anaesthesia Technology Ophthalmic Nursing Assistant Medical Record Science Optometry Technology Radiology & Imaging Technology Medical Lab Technology Cardiac Non Invasive Technology Dialysis Technology Dentist Requirement: Knowledge in Anatomy and Physiology Good communication and interpersonal skills Basic Computer Skills Benefits System based job Weekly 5 days duty Day shift with Sat and Sun off Food and Cab provided by company Incentives based on performance Starting salary 12k to 25k with increment in 6 months for experienced. Abroad opportunities available Bonus for referring friends Medical expenses covered by company Provident Fund will be provided Gratuity after 5 yrs of work experience. Job Location: Chennai, Tirumala,Tirupati,Hyderabad,Vizag,Eluru,Kakinada,Ongole,Anantpur,Bhimavaram,Coimbatore, Vellore, Trichy, Cuddalore, Pondi Salem, Erode, Namakkal, Thanjavur, Nagercoil, Theni,Dindokal Thiruvannamalai, Villupuram, Karur, Tirunelveli,Kanniyakumari Tirupati, Kerala, AP,Tamilnadu,Telangana Reach Us: Ct: HR Lavanya - 9566157632