529 Biostatistics Jobs - Page 11

Summary The Principal Statistical Programmer is responsible for all statistical programming aspects of a large/pivotal study, several studies or project-level activities (incl. submission activities). The position is a key collaborator with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high quality deliverables in Novartis Global Drug Development. About The Role Major accountabilities: 1. Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development. 2. Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level. 3. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT). 4. Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT. 5. Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans. 6. Provide and implement statistical programming solutions; ensure knowledge sharing. 7. In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets. 8. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications. 9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. 10. Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. 11. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance 12. As assigned, act as subject matter expert (SME) or contribute to process improvement/nonclinical project initiatives with a focus on programming and analysis reporting procedures. Key Performance Indicators (Indicate how performance for this job will be measured) : Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers, including the Clinical Trial Team, Lead/Program Statistician and the functional/operational manager. Adequate representation of the Statistical Programming function as Trial/Lead/Program Programmer in the Clinical Trial Team(s). Effectiveness of communication and team behaviors as assessed by the team members. Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study/project as assessed by the functional/operational manager. Job Dimensions (Indicate key facts and figures) Number of associates: No direct reports. Coordination of 5+ internal and external programmers. Financial responsibility: (Budget, Cost, Sales, etc.) None Impact on the organization: Timely, high quality and efficiently produced statistical programming deliverables included in study and project level documents (incl. submissions) Reliable and compliant statistical analysis results presented externally (incl. submissions) Innovative technical solutions to support timely and efficient drug development deliverables Ideal Background (State the preferred education and experience level) Education (minimum/desirable): BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Languages: Fluent English (oral and written). Experience/Professional Requirement Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications Good knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures). Good communications and negotiation skills, ability to work well with others globally Experience as Trial Programmer, including coordination of internal or external programmers on a given study/project Ideally 5+years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Company Description NeoCrest Life Sciences Consulting is a professional Consulting & Services company based in New Delhi. We offer top-class Advisory & Services to Life Sciences and Healthcare Organisations, leveraging our diverse team operating in areas such as Strategy, Operations, Marketing, Data & Analytics, Medical Writing, Medical Coding, Graphic Designing, HEOR and Biostatistics. Our goal is to build long-term relationships by exceeding client expectations. Role Description This is a full-time, on-site role based in New Delhi for the position of Business Development Associate at NeoCrest. The role is ideal for someone who is proactive, detail-oriented, and passionate about the life sciences or healthcare sector. As a Business Development Associate, you will play a key role in identifying and converting new business opportunities, supporting strategic outreach, and building long-term client relationships across life sciences, pharmaceutical, hospital, and research domains. Below are some of the key areas you will be working on: • Market Research • Lead Generation • Client Communication & Outreach • CRM & Reporting • Supporting BD Campaigns • Follow-ups & Client Servicing Qualifications Background (qualification/experience) in Biology and related fields Excellent verbal & written presentation skills Efficient interpersonal skills Lead Generation and Market Research

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 . Position Summary The Senior Manager, Senior Solution Engineer, Drug Development Information Technology (DDIT) will be part of the product team committed to bridge the gap between technology and business needs within the Clinical Data Ecosystem (CDE) that primarily delivers technology strategy and solutions for clinical trial execution, Global Biostatistics and Data Sciences, Clinical Data Management (Clinical Analytics, Site Selection, Feasibility, Real Word Evidence) The role is based out of our Hyderabad office, and is part of the Research and Development (R&D) BI&T data team that delivers data and analytics capabilities for across DD. You will be specifically supporting our Clinical Data Filing and Sharing (CDFS) Product line. This is a critical role that supports systems necessary for BMS' direct value change; regulated analysis and reporting for every trial in BMS Desired Candidate Characteristics " Have a strong commitment to a career in technology with a passion for healthcare" Ability to understand the needs of the business and commitment to deliver the best user experience and adoption" Able to collaborate across multiple teams"" Demonstrated leadership experience Excellent communication skills" Innovative and inquisitive nature to ask questions, offer bold ideas and challenge the status quo" Agility to learn new tools and processes" As the candidate grows in their role, they will get additional training and there is opportunity to expand responsibilities and exposure to additional areas withing Drug Development. This includes working with Data Product Leads, providing input and innovation opportunities to modernize with cutting edge technologies (Agentic AI, advanced automation, visualization and application development techniques). Key Responsibilities Architect and lead the evolution of the Statistical Computing Environment (SCE) platform to support modern clinical trial requirements Partner with data management and statistical programming leads to support seamless integration of data pipelines and metadata-driven standards Lead the development of automated workflows for clinical data ingestion, transformation, analysis, and reporting within the SCE. Drive process automation and efficiency initiatives in data preparation and statistical programming workflows Develop and implement solutions to enhance system performance, stability and security Act as a subject matter expert for AWS SAS implementations and integration with clinical systems. Lead the implementation of cloud-based infrastructure using AWS EC2, Auto Scaling, CloudWatch, and AWS related packages Provide architectural guidance and oversight for CDISC SDTM/ADaM data standards and eCTD regulatory submissions. Collaborate with cross-functional teams to identify product improvements and enhancements. Administer production environment and diagnose & resolve technical issues in a timely manner, documenting solutions for future reference. Coordinate with vendors, suppliers, and contractors to ensure the timely delivery of products and services Serve as a technical mentor for development and operations teams supporting SCE solutions. Analyze business challenges and identify areas for improvement through technology solutions. Ensure regulatory and security compliance through proper governance and access controls. Provide guidance to the resources supporting projects, enhancements, and operations. Stay up to date with the latest technology trends and industry best practices. Qualifications & Experience Master's or bachelor's degree in computer science, information technology, or related field preferred. 15 + years of experience in software development and engineering, clinical development or data science field 8-10 years of hands-on experience working on implementing and operation of different type of Statistical Clinical Environment (SCE) with Life Sciences and Healthcare business vertical. Strong experience with SAS in an AWS-hosted environment including EC2, S3, IAM, Glue, Athena, and Lambda Hands-on development experience managing and delivering data solutions with AWS data, analytics, AI technologies such as AWS Glue, Redshift, RDS (PostgreSQL), S3, Athena, Lambda, Databricks, Business Intelligence and Visualization tools etc. Experience with R, Python, or other programming languages for data analysis or automation. Experience in shell/ Python scripting and Linux automation for operational monitoring and alerting across the environment Familiarity with cloud DevOps practices, infrastructure-as-code (e.g., CloudFormation, Terraform). Expertise in SAS Grid architecture, grid node orchestration, and job lifecycle management. Strong working knowledge of SASGSUB, job submission parameters, and performance tuning. Understanding of submission readiness and Health Authority requirements for data traceability and transparency. Excellent communication, collaboration and interpersonal skills to interact with diverse stakeholders. Ability to work both independently and collaboratively in a team-oriented environment. Comfortable working in a fast-paced environment with minimal oversight. Prior experience working in an Agile based environment. 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 About the Role: The Senior Principal Biostatistician is responsible and accountable for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. Works independently at the trial level and may lead indication or project level statistical activities for a development project under limited supervision. Proposes and leads implementation of modern and innovative trial/experimental designs, statistical models, analysis and data exploration methodologies at the study or project level. 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. Minimum requirements MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 5+ 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.

About the job Our Team: Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: The Principal Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans (SAP), programming specifications for analysis datasets and provide QC done data packages including tables, figures, and listings for use in publications (i.e., abstracts, posters, oral, presentations, manuscripts and ad-hoc data analysis requests) and to investigate the natural history of a TA diseases and long-term treatment outcomes of observational data using clinical trials and / or Registries as applicable; The Principal Biostatistician will ensure SOPs are followed, communications, timelines and quality metrics are met.; Collaboration of Local biostatistics and programming teams, Global Medical Affairs biostatisticians and / or programmers, and Global Medical Affairs Scientific Communications personnel . People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product – with an objective to develop statistical data outputs. 2) Support Sanofi Business Operations Leadership Team in understanding of stakeholders needs & expectations and provide end to end solutions for TAs/indications. 3) Coach/mentor new team members to support efficient and quick onboarding. 4) Support graduate hiring program as needed. Performance / Process: 1) Conduct appropriate post-hoc or ad-hoc statistical analyses of clinical trial data and / or registry (i.e., Observational) data. 2) Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS. 3) Produce well documented data packages that include tables, listings, and figures. 4) Work closely with the Team Lead Biostatistician and/or Team Lead Programmer to develop and implement project QC plans, timelines and KPIs. 5) Learn, implement, and share through lecture series at least one indication of disease and product (Immunology, Multiple Sclerosis and Neurology, Rare Diseases, Rare Blood Disorders and Oncology) expertise. 6) Review appropriate biomedical and clinical research literature related to assigned project(s). 7) Active participation and Effective contributing in project governance meeting to proactively discuss risks, issues related to timelines and quality of deliverables. 8) Present your selected / assigned topic in lecture series internal and / or across line functions thereby improving the statistical knowledge and presentation skills. 9) Use Advanced analytical methods & tools to provide dashboards to the stakeholders. Customer: Work closely with Global Medical Affairs biostatisticians and/or programmers to identify statistical analysis needs and assist in developing assigned deliverables About you Experience : Master's degree 8 years (M.Sc.) of experience required /Ph.D. in biostatistics or statistics or epidemiology (preferred) and 4 years. Soft skills : Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, High proficiency in statistical methods used in the pharmaceutical industry, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines. Technical skills : Advance SAS programming skills, SDTM & ADaM (CDISC) and other statistical computing software skills in a clinical data environment across multiple therapeutic areas. Education : Master of Science degree or equivalent in Statistics/ Ph.D. in biostatistics or statistics or epidemiology Languages : Excellent English language knowledge – written and spoken Pursue Progress, discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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

🩺 We’re Hiring: Experienced Healthcare & Pharma Recruiter (3+ Yrs) 📍 Locations: Hyderabad, India & Edison, NJ, USA 🕒 Full-Time | On-Site or Hybrid About Stelton Consulting: Stelton Consulting is a specialized talent solutions firm connecting top professionals with leading employers across healthcare, life sciences, and pharmaceuticals . We’re growing and looking for a Healthcare & Pharma Recruiter who can drive full-cycle recruiting across a range of high-demand roles. Your Role Will Include: • Recruiting top talent for: • Healthcare : RNs, CT Techs, Cath Lab Techs, Surgery Techs, Physicians, Surgeons • Pharma/Biotech : Regulatory Affairs, Drug Safety, Clinical Research Associates (CRAs), Clinical Data Managers • Biostatistics & Informatics : Biostatisticians, Statistical Programmers (SAS/R), Bioinformaticians • Building candidate pipelines using LinkedIn Recruiter, job portals, and referrals • Collaborating with internal teams and clients to ensure quality and speed of delivery • Managing ATS records and ensuring compliance with hiring standards What We’re Looking For: ✅ 3+ years of experience in recruiting across healthcare, life sciences, and/or pharmaceuticals ✅ Strong knowledge of roles in clinical, regulatory, and technical pharma domains ✅ Ability to screen and qualify candidates for both high-volume and niche roles ✅ Excellent communication and organizational skills ✅ Experience with US or Indian healthcare/pharma staffing preferred What You’ll Get: ✨ Competitive compensation package ✨ Work in a supportive, fast-growing company ✨ Opportunities to grow in healthcare + life sciences recruitment ✨ Join a team that values quality, innovation, and people 📧 Apply Now: Send your resume to nuvera.eman@steltonconsulting.com or Info@steltonconslting.com 🌐 Explore us at www.steltonconsulting.com

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.

About the job Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: The Team Lead Statistical Programmer will work with Medical Affairs biostatisticians and Sanofi Global Hub biostatistics and programming personnel to implement statistical analysis plans and provide QC’d data packages including tables, figures, and listings for use in publications (i.e., abstracts, posters, oral, presentations, and manuscripts); The Team Lead Statistical Programmer Provides leadership, guidance, and strategic inputs for all Sanofi Global Hub Programming personnel with different level of expertise through all projects of one or more TAs, and ensure their team members are current with advanced statistical programming techniques; The Team Lead Statistical Programmer will develop, implement, and document non-routine macros and advanced techniques; The Team Lead Statistical Programmer will ensure SOPs are followed and timelines and quality metrics are met; Secure delivery of high-quality of deliverables (TLFs) in time and in compliance with internal and external standards; Manage and ensure stakeholder’s expectations – ramping up programming teams and day to day operations to meet business requirements. People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product – with an objective to develop statistical data outputs. 2) Actively support to maintain interface between Medical Activities Hub and Stakeholder by facilitating regular interaction and implementing appropriate trackers. 3)Ensure continuous assistance to new team members to support efficient and quick onboarding and knowledge sharing sessions across Sanofi Global Hub. Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data. 2) Lead/contribute to the global coordination efforts to identify, develop, innovate/automate and implement departmental standards, applications, processes and trainings; participate to the evaluation of tools/applications and endorse their development. 3) Collaborate effectively with Principal biostatisticians and programmers to ensure high quality and timely statistical programming deliverables across the TAs. 4) Design, develop, test, implement, and document statistical programming in high-level software packages e.g., SAS. 5) Produce well documented data packages that include tables, listings, and figures. 6) Work closely with the Head Biostatistics and Statistical Programming, Principal Biostatisticians to develop and implement project management tools / tracker to automate the proper resource assignment & utilization, QC plans and timelines. 7) Develop and maintain statistical programming team using R / Python. Customer: Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables. About you Experience : Master's degree minimum 8 years/B.Sc. minimum 10 years of relevant experience required Soft skills: Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines Technical skills : Advance SAS programming skills, SDTM & ADaM (CDISC) and clinical data environment across multiple therapeutic areas Education : Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field. Languages : Excellent English language knowledge – written and spoken Pursue Progress, discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Experience 9+ Years Education • Master's degree in Statistics or equivalent • Ph.D. in Statistics or equivalent & ≥ 6 years of industry related experience Skills to have • Ability to work successfully within a global cross-functional teams leading to successful regulatory filings and approvals • Excellent verbal and written communications skills. • Ability to be flexible and adapt quickly to the changing needs of the organization. • Ability to organize multiple work assignments and establish priorities. • Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement. Sr. PS Specifics • Extensive knowledge of statistical / clinical trials methodology as it relates to clinical development • Demonstrated data analysis planning, execution and delivery experience in multiple clinical development setting, e.g. different diseases, indications, development phase • Past submission and regulatory interaction experience The Biostatistician is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, biostatisticians can have responsibilities for integrated summaries and/or supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the GBDS (Global Biometric Sciences) Biostatistics Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team. Biostatisticians are individual contributors and report to a GBDS Lead. The Biostatistician is responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level. These contributions lead to better understanding of the asset being studied, improved development decisions, and an increased likelihood of regulatory and market success. This role has significant stakeholder management responsibility with business partners on their team. The biostatistician III has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data. This person may interact with external vendors, key opinion leaders and regulatory agencies. • Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate • Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product • Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access. • Translates scientific questions into statistical terms and statistical concepts into layman terms • Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information • Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis • Communicates effectively with clinical and regulatory partners and external opinion leaders • 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 • Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted • Compliant with BMS processes and SOPs, global and project standards, and responsible for quality of deliverables • Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information • Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles • Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team. • Drives alignment at study team level, and escalates lack of team alignment to the GBDS Lead for resolution • Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions • Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project. • Keeps up to date with state-of-the art applied statistical methodology • Understanding of CDISC standards and implementation guides • Independently leads the development and execution of statistical aspects for multiple or complex studies • Leads portions of filing activities (e.g., multiple protocols, single indications) including planning for and execution of integrated analyses. • Defends protocols and SAPs at PRC reviews and provides independent reviews.

Type : full-time. Location : Remote from anywhere in the India. Description The Principal, AI Data Scientist will be responsible for supporting the implementation of innovative, complex and transformative AI/ML/GenAI solutions across the areas of Clinical Trial Execution and Digital Healthcare across Research and Development. Essential Functions Support the development and implementation of AI/ML/GenAI solutions to optimize clinical trial operations, including such areas as patient recruitment, patient retention, real-time data monitoring and automated data collection system build. Support the development and implementation GenAI applications for automated clinical trial documentation generation including such areas medical reports, clinical study reports, protocols and patient narratives. Support the development and implementation of Digital Healthcare applications for medical and scientific tools, RWE new ways of generating real data, patients engagement. Support the design and develop predictive models and generative AI solutions using diverse healthcare data sources, including clinical trials data, electronic health records, wearable devices, patient-reported outcomes, HEOR data, phase IV studies. Ensuring compliance with regulatory requirements and data privacy standards. Required Knowledge, Skills And Abilities Strong programming skills in Python, R, or similar languages, with experience in modern ML frameworks (PyTorch, TensorFlow). Demonstrated experience with generative AI technologies, including LLM architectures and frameworks. Knowledge/experience with digital healthcare tools design and development. Experience with natural language processing and generative AI for medical text analysis, generation, and interpretation. Demonstrated ability to build relationships with stakeholders and subject matter experts. Familiarity with high compute cloud-based platforms and services, in particular AWS. Familiarity with code version control and MLOps deployment approaches. Minimum Requirements Advanced degree (MS or PhD) in Data Science, Computer Science, Biostatistics, or related field. 3 - 5 years of related professional experience, with 1+ years of experience applying AI/ML techniques to healthcare or clinical research data. Experience in healthcare/AI implementation in healthcare field is a plus. Knowledge of digital healthcare tools design and development. (ref:hirist.tech)

Senior Project Assistant for the Department of Medical Gastroenterology (Job Code-1607) Qualification: Graduate. B.Sc. Biostatistics / Statistics. External Salary: Rs. 30,600/- (Consolidated). Mode of Appointment: Project Accommodation: Not Provided. Experience: At least 2 years after completing the qualifying exam, preference would be given to those who have previously worked in clinical research projects. Collecting internal / external data from various site. Randomization of Patients Consolidating numerical data into databases Using Statistical Software to perform an analysis of the numbers Applying various calculations and formulas to analyze and interpret the data Ensuring the data and calculations are accurate Presenting the data and Statistical findings to the Research Team. Patient recruitment in Clinical Trial, maintain patient data, Co Ordination with the clinical team, maintenance of inventory and accounts. Co Ordination between study centers.

Job Description 1. Collate and present literature review on preformulation, physico-chemical characterization, stability, bioavailability / pharmacokinetics of molecules to aid complex generic product development. Application of fundamental understanding of Pharmaceutical Sciences, Biopharmaceutics, Pharmacokinetics & Biostatistics in generic formulation design. 2. Lead the effort towards reconstruction/ reverse engineering of innovator formulation including preformulation studies, evaluation of API & in-house formulation using modern analytical, imaging and characterization techniques. 3. Responsible for brain storming with team and clarification of ideas aimed at development of discriminatory and bio-relevant dissolution methodologies, review and validation of data generated from this effort with the objective of providing the formulation team tools that aid in systematic deduction of formulation variables and improving the BE hit rates. 4. Supervise & perform preformulation studies for complex generic formulations and develop innovative methods to perform RLD characterization studies to aid development of formulation/manufacturing strategies for complex generic products. 5. Lead the team in developing prospective in vitro/in vivo model for new projects- Connecting RLD design and reported in vivo (PK) results to build targeted dissolution profile & dissolution methodologies before initiation of actual development. 6. Perform retrospective/ prospective biopharmaceutical modeling of in vitro/in vivo data of complex generics with an objective of establishing IVIVR/C. Dissection and meta-analysis of pilot/ pivotal BE data- Using systematic deduction & statistical approaches. 7. Document methods and results from dissolution studies, biopharmaceutical modeling, preformulation studies and RLD characterization experiments. And to prepare reports/presentations for project discussions with the formulation development group Work Experience PhD with 3-5 years experience/ Fresh PhD/ Post Doc in Pharmcokinetics (PK) and Biopharmaceutics to consider as M1 Education Masters Doctorate in Pharmaceutical Technology Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility

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 . Position: Senior Specialist, Biostatistics Location: Hyderabad At Bristol Myers Squibb, we are inspired by a single vision - transforming patients lives through science. In oncology, hematology, cell therapy, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Position Summary The Senior Specialist, 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 BMS 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 Fresh MS in statistics, or biostatistics or related scientific field preferred. (0-2 years of experience) 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 Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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. 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. 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. 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.

Work Schedule Other Environmental Conditions Office At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Summarized Purpose: We are excited to be expanding our Medical Writing FSP Team in India. We seeking a PMW dedicated to a client in the FSP space; preferred candidates will have experience in Structured Content Authoring systems and automation to support delivery. The ideal candidate will be experienced and highly skilled, responsible for creating, reviewing, and managing clinical regulatory documents. This role requires a strong understanding of scientific concepts, exceptional writing skills, and the ability to communicate complex information clearly and concisely. Key Responsibilities: Lead the development, writing, and editing of complex clinical and regulatory documents. Collaborate with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and medical affairs, to ensure the accurate and timely completion of documents. Ensure documents align with regulatory guidelines, company standards, and industry best practices. Provide strategic input and guidance on document content, structure, and presentation. Mentor and provide oversight to junior medical writers and ensure high-quality deliverables. Manage multiple writing projects simultaneously and prioritize tasks effectively. Stay current with industry trends, guidelines, and regulatory requirements. Education and Experience: Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred. Regulatory writing experience that provides the knowledge, skills, and abilities to perform the role (comparable to 8+ years in core Regulatory Medical Writer role capacity). Experience working in the pharmaceutical/CRO industry required. Experience in managing and directing complex medical writing projects required. Extensive experience in Phase 3 CSRs and/or protocol development required. EU CTR experience preferred. Experience working on structured content management system and AI-driven content creation, and familiarity with Natural Language Generation preferred. Knowledge, Skills, and Abilities: Excellent organizational and program management skills. Proven leadership skills to manage and mentor a team of medical writers. Extensive knowledge of regulatory guidelines and drug development processes. Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders. Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards. Self-motivated and adaptable. Excellent judgment; high degree of independence in decision making and problem solving. Capable of mentoring and leading junior level staff. What We Offer: At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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 . Position: Senior Specialist, Biostatistics Location: Hyderabad At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, cell therapy, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Position Summary The Senior Specialist, 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 BMS 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 Fresh MS in statistics, or biostatistics or related scientific field preferred. (0-2 years of experience) 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 Why You Should Apply Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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. 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.

🔹 Role-1: Statistical Programmer – SDTM (End-to-End) Location: Remote Experience: 4+ Years Job Description: We are hiring a Statistical Programmer with 4+ years of experience in end-to-end SDTM programming , including specification creation and SDRG preparation . Key Responsibilities: Develop and validate SDTM datasets in compliance with CDISC standards Interpret mapping specifications and raw data Prepare the Study Data Reviewer's Guide (SDRG) Collaborate with global clinical teams and statisticians Maintain documentation and ensure submission compliance Requirements: 4+ years of hands-on SDTM programming experience Proficient in SAS and CDISC implementation Strong knowledge of clinical trial data and regulatory standards Excellent attention to detail and communication skills ------------------------------------------------------------------------------------------------------------- 🔹 Role-2: Senior Statistical Programmer – SDTM, ADaM, TLF Location: Remote Employment Type: Full-Time Experience: 8+ Years Notice Period: Only Immediate or 1 Month notice period candidates will be considered Job Description: We are looking for a Senior Statistical Programmer with 8+ years of experience in SDTM, ADaM, and TLF programming for regulatory clinical trial submissions. Key Responsibilities: Design and develop SDTM and ADaM datasets per CDISC Program and validate Tables, Listings, and Figures (TLFs) Perform quality control and regulatory submission support Work closely with Biostatistics and Clinical Data teams Drive programming timelines and deliverables across studies Requirements: 8+ years of SAS programming in a clinical research environment Expert in SDTM, ADaM, and TLF generation Strong understanding of FDA/EMA submission standards Good communication, documentation, and collaboration skills

Role & responsibilities Primarily works at the Product/Program Level Provide input for budget planning Manage and Deliver assignments with quality and within timelines Possible to have direct reports; Possible to oversee contingent workers and/or vendors; likely to provide training to others; Analyzes needs to manage resources Responsible for statistical aspect of study designs and data analyses for clinical studies Provides study design input and consultation for clinical endpoint assessments and sample size planning Prepares, or oversees the preparation of statistical sections of clinical protocols in collaboration with key stakeholders, as deemed necessary Writes, or oversees the writing of, statistical analysis plans Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts, and other documents to support the marketing of Teva products Leads the conduct of analyses and document preparation to support global regulatory submissions, including briefing packages, integrated analyses, and regulatory responses. Collaborates with outsourcing partners and oversees conduct of statistical aspects of outsourced studies, as appropriate Proactively assesses and identifies processes that require improvement Participates in department initiatives to further the effectiveness of global statistics Implements innovative and cutting-edge clinical trial design, methodology and analysis Preferred candidate profile Ph.D./MS in Statistics/Biostatistics (or related field)

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 . Position Senior Specialist, Biostatistics Location Hyderabad At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, cell therapy, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Position Summary The Senior Specialist, 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 BMS 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 Fresh MS in statistics, or biostatistics or related scientific field preferred. (0-2 years of experience) 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 Why You Should Apply Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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. 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.

Job Posting Title: Senior Principal Biostatistician Reports to (Job Title) : - Group Head Biostatistics and Pharmacometrics Job Description : The Senior Principal Biostatistician is responsible and accountable for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. Works independently at the trial level and may lead indication or project level statistical activities for a development project under limited supervision. Proposes and leads implementation of modern and innovative trial/experimental designs, statistical models, analysis and data exploration methodologies at the study or project level. Study level : - 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. 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 leve l- 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. Education (desirable) : - MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 4+ years relevant work experience. Languages : - Fluent English (oral and written) Requirement : - Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives. Proven knowledge and expertise in statistics and its application to clinical trials. 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). Knowledge of drug development and Health Authority guidelines. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives. Experience in Franchise/Therapeutic Area and/or regulatory activities desirable.

Rama Super Speciality Hospital is looking for Professor Community Medicine to join our dynamic team and embark on a rewarding career journey Professor is a full-time academic position in a college or university, responsible for teaching, conducting research, and serving on committees They play a critical role in contributing to the intellectual life of their institution and in preparing the next generation of professionals and leaders Responsibilities:Teach a range of courses in the department, at both the undergraduate and graduate levelsConduct original research in the field and publish findings in academic journals and at conferencesAdvise students and mentor junior faculty membersParticipate in department and university-wide committees, such as curriculum committees and search committeesPursue external funding opportunities to support research and teaching activities Engage in professional development activities to stay current in the field and enhance teaching skillsRequirements:A record of successful teaching and research, with a strong publication record in academic journals Ability to teach a range of courses in the department, at both the undergraduate and graduate levelsStrong communication and interpersonal skills, with the ability to mentor students and junior faculty membersA commitment to continued professional development and growth

Post-doctoral Fellow in Epidemiology and Biostatistics, School of Public Health The University of Hong Kong Apply now Ref.: 532501 Work type: Full-time Department: School of Public Health (22400) Categories: Senior Research Staff & Post-doctoral Fellow Hong Kong Applications are invited for appointment as Post-doctoral Fellow in Epidemiology and Biostatistics, School of Public Health (Ref.: 532501), to commence as soon as possible for one or two years on temporary term basis, with the possibility of renewal subject to satisfactory performance and funding availability. Applicants should possess a Ph.D. degree in epidemiology, biostatistics, applied mathematics, data science or other related disciplines. They should have strong interests in research on infectious disease epidemiology. They should have excellent communication skills, experiences in knowledge sharing, a strong record of research output, and the ability to work independently as well as in a multidisciplinary team. Research experience in analysing infectious disease data using statistical and/or mathematical approaches would be highly desirable. Experience in statistical analysis, and proficiency in statistical and computer modelling software (e.g. R, Python, Matlab, and C++) would be advantageous. The appointee will work with a research team to study the methodologies for estimating population immunity against infectious diseases, to analyse large and complex datasets, and to perform other duties as assigned. Post-doctoral Fellows will work semi-independently under the supervision and mentorship of senior academic staff and will have opportunities to apply research funding, present and publish their own research findings to their peers. Information about the School can be obtained at http://sph.hku.hk/. A highly competitive salary commensurate with qualifications and experience will be offered, in addition to annual leave and medical benefits. The University only accepts online application for the above post. Applicants should apply online and upload an up-to-date CV. Review of applications will start on (2 weeks from posting) and continue until 31 August 2025 , or until the post is filled, whichever is earlier. Advertised: Jun 26, 2025 (HK Time) Applications close: Aug 31, 2025 (HK Time) Back to search results Apply now Whatsapp Facebook LinkedIn Email App

The University of Hong Kong Apply now Ref.: 532414 Work type: Fractional / Part-time, Full-time Department: School of Public Health (22400) Categories: Executive / Technical / Support Hong Kong Full-time/Part-time Nurse (holding a functional title of Research Nurse)/Enrolled Nurse (several posts) in the Division of Epidemiology and Biostatistics, School of Public Health (Ref.: 532414) (to commence as soon as possible for one year on temporary terms, with the possibility of renewal subject to satisfactory performance) Applicants should possess a Higher Diploma or above and be registered with the Nursing Council of Hong Kong, preferably with at least 3 years’ work experience in phlebotomy, research and community-based studies. They should have a good command of written and spoken English and Chinese (including fluent Cantonese). They should be organized, responsible, and able to work independently as well as in a team. The appointees will assist in a range of ongoing community field studies on infectious disease epidemiology and/or vaccine trials. They will perform vaccination, venipuncture, and respiratory sample collection in outreach centres, assist in participant recruitment and follow-up activities, and perform other duties as assigned. Irregular working hours will be required occasionally. Information about the School can be obtained at http://sph.hku.hk/. A highly competitive salary commensurate with qualifications and experience will be offered, in addition to annual leave and medical benefits, if applicable. The University only accepts online application for the above post. Applicants should apply online and upload an up-to-date C.V. Review of applications will commence as soon as possible and continue until August 31, 2025 , or until the posts are filled, whichever is earlier. Advertised: Jun 27, 2025 (HK Time) Applications close: Aug 31, 2025 (HK Time) Back to search results Apply now Whatsapp Facebook LinkedIn Email App

**** Candidate should be good in R (Development) Language **** 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.

Senior Programmer Join Cytel’s enthusiastic and collaborative Biometrics team by contributing to the overall success of one of our major pharma clients. Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward. We are experiencing exponential growth on a global scale and hiring Senior Statistical Programmers to join our FSP division. You will apply your know-how in CDISC standards (SDTM & ADaM) and advanced SAS programming skills, to support or lead one or more Phase I-IV clinical trials, across a variety of therapeutic areas. This role can be performed as fully remote. Our values We believe in applying scientific rigor to reveal the full promise inherent in data. We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. We prize innovation and seek intelligent solutions using leading-edge technology. How You Will Contribute Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming Generating and validating analysis datasets/analysis files, and complex tables, listings, and figures ( TLFs) Production and QC / validation programming Generating complex ad-hoc reports utilizing raw data and analysis datasets Applying strong understanding/experience of Safety and Efficacy analysis Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries Performing lead duties for assigned clinical study under principle programmers oversight Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. Being adaptable and flexible when priorities change Being able to create specifications for derived/analysis datasets Generating and validating Non-CDISC transformation datasets and analysis datasets Proficient knowledge with SDTM/ADaM and TLF’s. General expertise with Figures Individuals should be able to start programs from scratch and have the ability to handle complicated domains and outputs related to the protocol and SAP. Creating and reviewing submission documents and eCRTs They must demonstrate a good understanding of the endpoints and data collection, with the ability to read and write specifications related to the respective implementation guides. R & complex macro writing are a plus What You Offer Bachelor’s or master’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc. At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above. Familiarity with drug development life cycle and experience with the analysis and reporting of clinical trials’ data. Familiarity with ICH E3 (Structure and Content of CSR) and E9 (Stat Principles). Well conversant with regulatory requirements and drug development process. Study lead experience, preferably juggling multiple projects simultaneously. Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH Strong CDISC (both SDTM and and ADaM) experience is required. Solid ADaM and complex TFL skills. Strong QC / validation skills. Good ad-hoc reporting skills. Experience in pooling/ ISS/SE studies is an asset. Experience with cross-over studies is a plus. Submissions experience utilizing define.xml, creation of annotated CRF, data reviewer’s guides and other submission documents. Excellent analytical & troubleshooting skills. Being flexible to adapt and use client’s macro codes. R programming knowledge for data manipulation and graphs is an asset. Ability to provide quality output and deliverables, in adherence with challenging timelines. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners. Applied experience in one of the following therapeutic area is a plus: oncology, rare diseases, gastroenterology, respiratory, immunology, hepatitis and vaccines. Experience in medical affairs is a plus. Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law. Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.