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7 years

0 Lacs

Bengaluru, Karnataka

Work from Office

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. The Advanced Intelligence (AI) team brings the power of data and advanced analytic capabilities such as artificial intelligence, machine learning, visual analytics and predictive analytics to identify and solve high-value business questions. Responsibilities: Lead a diverse group of talented visual data scientists to apply their skillsets in diverse areas such as scientific publications, discovery and business development. Partner with business/research teams to identify, scope, and execute visual analytics efforts that answer business/scientific questions and deliver value to patients. Maintain a broad understanding of the pharmaceutical business and be fully engaged with business/research teams, bringing an objective voice to the table and facilitating decisions grounded in visual analytics and data science. Collaborate with other analytics team members to review and provide feedback on the analytics being done and be willing to seek feedback from other team members about your own work. Stay current with respect to data science and visual analytics methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected. Collaborate with others to design, develop and deploy enterprise-level analytics capabilities/solutions, including applications in explainable AI. Consult domain experts and elucidate workflows to incorporate advanced analytics in tools for users with no background in data science. Ability to influence people to adopt innovative data visualizations and methods. Communicate results effectively using data story telling techniques Basic Qualifications: PhD in Computer Science, Statistics, Biostatistics, Engineering) or a related field OR M.S. in one of the above fields plus with 2+ years of experience (excluding internships) in the industry OR B.S. in one of the above fields plus with 7+ years of experience (excluding internships) in the industry, including people management experience, Proficiency with deploying web-based data visualization using d3, HTML and CC. Additional Skills/Preferences: Combined degree with Journalism. Working knowledge of scripting languages like R and Python and / or dashboarding platforms like Power BI for quick prototyping. Understanding of advanced analytics in statistics and machine learning Advanced knowledge of visual analytics algorithms like force directed graph and network diagrams. Proficiency with grammar of graphics and data story telling Internal or external consulting experience Agility and flexibility to work with very diverse problems and business partners Ability to work with diverse data sources and data types Self-management skills with a focus on results for timely and accurate completion of competing deliverable Additional Information: When applying please attach or submit a link to your portfolio of work You will be on a hybrid work schedule in Bengaluru, India. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly

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7.0 years

0 Lacs

Bengaluru, Karnataka

Remote

Location Bengaluru, Karnataka, India Job ID R-227172 Date posted 19/05/2025 Job Title: Associate Director - Statistical Programming Work Location: Manyata Tech Park, Bangalore, India Work Schedule: Three days on-site, two days remote (3/2) Career Level: E – Individual Contributor position. Introduction to role The Associate Director of Statistical Programming will oversee statistical programming activities for multiple clinical studies, maintain programming infrastructure, and ensure compliance with SOPs to produce quality and timely deliverables. This role requires extensive experience and proven skills in the use of SAS within a Statistical Programming environment, along with a complete understanding of statistical programming processes, procedures, and roles. The successful candidate will support Biostatistics in statistical analysis, including generating analysis data listings, tables, and figures, and creating all files necessary to support an electronic submission in the eCTD format. Additionally, strong people management and supervisory skills are essential to provide direct line management to statistical programmers, identify training needs, and optimize staff utilization. The role also involves managing the day-to-day activities of external partners in delivering program deliverables. Accountabilities Serve as the Lead Programmer and Manager of the statistical programming efforts. Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs. Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using Alexion specifications. Ensure that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit. Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team. Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary. Create and/or review programming plans, and ensure appropriate resource allocation and prioritization. Act as the primary department contact to ensure that department standards are implemented in all studies. Manage adherence to all company policies, SOPs, and other controlled documents; ensure all programming activities adhere to departmental standards. Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support. Essential Skills/Experience 7+ years statistical programming experience in the CRO or Pharmaceutical Industry. 4+ years project management experience in the CRO or Pharmaceutical Industry. Experience with CDISC SDTM and ADaM models and transforming raw data into those standards. Strong people management skills and supervisory skills gained from direct line management or supervisory experience. Proven abilities to lead and manage cross-functional projects, and people, from concept to completion. - Strong verbal and written communication skills - ability to clearly and effectively present information. An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance. Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures. Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs. Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle. Advanced experience with: Constructing technical programming specifications. Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Creating all files necessary to support an electronic submission in the eCTD format. Desirable Skills/Experience BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area. Competencies: Accountability Collaboration Decision Quality Drive for Results Perseverance Problem Solving Informing Peer Relationships Time Management Building Effective Teams Managing Through Systems At AstraZeneca's Alexion division, we are driven by our passion for making a difference in the lives of patients with rare diseases. Our unique approach combines the agility of a biotech with the resources of a global biopharma leader. We foster an inclusive culture where innovation thrives, empowering our employees to grow both personally and professionally. Join us to be part of a team that is dedicated to transforming lives through groundbreaking science and compassionate care. Ready to make an impact? Apply now! Date Posted 20-May-2025 Closing Date 30-Jul-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify. ]]>

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0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

Job Requirements Role Summary: ConcertAI is a fast-growing healthcare research organization, leading the market in oncology healthcare data analytics. Our dynamic, fun, and highly experienced team is looking for a Statistical Analyst to join us. As a Statistical Analyst in the Real-World Evidence (RWE) business unit, you will be responsible for statistical analyses conducted using ConcertAI’s industry-leading and cutting-edge healthcare data resources. Our team operates in a cross-functional environment with representatives from other functions such as our Epidemiology/HEOR, Data Curation, Data Products, and Data Science teams As a Statistical Analyst on our team, you will be reporting to a Manager on the Biostatistics team and will provide high quality analyses and summaries for studies supporting regulatory submissions and health economics and outcomes research (HEOR) studies. Your responsibilities will involve preparing, linking, and manipulating data as well as performing statistical analyses for research projects dedicated to improving our understanding of the patient journey and treatment outcomes in the oncology space, as well as making meaningful impacts on patients' lives. Statistical Analysts will also participate in data quality control and review results. The Statistical Analyst will contribute to, and support, corporate goals to progress the company’s portfolio of products. Responsibilities Collaborates with Project Managers, Principal Investigators, and other scientific staff to design appropriate study analyses based on project scope and client objectives. Reviews and revises study protocols for accuracy, consistency, thoroughness, and quality of statistical methods and presentation. Drafts and reviews Statistical Analysis Plans (SAPs) to define study cohort eligibility criteria, study measures, and statistical methodologies. Creates data structures by determining patient or disease cohorts, establishing study samples, and structuring data files according to research objectives and study design. Prepares analysis-ready data by loading, extracting, and transforming data across several databases, as well as searching in schemas, cleaning outbound files, and merging data tables. Executes quality control checks of data for anomalies, frequency, and distribution of data points for accuracy and consistency; determines root causes of errors, recommends solutions, and resolves data issues through queries and programming scripts. Performs statistical analyses in accordance with SAPs and generates analytic reports, tables, graphics, and slides. Contributes to methodology and results sections of study deliverables such as protocols, summary reports, abstracts, and manuscripts to ensure accuracy of the programming and statistical descriptions. Interfaces with Scientific Management and Data Curation team to clarify data requests, extract data sets, and review case report forms, as well as the Data Operations team to assemble and clean data sets. Joins client meetings and contributes to the discussion of findings as the statistical lead on assigned projects. Manages task timelines and communicates status updates with project team members regarding project requirements, deadlines, and priorities. Follows company policy and procedures regarding quality control, data security, and the ethical conduct of research involving human subjects, as well as the provisions of the HIPAA security and privacy rules. Participates in other projects as assigned including statistical support roles and contributing to internal initiatives. Work Experience Requirements Master’s degree and up to two years of related programming and statistical experience, or Bachelor’s degree and up to five years of related programming and statistical experience with an area of study in quantitative science such as Statistics, Biostatistics, Analytics, Biometrics, Operations Research, Engineering, or Data Science. Background in scientific research study design and methodology, data analysis, and statistical programming using patient-level datasets. Expertise in SQL is required Expertise with R is required Experience using healthcare data, such as claims or electronic medical records, or patient-reported outcomes is required Experience with GitHub is preferred Experience applying statistical methodologies and advanced mathematical concepts such as ANOVA, linear regression, mixed models, time-to-event analyses, correlation analysis, sampling theory, analysis of categorical data, and appropriate transformations and permutations. Experience integrating and processing complex data (e.g., extracting, transforming, loading, scrubbing). Ability to proactively collaborate on multiple projects and deadlines, establish priorities for work activity, and solve practical problems. Exceptional verbal and written communication skills with a proven ability to clearly and convincingly present information to a wide range of internal and external audiences. Aptitude for understanding and applying best practices from documents such as safety rules, operating and maintenance instructions, procedure manuals, and correspondence. Familiarity with basic productivity software (e.g., Microsoft Excel, Microsoft Word, Web Conferencing Applications). Detail-oriented, highly motivated, results-driven, and flexible to work in a scaling environment. Particular consideration will be given to applicants with the following qualifications Research history within the oncology space related to one or more specific solid tumor types, or to hematological malignancies. Working knowledge of external control arms or other use cases of real-world evidence to support regulatory decision-making. Understanding of FDA regulatory requirements, ICH guidelines, and GCP. Publication track record preferred. Show more Show less

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0 years

0 Lacs

India

Remote

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Biostatistician II to join our A-team (hybrid*). The Sr. Biostatistician II (Sr2Bios) supports the statistical analysis and clinical data activities of the Allucent Biostatistics/Statistical Programming team. This position leads projects, writes statistical documents and statistical sections of study documents for simple to moderately complex studies, and provides senior review of statistical documents and outputs. This position may assist in the programming of datasets and outputs using SAS®. The Sr2Bios will regularly interact with other members of the Allucent biostatistics project team and will interact with clients when leading a study. In this role your key tasks will include: Knowledge in clinical research with emphasis in the development and support of the analysis of clinical trial data Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for simple to moderately complex studies Familiarity with complex statistical methods and concepts Provide senior reviews of statistical documents, data, and outputs for simple to moderately complex studies to ensure quality and integrity Execute a statistical analysis of any complexity as specified in a protocol or analysis plan Interpret and communicate results for complex statistical analyses and outputs Develop and/or review the statistical sections of a study protocol for simple to moderately complex studies Review statistical sections of a clinical study report to ensure accurate descriptions of statistical methods used and results of analyses Provide randomization materials including randomization schedules and treatment kit lists per Allucent SOPs and the sponsor-approved specifications Develop or review documents for integrated analyses (e.g. ISS/ISE), including integrated SAPs and statistical sections of integrated study reports Support responses to regulatory questions on statistical issues relating to client regulatory submissions Working knowledge of SAS® for production and validation of datasets and statistical outputs Write and review specifications for complex ADaM or analysis datasets Annotate or review annotations of TLF mocks to assist programming efforts. Working knowledge of CDISC standards Review CRF design to ensure it conforms with the study protocol and analysis needs. Knowledge in clinical research with emphasis in the development and support of the analysis of clinical trial dat Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for simple to moderately complex studies. Familiarity with complex statistical methods and concepts Provide senior reviews of statistical documents, data, and outputs for simple to moderately complex studies to ensure quality and integrity Execute a statistical analysis of any complexity as specified in a protocol or analysis plan Interpret and communicate results for complex statistical analyses and outputs Develop and/or review the statistical sections of a study protocol for simple to moderately complex studies Review data management documents as requested to ensure the integrity of study data Lead simple to moderately complex projects by fulfilling the following responsibilities: communicate with the client and statistical team, set and achieve timelines and milestones, ensure proper execution of the study SAP, monitor programming efforts in collaboration with the lead programmer, and work with management to ensure adequate resourcing Lead management of project budgets, the identification of out-of-scope work, and the change order process Function as the lead unblinded statistician for studies and manage unblinded tasks including implementation of interim analyses and participation in DMC/safety review meetings Accountable for leading biostatistics and programming activities for a program of studies of high complexity and/or of high value. Actively support staff learning & development within the company Identify, recommend, and execute departmental initiatives, tools, and process solutions to enhance efficiency and quality. Review and evaluate biostatistics and statistical programming processes and procedures within the Quality Management System Represent Allucent at proposal bid defences and/or marketing meetings with prospective clients Establish positive relationships with current and future clients. Requirements To be successful you will possess: Bachelor's degree; master's degree preferred, in a relevant discipline including, but not limited to, statistics, mathematics, life science, epidemiology, or healthcare . Minimum 5 years of relevant work experience. Good knowledge of GxP. Familiarity with relevant regulations and guidelines. GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements. Working knowledge of computer systems, applications and operating systems. Demonstrate critical thinking and analytic skills Strong written and verbal communication skills including good command of the English language. Ability to work in a fast-paced challenging environment of a growing company. Strong individual initiative. Excellent attention to detail and commitment to quality. Proficiency with various computer applications such as Word, Excel, and PowerPoint. Ability to establish and maintain effective working relationships with co-workers, managers, clients, and vendors. Knowledge of SAS. Collaborative and client-focused. Ability to effectively manage multiple tasks and projects. Strong leadership skills. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/office-based* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices . "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." Show more Show less

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8 - 12 years

11 - 16 Lacs

Bengaluru

Work from Office

Professional with 8 to 12 years of experience in biostatistics & R Programming would be preferred

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5 - 8 years

5 - 9 Lacs

Pune, Mumbai (All Areas)

Work from Office

Hi , We are hiring for Leading ITES Company for R Biostatistical Programmer Profile. Job Description: Minimum 5 to 8 years experience in Statistical Programming in clinical domain Experience and understanding of ICH GCP principles and clinical drug development process Good knowledge of CDISC SDTM and Adam standards Good knowledge and hands on experience in Base SAS, SAS / STAT, SAS /Graph modules and R Statistical programming Preferred Educational Qualification for the role: Bachelors or Masters degree or equivalent in statistics, mathematics, life science, engineering or computer related subject Essential Experience for the Role : Good knowledge and hands on experience in R Statistical Programming in Clinical Domain To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 291 a) For Position in Pune Search : Job Code # 292

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0 - 1 years

0 - 1 Lacs

Goregaon, Mumbai, Maharashtra

Work from Office

Job Summary: The Medical Writer will be responsible for developing high-quality scientific documents that effectively communicate complex medical information. This includes writing, reviewing, and editing clinical trial protocols, regulatory submissions, medical journal articles, white papers, and educational materials for both medical professionals and the public. The ideal candidate should possess strong writing skills, knowledge of medical terminology, and the ability to simplify and present clinical data clearly and concisely. Key Responsibilities: Content Development: Create, write, and edit clinical study reports, patient narratives, manuscripts, regulatory documents (such as Clinical Study Protocols, Investigator’s Brochures, and Clinical Study Reports), and other scientific documents. Regulatory Submissions: Assist in the preparation of documents for regulatory submissions to agencies such as the FDA, EMA, and other health authorities, ensuring compliance with regulatory guidelines and timelines. Data Interpretation: Analyze, interpret, and present complex scientific and clinical data in a clear, accurate, and concise manner for various audiences.Work closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to obtain relevant data and insights needed for writing.Conduct literature reviews and stay up-to-date on medical and scientific developments in the relevant therapeutic areas.Ensure all written materials meet industry standards and are compliant with regulatory requirements and company guidelines (e.g., Good Clinical Practice, Good Publication Practice, ICH guidelines).Review and edit documents for accuracy, consistency, grammar, and style, adhering to internal standards and external submission requirements. Requirements: Collaborative Writing: Literature Review: Compliance: Editing and Quality Control: Education: Bachelor’s degree in life sciences, pharmacy, medicine, or related field (Master’s or PhD preferred). Experience: 2-5 years of experience in medical writing within the pharmaceutical, biotechnology, or medical device industry. Skills: Strong understanding of medical/scientific terminology and statistical concepts. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with relevant medical writing software. Ability to work with tight deadlines and manage multiple projects simultaneously. Excellent communication skills and attention to detail. Familiarity with regulatory submission processes and industry standards (FDA, EMA guidelines, ICH GCP). Certifications (Optional): Certification from AMWA (American Medical Writers Association) or EMWA (European Medical Writers Association) is a plus. Preferred Qualifications: Experience writing in specific therapeutic areas (e.g., oncology, neurology, cardiology, etc.). Prior experience working with CROs or in a medical communications agency. Familiarity with publication processes and best practices for manuscript preparation Please share your resume and work at charmi@pinkskyhr.com Job Types: Full-time, Permanent Pay: ₹25,000.00 - ₹100,000.00 per month Schedule: Night shift Rotational shift UK shift US shift Experience: total work: 1 year (Preferred) Work Location: In person

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5 years

0 Lacs

Thane, Maharashtra

Work from Office

Job Overview Prepare analysis plans and write detailed specifications for analysis files, tables, listings and figures. Interpret analyses and write statistical sections of study reports. Provide training, guidance and mentorship to lower level and new staff. Essential Functions Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution. Leadership: Perform statistical team lead role on single studies. Through this, works closely with the Project Team Lead and supervisor to deliver on time, with high quality and within budget. Build and maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities. Demonstrates and promotes efficient communication. If in lead role, runs meetings, documenting where necessary and following up on actions. Actively participates in internal project team meetings, provides timely progress updates. As a lead, will have input on estimate at completion (EAC) reporting. Data Management: Assist in reviewing or advising data management staff on database design, validation checks and critical data. Handles data issue resolutions. If in lead biostatistical role, handles lock and unblinding process with appropriate supervision. Statistical Analysis Plan (SAP) and Shells: Authors or performs quality control review (QC) of SAPs and shells. Make best use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). May author or QC complex SAPs, under supervision if needed. Datasets: Writes and maintains programming specifications. Programs assigned datasets to industry standards. Handles dataset derivations and assignment. Tables, Listings and Figures (TLFs): Writes programming specifications for statistical analyses outputs. Programs TLFs, maximizes programming efficiency with use of tools, where applicable. Checks resulting output for format and content, and questions specification as needed. Ensures consistency across items produced. Timelines: Plans and documents timelines, forecasts resource needs, suggests work may be out of scope. Financials: Shares accountability (with resource managers) for the financial success of assigned studies. Accountable for controlling costs and maximizing revenue recognition. Responsible for sharing budget expectations with the team. Raises concerns to manager if new work or rework appears to be out of scope. Understands 'scope of work' and has an awareness of contract and budget assumptions. Knowledge Sharing: Helps train staff regarding operational items. Mentors junior staff. Supports colleagues and provides motivation as needed. Risk Management: Identifies risks to project delivery and/or quality and spends time to proactively avoid as well as proposes solutions to mitigate risks. Where possible, anticipate risks to minimize need for study level escalations. Other Clinical Data Interchange Standards Consortium (CDISC) requirements: Leadership: Under supervision within Compound. May perform statistical team lead role on studies within a compound. In addition to the leadership responsibilities above, also prioritizes and takes proactive approach to gain efficiencies in work across protocols. Study Start up: Assist with protocol development, sample size calculation, protocol and case report form (CRF) review. Protocol: Authors or performs quality control (QC) review of the statistical section of a protocol (making best possible use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). Proposals: May be able to review and comment on proposals/budgets at a study level. May contribute to request for proposals (RFP). May be expected to present at bid defenses. Clinical Study Report (CSR): Reviews or drafts CSR or statistical report. Customer: On occasion, may serve as primary point of contact for customer. May also consult on operational topics with clients. Lock and Unblinding Process: Handles the database lock and unblinding process. May participate on the biostatistics randomization team (drafts randomization specifications and/or reduce or perform quality control (QC) review of randomization schedules). May serve as unblinded lead statistician. Other Responsibilities: As defined on ad-hoc basis by managers. May assist with cross functional collaboration. Qualifications Bachelor's Degree Biostatistics or related field and 5+ years relevant experience Req Or Master's Degree Biostatistics or related field and 5+ years relevant experience Req Or Ph.D. Biostatistics or related field Req Typically requires 5+ years of prior relevant experience, or equivalent combination of education, training and experience. Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience. Excellent written and oral communication skills including grammatical/technical writing skills. Excellent attention and accuracy with details. In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials. Strong individual initiative. Strong organizing skills. Strong working knowledge of SAS computing package. Familiarity with other relevant statistical computing packages such as StatXact. Strong commitment to quality. Ability to effectively manage multiple tasks and projects. Ability to provide and accept direction of lead team members. Ability to solve moderately complex problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium (CDISC)/ADaM). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

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0 - 1 years

0 Lacs

Hyderabad, Telangana

Work from Office

Brief on the Organization: The Indian Institute of Public Health (IIPH) Hyderabad commenced its activities on July 1, 2008, with a mission to deliver public health education, pursue research and advocacy and support policy development. It lays strong emphasis on pursuing public health policy, practice, training and research, positioning its programmes according to the public health priorities of the state and the nation. The institute has brought together a highly qualified and diverse faculty of nationally and internationally trained and extremely motivated public health academics and practitioners. It aims to create an environment that supports excellence in instruction, research and practice. IIPH Hyderabad goals include training public health professionals through long- and short-term courses each year. The flagship courses of IIPH Hyderabad are the Post Graduate Diploma in Public Health Management. Short-term courses include training in research methods, statistics, disease surveillance, and change management. In addition, the institute collaborates with various academic, research, and administrative organizations to conduct workshops and conferences, and to undertake public health research and evaluation. The Indian Institute of Public Health Hyderabad (IIPH-H) as an arm of the Public Health Foundation of India (PHFI) aims to strengthen Public Health in India. The governance of IIPH Hyderabad is managed by a locally empowered society called the Institute of Public Health Sciences Hyderabad (IPHSH) Project Brief To facilitate the process of transparent and evidence informed decision making in the field of health, Government of India has created an institutional arrangement called the Health Technology Assessment in India (HTAIn) under the Department of Health Research (DHR). HTAIn is entrusted with the responsibility to collate and where needed generate evidence related to the clinical effectiveness, cost-effectiveness, and safety of medicines, devices and health programs using the Health Technology Assessment (HTA) approach. Indian Institute of Public Health, Hyderabad has been selected as a hub of HTAIn with the mandate of carrying out HTA for government and various other relevant agencies in that region. Qualification: Essential: PhD/Masters in Economics /Development Economics/Public Health with specialization in Health Economics, Health Financing and Health Policy. Desirable: Publication in reputed peer-reviewed journals will be given weightage Experience: Essential: Working post-degree in Health Economics research projects at middle to senior researcher level for 2-3 years. For PhD in Economics the post-PhD experience can be relaxed to 1 years provided the thesis was aligned to any public health project or programme and there are publication(s) from it Academic review (scoping and systematic) Competence at biostatistics/econometrics with fluent use of statistical software (preferably R and STATA) with working knowledge of large datasets.: Process to Apply: Interested and eligible candidates may send their updated CV to vacancies@iiphh.org Please mention the exact Position Code (IIPHH-HE-001-2025) in the email subject line and fill the application form: https://docs.google.com/forms/d/e/1FAIpQLSdrFEq26oT1zUHA2IjNNyIoCroCAbp4Ezf6W-pz2PLHU1ILnA/viewform?usp=header Only shortlisted candidates will be contacted for the interview. Please note that Annual Salary (CTC) will commensurate with available skills and fitment of the incumbent as per the selection process. Last Date of Receipt of Applications: 22 May 2025 Code: IIPHH-HE-001-2025 Location: IIPH Hyderabad Category: Fixed Term Salaried Duration of Position: 1 year or co-terminus with the project, as applicable Number of Positions: 1 Last Date: May 22, 2025

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0 years

0 Lacs

Sahibzada Ajit Singh Nagar, Punjab, India

On-site

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

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5 - 8 years

0 Lacs

Hyderabad, Telangana, India

Hybrid

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 . Summary The Real-World Data (RWD) Analyst will play a critical role within BIA Hyderabad. This specialized position focuses on analyzing and deriving insights from real-world data sources to generate evidence and support decision-making across the organization. The RWD Analyst will leverage a variety of RWD and evidence analytics techniques to contribute to research, clinical development, market access, and post-marketing activities. Roles & Responsibilities - Collaborate with cross-functional teams, including researchers, clinicians, market access and regulatory stakeholders, to understand data needs and objectives for RWD analysis Identify relevant real-world data from various sources, such as electronic health records (EHRs), claims databases, registries and other healthcare databases Clean, transform and preprocess real-world data to ensure data quality, consistency and compatibility for analysis Apply appropriate statistical techniques to analyze real-world data and generate insights on research questions or business objectives Partner with senior analysts to conduct observational studies, comparative effectiveness research (CER), patient outcomes research and other types of RWD analysis to evaluate treatment outcomes, safety profiles and healthcare utilization patterns Partner with senior analysts to develop and implement data analysis plans, including study designs, statistical methodologies and modelling approaches Interpret and communicate findings from RWD analysis through reports, presentations and visualizations to stakeholders Partner with senior analysts to collaborate with internal and external teams to design RWD studies, including protocol development, data collection and analysis Stay updated and compliant with the regulatory landscape related to real-world data analysis Contribute to the development and implementation of RWD strategies and best practices within the organization Skills and competencies Strong understanding of real-world data sources, such as electronic health records, claims databases, registries and other healthcare databases Proficiency in data pre-processing, cleaning and transformation techniques to ensure data quality and compatibility for analysis Knowledge of relevant statistical methodologies, including propensity score matching, survival analysis and regression models, for real-world data analysis Solid problem-solving skills and the ability to derive meaningful insights from complex real-world data sets Solid communication and presentation skills to effectively convey complex concepts and findings Ability to work collaboratively in cross-functional teams and manage multiple projects simultaneously Strong attention to detail and accuracy in data analysis and interpretation Experience - A Bachelor's or Master's degree (preferred) in a relevant field, such as Biostatistics, Epidemiology, Health Informatics or a related discipline Minimum 2-3 years experiencedemonstrated in real-world data analysis, preferably within the biopharma or healthcare industry Experience applying statistical and analytical techniques, such as observational study design, CER, patient outcomes research, and data modelling, to analyze real-world data Proficiency in R or SAS and SQL required Working knowledge of data visualizationtools, such as Tableau or Power BI, is desirable Working knowledge and familiarity with relevant statistical methodologies and study designs used in real-world data analysis Experience or familiarity with the biopharma industry or healthcare domains is preferred 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.

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0 - 3 years

0 Lacs

Maharashtra

Remote

Job description: Cactus Life Sciences is a remote-first organization, and we embrace an "accelerate from anywhere culture". You may be required to travel to our Mumbai office based on business requirements or for company/team events. If you are looking for challenging and rewarding work which combines your understanding of medical science and aptitude for writing into one unique job, the Medical Writer role is for you. This is an opportunity to grow your career and make a greater impact on the lives around you. Job responsibilities: Use scientific expertise to develop (write, proofread, and data-check) high-quality, client-ready scientific, medical, and educational materials like slides, abstracts, posters, manuscripts, MSL/training slide decks, infographics, congress and meetings materials, literature searches and reviews, standard response letters/medical information letters, and HCP engagement content according to client needs with excellent attention to detail under the guidance of the scientific leads. Liaise and build trusting and professional relationships with international pharmaceutical clients, healthcare professionals, internal and external stakeholders, including authors, reviewers, and key opinion leaders across therapeutic areas - learning to anticipate their needs. Effectively and proactively communicate with team members, authors/faculty, clients, and vendors. Attend workshops/seminars/trainings to hone your skills and contribute to organizational objectives. Attend client and other external meetings and support senior team members as needed. Apply your scientific and creative knowledge and work closely with client directors in developing ideas and executing effective medical communications initiatives in the digital space, including publication extenders, creation of infographics, interactive assets, website content, patient narratives, and medical information engagement plans. Ensure all materials follow/comply with client requirements/SOPs, style guides, client templates, client preferences (as applicable), and CACTUS’ internal SOPs. Any updates to either of these items should be made consistently and documents should remain up to date. Perform as a document specialist, provide intellectual input across document types, and contribute to making cutting-edge research accessible to specific audiences as appropriate, by maintaining current awareness of developments across therapeutic areas or disciplines. Share best practices and client preferences, thereby contributing to skill development within the medical communications team. #LI-Remote Qualifications and prerequisites: 1-3 years of experience in relevant fields of scientific writing. PhD/MD (Pharmacology) OR PhD (Life Sciences) OR PharmD with a good understanding of clinical research and medical communication. Should have experience working on publications. Experience working on gastric cancer publications would be preferable. Clear, concise, scientific style of writing, with a high level of attention to detail and excellent language skills. Excellent communication skills, especially with the clients. Ability to adapt writing style to different materials and target audiences. Basic knowledge of biostatistics. Literature reviewing and evaluation capabilities. Very good working knowledge of MS Office. Application process: Before applying, please ensure you meet the role requirements listed above and have legal authorization to work in the country where this role is advertised. Our selection process typically involves an initial screening by a recruiter, a technical assessment, and two to three interview rounds. For this role, the process will include two Technical Interviews with the Hiring Managers, and a Technical Assessment, where candidates will have agreed upon timeline to complete the task. The final round will be the HR Interview. All interactions will be conducted virtually via MS Teams. Equal Opportunity Our hiring practices reflect our commitment to providing equal opportunities and creating an environment where everyone can thrive, develop, and succeed. We celebrate the uniqueness of our team members and prohibit discrimination of any kind, based on race, color, religion, gender identity, sexual orientation, age, marital status, disability, or any other protected characteristic. Accelerating from Anywhere As a remote-first organization, these are essential attributes we look for in all our candidates. Taking ownership of your work with minimal supervision, showing strong ability to organize, prioritize and deliver results independently. Documenting work that brings everyone on the same page. Maturity to choose between synchronous and asynchronous collaboration. Effectively collaborating with colleagues across different time zones by setting dedicated hours for collaboration and keeping team members updated through your MS Teams status. About Us: At Cactus Life Sciences (cactuslifesciences.com), we believe the future of medical communications lies at the intersection of science, technology, and human connection. Headquartered in Princeton, New Jersey, with teams in Switzerland, the United Kingdom, India, and Japan, we help biopharmaceutical organizations redefine scientific exchange—leveraging AI, automation, and innovation while keeping patients at the heart of everything we do. Our expertise spans medical strategy, scientific content development, and medical education across therapeutic areas and the product lifecycle. By blending scientific rigor, agile operational models, and future-ready technologies, we partner with medical affairs teams to catalyze their transformation, adapt to a changing landscape, and drive meaningful outcomes for healthcare communities worldwide.

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5 - 8 years

0 Lacs

Indore, Madhya Pradesh, India

On-site

Job Description A minimum of 10 years of total experience in role of biostatistician on clinical studies with M.Sc. or a higher degree (Statistics/Biostatistics/Mathematical Statistics/ Applied Statistics) Independently interact with client and handle/address any queries from client Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations. Good knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and other regulatory guidance documents Good knowledge of statistical programming languages (including SAS) and R will be added advantage Adherence to SOPs and GPP Ensure teams compliance to organizational policies and procedures Quality and adherence to timelines. Skills Required RoleExpert Biostatistician Industry TypeITES/BPO/KPO Functional AreaPharmaceutical Required EducationAny Graduates Employment TypeFull Time, Permanent Key Skills BIOSTATISTICIAN CLINICAL TRAILS Other Information Job CodeGO/JC/21471/2025 Recruiter NameSangeetha

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5 - 8 years

0 Lacs

Pune, Maharashtra, India

On-site

Job Description A minimum of 10 years of total experience in role of biostatistician on clinical studies with M.Sc. or a higher degree (Statistics/Biostatistics/Mathematical Statistics/ Applied Statistics) Independently interact with client and handle/address any queries from client Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations. Good knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and other regulatory guidance documents Good knowledge of statistical programming languages (including SAS) and R will be added advantage Adherence to SOPs and GPP Ensure teams compliance to organizational policies and procedures Quality and adherence to timelines. Skills Required RoleExpert Biostatistician Industry TypeITES/BPO/KPO Functional AreaPharmaceutical Required EducationAny Graduates Employment TypeFull Time, Permanent Key Skills BIOSTATISTICIAN CLINICAL TRAILS Other Information Job CodeGO/JC/21471/2025 Recruiter NameSangeetha

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5 - 8 years

0 Lacs

Mumbai Metropolitan Region

On-site

Job Description A minimum of 10 years of total experience in role of biostatistician on clinical studies with M.Sc. or a higher degree (Statistics/Biostatistics/Mathematical Statistics/ Applied Statistics) Independently interact with client and handle/address any queries from client Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations. Good knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and other regulatory guidance documents Good knowledge of statistical programming languages (including SAS) and R will be added advantage Adherence to SOPs and GPP Ensure teams compliance to organizational policies and procedures Quality and adherence to timelines. Skills Required RoleExpert Biostatistician Industry TypeITES/BPO/KPO Functional AreaPharmaceutical Required EducationAny Graduates Employment TypeFull Time, Permanent Key Skills BIOSTATISTICIAN CLINICAL TRAILS Other Information Job CodeGO/JC/21471/2025 Recruiter NameSangeetha

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3 years

0 Lacs

Alirajpur, Madhya Pradesh, India

Hybrid

Job Brief State Program Manager, Madhya Pradesh Vital Strategies India Services Private Limited, is a social enterprise focused on strengthening and revitalizing public health systems to address the leading causes of death, disease, and injury. We deploy our unique world-class technical expertise and global experience to design and support scalable solutions that can bridge the gap between public health needs and their solutions, focusing on rapid, large-scale impact. We leverage our core strengths in the areas of public health intelligence to strengthen the collection and use of data for informed government action, strategic communication to build awareness and behaviour change, institutional strengthening, and innovative financing. In addition to our topical areas of focus – noncommunicable diseases, environmental health and climate change, injury prevention, and social determinants of health we also prioritize work that aims to strengthen the fundamental, foundational dimensions of public health practice that enable governments to tackle and respond to any public health challenge. We welcome applications from people of all backgrounds and do not discriminate based on characteristics such as race, color, age, religion or creed, gender, national origin, ancestry, physical or mental disability, veteran or military status, marital status, or any other basis protected by country and local laws. We are proud of our commitment to a professional work environment where everyone is treated with respect and dignity. Vital Strategies India will not tolerate its employees, volunteers, consultants, partners, or any other representative associated with the delivery of its work carrying out any form of sexual harassment, sexual exploitation, or sexual abuse, and thoroughly vets all final candidates. About the Lead Poisoning Prevention Program: Lead poisoning is a widespread but preventable crisis that affects millions—particularly children—leading to severe cognitive, developmental, and lifelong health consequences. Vital Strategies is expanding its program that addresses the issue of lead poisoning in low- and middle-income countries. We plan to build upon existing efforts and interest by collaborating with governmental agencies in more Indian states to strengthen health systems and build local expertise in lead poisoning prevention to enact sound, cost-effective policies to address exposures. Job Purpose: The State Program Manager will provide technical support in enhancing the state health systems' capacity to reduce lead poisoning. The manager will offer epidemiological and programmatic support, including supporting the design, implementation, and monitoring of blood lead surveillance in the state. With support from the team, the State Program Manager will use data to help the government plan, formulate, and enact sound local public health policies. The role involves collaborating with a team of environmental health scientists, epidemiologists, clinicians, public health professionals, statisticians, and partnering with high-level government officials. Duties and Responsibilities: Technical and programmatic support - Collaborate with a team to provide technical support in the design and implementation of the lead poisoning prevention program; Assist in guiding and building the capacity of government and non-government staff to implement the lead poisoning prevention program; Provide support in the development of a surveillance framework, standardizing surveillance procedures, and obtaining ethical approval; Train and monitor state, district, and field surveillance teams’ activities; Support organizing technical discussions and training for journalists; Provide support on policy analysis; Facilitate training sessions for health officials, frontline workers, journalists, and other stakeholders. Stakeholder Management - Assist in developing and maintaining partnerships with government and non-government stakeholders across various sectors, including health, environment (such as pollution control board), academic and research institutions, etc; In collaboration with the supervisor, serve as a Vital Strategies focal point and representative for key state-level stakeholders. Data management - With designated personnel, monitor data collection, ensure data quality, and manage data sets. Provide on-ground monitoring through regular visits to selected districts; Work with senior epidemiologists to clean, analyze, and report surveillance data ensuring quality of surveillance data. Communication - Create presentations, technical reports, and non-technical summaries for varied audiences, including policy-makers and the general public; Disseminate and present report findings to stakeholders and promote data use for policy and planning. Operations and Administration - Supervise and support a small, dispersed team; Assist with program start-up, logistics, contracting, expense monitoring, activity reporting, and procurement; Oversee payment processing for state program team members and vendors, collaborating with the Finance and Operations teams of the Vital Strategies India office; Communicate regularly with staff assigned to support national heavy metal surveillance and source identification; Coordinate state activities with the initiative’s partner organizations; Assist with other duties assigned by the supervisor. Qualifications: Education - Master’s degree in public health, epidemiology, environmental science, or related public health field (e.g., biostatistics, demography) or public administration, or MBBS. Skills & Abilities - Demonstrated familiarity with public health systems, health programs, disease surveillance programs, and health and environmental risk assessment; Understanding of advocacy for evidence-based interventions and how to navigate bureaucratic processes; Strong organizational skills, with the ability to manage competing priorities and deadlines. Ability to work independently while coordinating with diverse teams and stakeholders; Excellent verbal and written communication skills to convey technical information to diverse audiences. Ability to prepare reports and presentations for decision-makers; Professional oral and written proficiency in English, Hindi, and the state’s native language; Proven ability to interpret public health data, generate actionable insights, and support policy recommendations; Ability to anticipate challenges and identify obstacles, work with team to develop solutions, and remain flexible with shifting program needs; Passion for addressing environmental health challenges and improving community well-being; Solid knowledge of Microsoft Office suite; Ability to build strong, ongoing, impactful relationships at all organizational levels and across a diverse range of cultural, generational, ethnic, racial, educational, and social backgrounds; Demonstrated commitment to valuing diversity and contributing to an inclusive working and learning environment. Experience: Required - Minimum six to seven years of relevant experience, of which at least 3 years should be at the state level; Experience in supporting the design and monitoring of health surveillance programs at the state level or previous experience managing large health-related surveys; Experience working with government health departments, regulatory bodies, and public health facilities; Experience supporting the implementation and monitoring of public health programs at the state level; Experience in designing, managing field data collection, analysis, and reporting; Experience in using data analytic software (e.g. R, Stata, SAS, Excel) and/or data visualization platforms (e.g., Shiny, Tableau); Experience in conducting training sessions; Experience in supervising a small team. Ability to manage a team of 2-3 staff and other program stakeholders at the state level. Preferred - Experience managing complex data flows; Experience in communicating scientific and health information to varied audiences; Experience in using project management platforms such as Monday or Airtable is a plus. Working Conditions and Physical Requirements: Ability to be flexible with colleagues across time zones; Willing to travel for in-person meetings with government, partners, and relevant local stakeholders as required; State-level work experience will be preferred; Must reside at the specified location of service. Additional Information: The salary for this position is in the range of INR 19,77,500 to 24,90,000. To help you stay energized, engaged, and inspired, we offer a wide range of benefits, including a strong retirement plan, flexible basket reimbursement option, comprehensive healthcare, and Paid Leaves so you can relax, recharge, and be there for the people you care about. To Apply: Vital Strategies has engaged Strategic Alliance Management Services Private Limited (SAMS), a premier, pan-India, management consultancy to lead this search. If you are interested in applying or learning more about the position, please follow this link: State Program Managers, Madhya Pradesh, Gujarat, Karnataka

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3 years

0 Lacs

Gujarat, India

Hybrid

Job Brief State Program Manager - Gujarat, India Vital Strategies India Services Private Limited, is a social enterprise focused on strengthening and revitalizing public health systems to address the leading causes of death, disease, and injury. We deploy our unique world-class technical expertise and global experience to design and support scalable solutions that can bridge the gap between public health needs and their solutions, focusing on rapid, large-scale impact. We leverage our core strengths in the areas of public health intelligence to strengthen the collection and use of data for informed government action, strategic communication to build awareness and behaviour change, institutional strengthening, and innovative financing. In addition to our topical areas of focus – noncommunicable diseases, environmental health and climate change, injury prevention, and social determinants of health we also prioritize work that aims to strengthen the fundamental, foundational dimensions of public health practice that enable governments to tackle and respond to any public health challenge. We welcome applications from people of all backgrounds and do not discriminate based on characteristics such as race, color, age, religion or creed, gender, national origin, ancestry, physical or mental disability, veteran or military status, marital status, or any other basis protected by country and local laws. We are proud of our commitment to a professional work environment where everyone is treated with respect and dignity. Vital Strategies India will not tolerate its employees, volunteers, consultants, partners, or any other representative associated with the delivery of its work carrying out any form of sexual harassment, sexual exploitation, or sexual abuse, and thoroughly vets all final candidates. About the Lead Poisoning Prevention Program: Lead poisoning is a widespread but preventable crisis that affects millions—particularly children—leading to severe cognitive, developmental, and lifelong health consequences. Vital Strategies is expanding its program that addresses the issue of lead poisoning in low- and middle-income countries. We plan to build upon existing efforts and interest by collaborating with governmental agencies in more Indian states to strengthen health systems and build local expertise in lead poisoning prevention to enact sound, cost-effective policies to address exposures. Job Purpose: The State Program Manager will provide technical support in enhancing the state health systems' capacity to reduce lead poisoning. The manager will offer epidemiological and programmatic support, including supporting the design, implementation, and monitoring of blood lead surveillance in the state. With support from the team, the State Program Manager will use data to help the government plan, formulate, and enact sound local public health policies. The role involves collaborating with a team of environmental health scientists, epidemiologists, clinicians, public health professionals, statisticians, and partnering with high-level government officials. Duties and Responsibilities: Technical and programmatic support - Collaborate with a team to provide technical support in the design and implementation of the lead poisoning prevention program; Assist in guiding and building the capacity of government and non-government staff to implement the lead poisoning prevention program; Provide support in the development of a surveillance framework, standardizing surveillance procedures, and obtaining ethical approval; Train and monitor state, district, and field surveillance teams’ activities; Support organizing technical discussions and training for journalists; Provide support on policy analysis; Facilitate training sessions for health officials, frontline workers, journalists, and other stakeholders. Stakeholder Management - Assist in developing and maintaining partnerships with government and non-government stakeholders across various sectors, including health, environment (such as pollution control board), academic and research institutions, etc; In collaboration with the supervisor, serve as a Vital Strategies focal point and representative for key state-level stakeholders. Data management - With designated personnel, monitor data collection, ensure data quality, and manage data sets. Provide on-ground monitoring through regular visits to selected districts; Work with senior epidemiologists to clean, analyze, and report surveillance data ensuring quality of surveillance data. Communication - Create presentations, technical reports, and non-technical summaries for varied audiences, including policy-makers and the general public; Disseminate and present report findings to stakeholders and promote data use for policy and planning. Operations and Administration - Supervise and support a small, dispersed team; Assist with program start-up, logistics, contracting, expense monitoring, activity reporting, and procurement; Oversee payment processing for state program team members and vendors, collaborating with the Finance and Operations teams of the Vital Strategies India office; Communicate regularly with staff assigned to support national heavy metal surveillance and source identification; Coordinate state activities with the initiative’s partner organizations; Assist with other duties assigned by the supervisor. Qualifications: Education - Master’s degree in public health, epidemiology, environmental science, or related public health field (e.g., biostatistics, demography) or public administration, or MBBS. Skills & Abilities - Demonstrated familiarity with public health systems, health programs, disease surveillance programs, and health and environmental risk assessment; Understanding of advocacy for evidence-based interventions and how to navigate bureaucratic processes; Strong organizational skills, with the ability to manage competing priorities and deadlines. Ability to work independently while coordinating with diverse teams and stakeholders; Excellent verbal and written communication skills to convey technical information to diverse audiences. Ability to prepare reports and presentations for decision-makers; Professional oral and written proficiency in English, Hindi, and the state’s native language; Proven ability to interpret public health data, generate actionable insights, and support policy recommendations; Ability to anticipate challenges and identify obstacles, work with team to develop solutions, and remain flexible with shifting program needs; Passion for addressing environmental health challenges and improving community well-being; Solid knowledge of Microsoft Office suite; Ability to build strong, ongoing, impactful relationships at all organizational levels and across a diverse range of cultural, generational, ethnic, racial, educational, and social backgrounds; Demonstrated commitment to valuing diversity and contributing to an inclusive working and learning environment. Experience: Required - Minimum six to seven years of relevant experience, of which at least 3 years should be at the state level; Experience in supporting the design and monitoring of health surveillance programs at the state level or previous experience managing large health-related surveys; Experience working with government health departments, regulatory bodies, and public health facilities; Experience supporting the implementation and monitoring of public health programs at the state level; Experience in designing, managing field data collection, analysis, and reporting; Experience in using data analytic software (e.g. R, Stata, SAS, Excel) and/or data visualization platforms (e.g., Shiny, Tableau); Experience in conducting training sessions; Experience in supervising a small team. Ability to manage a team of 2-3 staff and other program stakeholders at the state level. Preferred - Experience managing complex data flows; Experience in communicating scientific and health information to varied audiences; Experience in using project management platforms such as Monday or Airtable is a plus. Working Conditions and Physical Requirements: Ability to be flexible with colleagues across time zones; Willing to travel for in-person meetings with government, partners, and relevant local stakeholders as required; State-level work experience will be preferred; Must reside at the specified location of service. Additional Information: The salary for this position is in the range of INR 19,77,500 to 24,90,000. To help you stay energized, engaged, and inspired, we offer a wide range of benefits, including a strong retirement plan, flexible basket reimbursement option, comprehensive healthcare, and Paid Leaves so you can relax, recharge, and be there for the people you care about. To Apply: Vital Strategies has engaged Strategic Alliance Management Services Private Limited (SAMS), a premier, pan-India, management consultancy to lead this search. If you are interested in applying or learning more about the position, please follow this link: State Program Managers, Madhya Pradesh, Gujarat, Karnataka

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0.0 - 3.0 years

0 Lacs

Madhya Pradesh

On-site

State Program Manager, Madhya Pradesh Vital Strategies India Services Private Limited, is a social enterprise focused on strengthening and revitalizing public health systems to address the leading causes of death, disease, and injury. We deploy our unique world-class technical expertise and global experience to design and support scalable solutions that can bridge the gap between public health needs and their solutions, focusing on rapid, large-scale impact. We leverage our core strengths in the areas of public health intelligence to strengthen the collection and use of data for informed government action, strategic communication to build awareness and behaviour change, institutional strengthening, and innovative financing. In addition to our topical areas of focus – noncommunicable diseases, environmental health and climate change, injury prevention, and social determinants of health we also prioritize work that aims to strengthen the fundamental, foundational dimensions of public health practice that enable governments to tackle and respond to any public health challenge. We welcome applications from people of all backgrounds and do not discriminate based on characteristics such as race, color, age, religion or creed, gender, national origin, ancestry, physical or mental disability, veteran or military status, marital status, or any other basis protected by country and local laws. We are proud of our commitment to a professional work environment where everyone is treated with respect and dignity. Vital Strategies India will not tolerate its employees, volunteers, consultants, partners, or any other representative associated with the delivery of its work carrying out any form of sexual harassment, sexual exploitation, or sexual abuse, and thoroughly vets all final candidates. About the Lead Poisoning Prevention Program: Lead poisoning is a widespread but preventable crisis that affects millions—particularly children—leading to severe cognitive, developmental, and lifelong health consequences. Vital Strategies is expanding its program that addresses the issue of lead poisoning in low- and middle-income countries. We plan to build upon existing efforts and interest by collaborating with governmental agencies in more Indian states to strengthen health systems and build local expertise in lead poisoning prevention to enact sound, cost-effective policies to address exposures. Job Purpose: The State Program Manager will provide technical support in enhancing the state health systems' capacity to reduce lead poisoning. The manager will offer epidemiological and programmatic support, including supporting the design, implementation, and monitoring of blood lead surveillance in the state. With support from the team, the State Program Manager will use data to help the government plan, formulate, and enact sound local public health policies. The role involves collaborating with a team of environmental health scientists, epidemiologists, clinicians, public health professionals, statisticians, and partnering with high-level government officials. Duties and Responsibilities: Technical and programmatic support - Collaborate with a team to provide technical support in the design and implementation of the lead poisoning prevention program; Assist in guiding and building the capacity of government and non-government staff to implement the lead poisoning prevention program; Provide support in the development of a surveillance framework, standardizing surveillance procedures, and obtaining ethical approval; Train and monitor state, district, and field surveillance teams’ activities; Support organizing technical discussions and training for journalists; Provide support on policy analysis; Facilitate training sessions for health officials, frontline workers, journalists, and other stakeholders. Stakeholder Management - Assist in developing and maintaining partnerships with government and non-government stakeholders across various sectors, including health, environment (such as pollution control board), academic and research institutions, etc; In collaboration with the supervisor, serve as a Vital Strategies focal point and representative for key state-level stakeholders. Data management - With designated personnel, monitor data collection, ensure data quality, and manage data sets. Provide on-ground monitoring through regular visits to selected districts; Work with senior epidemiologists to clean, analyze, and report surveillance data ensuring quality of surveillance data. Communication - Create presentations, technical reports, and non-technical summaries for varied audiences, including policy-makers and the general public; Disseminate and present report findings to stakeholders and promote data use for policy and planning. Operations and Administration - Supervise and support a small, dispersed team; Assist with program start-up, logistics, contracting, expense monitoring, activity reporting, and procurement; Oversee payment processing for state program team members and vendors, collaborating with the Finance and Operations teams of the Vital Strategies India office; Communicate regularly with staff assigned to support national heavy metal surveillance and source identification; Coordinate state activities with the initiative’s partner organizations; Assist with other duties assigned by the supervisor. Qualifications: Education - Master’s degree in public health, epidemiology, environmental science, or related public health field (e.g., biostatistics, demography) or public administration, or MBBS. Skills & Abilities - Demonstrated familiarity with public health systems, health programs, disease surveillance programs, and health and environmental risk assessment; Understanding of advocacy for evidence-based interventions and how to navigate bureaucratic processes; Strong organizational skills, with the ability to manage competing priorities and deadlines. Ability to work independently while coordinating with diverse teams and stakeholders; Excellent verbal and written communication skills to convey technical information to diverse audiences. Ability to prepare reports and presentations for decision-makers; Professional oral and written proficiency in English, Hindi, and the state’s native language; Proven ability to interpret public health data, generate actionable insights, and support policy recommendations; Ability to anticipate challenges and identify obstacles, work with team to develop solutions, and remain flexible with shifting program needs; Passion for addressing environmental health challenges and improving community well-being; Solid knowledge of Microsoft Office suite; Ability to build strong, ongoing, impactful relationships at all organizational levels and across a diverse range of cultural, generational, ethnic, racial, educational, and social backgrounds; Demonstrated commitment to valuing diversity and contributing to an inclusive working and learning environment. Experience: Required - Minimum six to seven years of relevant experience, of which at least 3 years should be at the state level; Experience in supporting the design and monitoring of health surveillance programs at the state level or previous experience managing large health-related surveys; Experience working with government health departments, regulatory bodies, and public health facilities; Experience supporting the implementation and monitoring of public health programs at the state level; Experience in designing, managing field data collection, analysis, and reporting; Experience in using data analytic software (e.g. R, Stata, SAS, Excel) and/or data visualization platforms (e.g., Shiny, Tableau); Experience in conducting training sessions; Experience in supervising a small team. Ability to manage a team of 2-3 staff and other program stakeholders at the state level. Preferred - Experience managing complex data flows; Experience in communicating scientific and health information to varied audiences; Experience in using project management platforms such as Monday or Airtable is a plus. Working Conditions and Physical Requirements: Ability to be flexible with colleagues across time zones; Willing to travel for in-person meetings with government, partners, and relevant local stakeholders as required; State-level work experience will be preferred; Must reside at the specified location of service. Additional Information: The salary for this position is in the range of INR 19,77,500 to 24,90,000. To help you stay energized, engaged, and inspired, we offer a wide range of benefits, including a strong retirement plan, flexible basket reimbursement option, comprehensive healthcare, and Paid Leaves so you can relax, recharge, and be there for the people you care about. To Apply: Vital Strategies has engaged Strategic Alliance Management Services Private Limited (SAMS), a premier, pan-India, management consultancy to lead this search. If you are interested in applying or learning more about the position, please follow this link: State Program Managers, Madhya Pradesh, Gujarat, Karnataka #LI-Hybrid

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0 - 2 years

0 Lacs

Hyderabad, Telangana, India

On-site

Job title: Pharmacovigilance Periodic Reporting Oversight Specialist Location: Hyderabad Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission: to bring health in people’s hands by making self-care as simple as it should be for over half a billion consumers worldwide. At the core of this mission is our 100+ loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and four specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets; we are active players in the journey towards healthier people and planet. Find out more about our mission to bring health in your hands at www.opella.com. Main Responsibilities The PRM Oversight Team are the specialists on the regulatory requirements (CH GVP, ICH, CFR etc.) and process owners for the authoring Global periodic safety reports (PSRs) coordinated by Opella Global Pharmacovigilance (Opella PV).The PRM Oversight Team is the Opella GPV representative in inspections and audits responsible for explaining PSR authoring processes owned by the PRE Team.The PRM Oversight is responsible for providing responses to Health Authority Assessment reports regarding PSR content in collaboration with the Global Safety Officer (GSO), Global Safety Sciences and Qualified Person for Pharmacovigilance (QPPV) when applicable.Through content authoring and project management activities, the PRM Oversight ensures Global continuity of the safety messaging within PSRs across applicable regulatory submission documents (RMP, DSUR, RSI) to support final approval and signature by the GSO/QPPV.The PRM Oversight team assures PSR submission compliance to global regulatory authorities by fostering productive and supportive relationships with internal participants (GSO, QPPV, Risk Management Office, Global Safety Sciences, System Support Unit) and PSR contributors external to Opella GPV (Global Business Units, Medical functions, Global Regulatory Affairs, Biostatistics and Programming, Clinical Science Operations).The PRM Oversight drives continuous improvement for periodic reporting processes and quality documents.The PRM Oversight team oversees vendors participating in periodic reporting activities, provides clear guidance on process expectations and productive feedback to ensure adherence to quality document requirements.The PRM Oversight is the centralized Opella PV expert on the regulatory framework for Global PSRs.Provides Global PSR format training and support to contributors.Participates in inspections and audits to communicate PSR processes and expectations as defined in quality documents.The PRM Oversight team implements process and quality document changes when regulatory requirements change, or process improvements are identified.The PRM Oversight authors and coordinates the pharmacovigilance content, including signal detection analyses, for Global PSRs with respect to the cumulative product experience.The PRM Oversight is the expert in systematically assessing relevant product content for inclusion in PSRs from available regulatory and product monitoring documentation.Leads and manages the cross-functional coordination of PSRs and Global PV contribution to PSRs to ensure regulatory submission compliance.Leads the authoring of Global PSRs according to an existing outsourcing strategy.The PRM Oversight is expected to foster productive relationships with cross-functional teams that appropriately represent the PRE team as a whole.Accountable for complying to PRM Oversight timelines, accurate tracking of contributions from contributors and communicating report quality expectations.Responsible for management escalation regarding non-compliance to PSRs timelines, quality expectations, and proceduresAccountable for the maintenance of the appropriate documentation utilized during Global PSR authoring.Participate in Health Authority assessment report responses, inspections, and internal and partner audits regarding the Global PSR processes.Responsible for responding to health authority and partner questions regarding the Global PSR content and processes.Responsible for onboarding, training, and supporting outsourcing vendors to ensure compliance to internal and regulatory process and quality requirements.Provide ongoing productive support and feedback to the vendor to ensure adherence to Opella policies and quality expectationsRequired to track and report recurrent vendor quality issues to management.Responsible for participating in or managing vendor meetings.Provide quality and compliance oversight of vendor activities for Opella Periodic Reports (PBRER/DSUR/SASR/etc.) and continuous improvement of processes:Oversight for PSR-related activities performed by vendorData collection of PBRER KPI’s and documentation of these in Quality trackerQuality findings from QC checklists uploaded in Veeva vault are checked and entered in Quality trackerTimeline guides for PBRER checked and delays (if any, along with the reason for delay) are documented in Quality trackerProvide assessment of critical findings in the Quality trackerManage and support quality and compliance trending/metrics/KPIs/ Scorecard(s) of periodic reports (i.e. HA, PBRER, DSUR, SDEA)Kick Off meeting management and conductContinuous Improvement of PSR processesNew QDs & training plan/documentation for Opella PV Periodic Reports team – maintain quality documents, updated with the new regulations and Opella processes.Organizational ReadinessAccountable for complying to timeline expectations and for the accurate and reliable tracking of quality and compliance metrics for Global PSRsSupport/provide the root cause analyses associated with quality and compliance deviationsManage and provide support for Local PBRER/Business partner requestsParticipate and provide contributions for the Periodic Partner Compliance Review Meeting (PPCRM Survey), relating to any deviation matters identified in respective activities involving Opella Business Partners Experience About you Overall 5-6 years of experience Pharmacovigilance Aggregate Safety Reports, Medical Writing, and Periodic safety reportsExperience in PBRER planning and authoringProactive and strong project management experience including multi-tasking of deliverables with competing timelinesFlexibility to adapt to changing priorities and delaysFluency in ICH and GVP guidelines regarding periodic safety report contentKnowledgeable in PSR relevant regulations across major markets including but not limited to EU, US, China, Brazil, Japan, Canada etc.,Comfortable leading cross-functional meetings in EnglishStrong interpersonal skills and the ability to collaborate productively in an international and multi-cultural environmentProficiency in Microsoft applications (Word, Power Point, Excel)Fluent spoken and written EnglishIncumbent should have experience in Process Improvement practices Soft Skills Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions.Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities.Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.Excellent team-work and interpersonal skillsAbility to work in cross-functional teamsExcellent oral and written communication skillsStrong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Technical Skills Regulatory Standards, Good Pharmacovigilance Practices (GxP), Safety Reporting RequirementsDatabase Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data.Software Testing/Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgradesReport Writing: Ability to write clear, concise, and accurate reports, including regulatory reports, internal analyses, and safety assessments. This includes the ability to translate complex data into understandable narratives.Business Intelligence Tools: Experience with tools like Power BI, or Spotfire to create visual reports and dashboards for stakeholders.Leadership, Teamwork and Management skillsGood interpersonal skillsExcellent project management skillsStrong decision-making skillsStrong knowledge of worldwide pre and post marketing safety reporting regulations and requirements and ICH Education Healthcare Professional / Life science Graduate or Equivalent with a 5-year minimum experience of Pharmacovigilance Safety Reports relevant experience Languages: Fluent in English (verbal and written) Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We Are Dedicated To Making Self-care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers

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3 - 7 years

14 - 17 Lacs

Hyderabad

Work from Office

Global HEOR Value Writing Leader What you will do Let’s do this. Let’s change the world. In this vital role you will serve as the operational head for a team of Global HEOR Value Writers (L5) supporting Amgen’s global market access and reimbursement. This role is accountable for ensuring the timely and high-quality development of payer- and HTA-relevant deliverables including Global Value Dossiers (GVDs), AMCP dossiers, early HTA briefing books, reports and scientific publications across multiple therapeutic areas. The Global HEOR Value Writing Leader aligns closely with the Global Head HTA Strategy & Project Management and the Global HEOR Product Leads on plans and timelines for the relevant deliverables. Lead, handle, and mentor a team of Global HEOR Value Writers, fostering a high-performance culture. Lead all aspects of development, review, and quality control of value writing deliverables including GVDs, AMCP dossiers, early HTA briefing materials, reports and scientific publications across multiple pipeline and inline products. Align with Head HTA Strategy & Project Management to ensure deliverables follow product strategy and deliverable timelines. Align with the relevant Amgen processes. Serve as an expert on payer- and HTA-relevant writing materials. Collaborate with Head HTA Strategy & Project management to implement process improvements to speed up delivery of payer- and HTA-relevant materials. Contribute to hiring, training, and performance evaluations within the team. Ensure compliance with all regulatory and quality policies and standards. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The HEOR Value Writing Leader we seek should possess these qualifications. Basic Qualifications & Experience: Doctorate degree in health economics, public health, pharmacy, life sciences, biostatistics or a related field and 2 years of experience in HEOR, Medical or Regulatory writing in the pharmaceutical, biotech, or consulting setting OR, Master’s degree in health economics, public health, pharmacy, life sciences, biostatistics or a related field and 8 to 10 years of experience in HEOR, Medical or Regulatory writing in the pharmaceutical, biotech, or consulting setting OR, Bachelor’s degree in health economics, public health, pharmacy, life sciences, biostatistics or a related field and 10 to 14 years of experience in HEOR, Medical or Regulatory writing in the pharmaceutical, biotech, or consulting setting OR, Diploma in health economics, public health, pharmacy, life sciences, biostatistics or a related field and 14 to 18 years of experience in HEOR, Medical or Regulatory writing in the pharmaceutical, biotech, or consulting setting Proven experience in leading the development of GVDs, AMCP dossiers, and other HTA-related documents. 3+ years of experience in team management capacity. Skills & Competencies: Strong leadership and team management abilities. Excellent English oral and written communication, with ability to tailor content to different key partners. Advanced understanding of clinical, economic, and real-world data and their application in market access. Expertise in global HTA processes, payer evidence requirements, and value demonstration standard methodologies. Knowledge of Good Publication Practice and publication submission process Proficiency in Microsoft Office and reference management tools (e.g., EndNote). Innovative use of artificial intelligence to boost efficiency. Organizational Behaviors: Proactive, collaborative, and solutions-focused leadership style. Strong project management and decision-making capabilities in a dynamic, distributed team environment. Comfortable working in a distributed team across time zones and cultures. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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7 - 12 years

20 - 30 Lacs

Hyderabad

Remote

Primary Job Function Responsible for the integrity of the programming/computing solutions for multiple clinical trials (or equivalent) and/or publication activities. In collaboration with the Biostatistician and Senior Programmer, provide programming support to project-level programming deliverables and other adhoc programming requests. Roles and Responsibilities Ensure understanding and compliance with study and project programming standards. Responsible for development of programming specification. Create and Validate Safety and Efficacy Analysis Datasets in adherence with CDISC and client specific standards and maintain quality and accuracy. Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy. Create Study specific or general macros and finalize programming specifications/mock-ups. Adhere to programming specifications and study specific requirements, including completion and filing of required documentation. Plan and organize workload to ensure effective time management and adherence to project specific timelines. Proactively plan for and implement effective resource planning, task allocation and tracking of workload in accordance with agreed KPIs and quality standards Trouble-shoot and resolve programming issues in a timely and efficient manner. Ability to work independently and as part of a team environment. Strong problem solving and organizational skills, attention to detail, verbal and written communications skills Desired Candidate Profile Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy. Very strong SAS programming skills required in SAS/Base, PROC SQL,SAS/Stat, SAS Macros and SAS/Graph (Base and Advance SAS). Good communications and negotiation skills, ability to work well with others globally.

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4 - 8 years

15 - 18 Lacs

Hyderabad

Work from Office

Global HEOR Economic Modeling Leader What you will do Let’s do this. Let’s change the world. In this vital role you will serve as an operational and technical leader responsible for overseeing a team of Global HEOR Economic Modelers. This role ensures the development of innovative, scientifically rigorous, and high-quality economic models supporting Amgen’s global market access and pricing strategies. The position requires close collaboration with Global HEOR TA Heads to align health economics deliverables with product strategies. Lead, mentor, and develop a team of Global HEOR Economic Modelers to ensure dedication and continuous professional growth. Provide technical direction and oversight for the development of economic models, including cost-effectiveness/cost-utility (e.g., markov, partitioned survival model), cost minimization, budget impact, and other techniques, as appropriate. Drive innovation and standardization in health economic modeling methodologies across portfolio. Ensure alignment of modeling activities with HEOR TA Heads and product strategies. Maintain expert-level understanding of global HTA requirements and evolving payer needs, integrating them into the team’s economic modeling approaches. Oversee model documentation and ensure quality control and compliance with internal and external standards. Contribute to hiring, training, and performance evaluations within the team. Continuously improve workflows, tools, and methodologies to enhance efficiency and quality of work. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Economic Modeling Leader we seek should possess these qualifications. Basic Qualifications: Doctorate degree in Health Economics, Econometry, Biostatistics, Mathematics, Engineering or a related field and 2 years of experience in health economic modeling within the pharmaceutical, biotechnology, or consulting sectors OR, Master’s degree in Health Economics, Econometry, Biostatistics, Mathematics, Engineering or a related field and 8 to 10 years of experience in health economic modeling within the pharmaceutical, biotechnology, or consulting sectors OR, Bachelor’s degree in Health Economics, Econometry, Biostatistics, Mathematics, Engineering or a related field and 10 to 14 years of experience in health economic modeling within the pharmaceutical, biotechnology, or consulting sectors OR, Diploma in Health Economics, Econometry, Biostatistics, Mathematics, Engineering or a related field and 14 to 18 years of experience in health economic modeling within the pharmaceutical, biotechnology, or consulting sectors 3+ years of experience in team management capacity. Consistent track record of supporting HTA submissions and payer evidence generation globally. Expert proficiency with modeling and statistical tools such as Excel, R, SAS, or STATA. Skills & Competencies: Strong leadership and key customer engagement skills. Excellent English oral and written communication, with ability to tailor content to different customers. Advanced quantitative and analytical abilities with exceptional attention to detail. Deep knowledge of HTA processes and payer landscapes across major markets. Innovative use of artificial intelligence to boost efficiency. Organizational Behaviors: Proactive leadership with a collaborative approach. Comfortable working in a distributed team across time zones and cultures. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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2 years

0 Lacs

Bengaluru, Karnataka

Work from Office

Biostatistician I / II - India - Office Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Biostatistician I to join our diverse and dynamic team. As a Biostatistician II at ICON, you will play a pivotal role coordinating and supervising the work of biostatisticians and programmers, ensuring timely and high-quality deliverables for assigned studies. What you will be doing: Contribute to the design of case report forms with a focus on statistical aspects. Review study database structures, edit checks, and data management coding conventions to ensure data integrity. Prepare comprehensive statistical analysis plans, defining derived data and crafting statistical tables, figures, and data listings for clinical summary reports. Conduct statistical analyses to extract meaningful insights from research data. Interpret data and effectively communicate findings through result reporting. Collaborate on writing the statistical methods sections of integrated study reports. Your Profile: A Master's degree or higher in statistics or related field Demonstrated experience of 2+ years in statistics, biostatistics, or a related field within the pharmaceutical industry is required. Strong kNwledge of study designs and statistical analysis conventions in one or more therapeutic areas. Exceptional verbal and written communication skills and proficient computer skills. Strong familiarity with clinical trials methodology, regulatory requirements, statistics, and proficiency in statistical software packages, including SAS. Ability to translate clients' needs into statistical practices and educate clients in the utilization of statistical methods, coupled with solid interpersonal and project management skills. #LI-KT1 What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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0.0 - 1.0 years

1 - 3 Lacs

West Mambalam, Chennai

On-site

Medical Coding Job for Freshers : (2019 to 2024) Passed out Medical Coding Jobs For Fresher 2024 Passed Out NOTE: JOB LOCATION - CHENNAI, COIMBATORE, TRICHY, SALEM, VELLORE Job Description: Position: Medical Coder Medical Coding is the process of converting Verbal Descriptions into numeric or alpha numeric by using ICD 10-CM, CPT & HCPCS. Requirement: knowledge in Anatomy and Physiology Good communication and interpersonal skills Basic Computer Skills 9Life science & Paramedical Graduates No of vacancy: 700 Eligibility: Nursing GNM/DGNM Life science graduates Pharmacy Physician assistant Bio medical Engineers Bio chemistry Bio technology Bio informatics Micro biology Zoology and Advanced zoology Biology Botany Plant biotechnology Genetics Food and Nutrition Paramedical Physiotherapy M.Sc. Clinical Nutrition M.Sc. Human Genetics M.Sc. Medical Laboratory Technology M.Sc. Medical Sociology M.Sc. Epidemiology M.Sc. Molecular Virology M.Sc. Biostatistics M.Sc. Blood Banking Technology M.Sc. Regenerative Medicine M.Sc. Optom. M.Sc. Genetic Counseling M.Sc. Radiology & Imaging Technology M.Sc. Medical Biochemistry M.Sc, Medical Microbiology M.Sc. Clinical Care Technology M.Sc. Clinical Care Technology M.Sc. Medical Physics B.Sc. - Accident & Emergency Care Technology B.Sc. - Audiology & speech Language Pathology B.Sc. - Cardiac Technology B.Sc. - Cardio Pulmonary Perfusion Care Technology B.Sc. - Critical Care Technology B.Sc. - Dialysis Technology B.Sc. - Neuro Electrophysiology B.Sc. - M.L.T. B.Sc. - Medical Sociology B.Sc. - Nuclear Medicine Technology B.Sc. - Operation Theatre & Anaesthesia Technology B.Sc. - Optometry B.Sc. - Physician Assistant B.Sc. - Radiology Imaging Technology B.Sc. - Radiotherapy Technology B.Sc. - Medical Record Science B.Sc. - Respiratory Therapy B.Sc. - Fitness and Lifestyle Modifications Accident & Emergency Care Technology Critical Care Technology Nursing Aide Operation Theatre & Anesthesia Technology Ophthalmic Nursing Assistant Medical Record Science Optometry Technology Radiology & Imaging Technology Medical Lab Technology Cardiac Non-Invasive Technology Dialysis Technology Dentist Salary 14.5K to 17K (fresher) To 50K (experienced) Pm (Incentives & Benefits as per Corporate Standards) 4K fixed hike after six months Other Benefits: weekend Off Only dayshift Pick up and drop Cab provided

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0.0 years

0 Lacs

Chandigarh

On-site

DEPARTMENT OF BIOCHEMISTRY, PANJAB UNIVERSITY, CHANDIGARH (DST-FIST & UGC-SAP SUPPORTED DEPARTMENT) Ph: 0172-25341 31, e-mail: biochem@pu.ac. in Ref. No./BCH/24/_ 140 1947 Date 2o24 Walk In Interview Walk-in-Interview for appointing Guest Faculty to teach Pre-Ph.D, Course work (Biostatistics) for the year 2024 will be held on 12lbulso2y at A:39 pmjn the office of the Chairperson. Department of Biochemistry. PU, Chandigarh ds per the following tentative schedule: Days of teaching Class(es) to be taught Subject to be Working hours taught Monday to Friday Pre-Ph.D, Course work Biostatistics 9:00 AM to 5:00 PM All the applicants are advised to bring their original certificates and other relevant documents for verification along with the duly filled form giving the details at the time of interview (10:00 am reporting time). The application form for the post of Assistant Professor is available at website (http:jobs.puchd.ac.in/forms.php pages 1 to 9). The above assignment willb e on lecture basis witha token honorarium of Rs. 1500/- per lecture with an upper limit of Rs. 50,000/- per month. The candidate shal have to give an undertaing that he/she willn ot draw any fellowship/ stipend or any financial assistance from any agency till they are teaching in the Department of Biochemistry as a Guest Faculty. The candidates who are already availing JRF scholarships in the University are not entitled for the honorarium but they will be issued experience certificate for the guest faculty. Minimum qualifications for the posts are as per UGCn orms. Qualification for the post of one (01) guest faculty (Biostatistics): (i) M.Sc. Degree in Statistics/ Mathematics or allied subject with good academic record as defined by the concerned University with at least 55% marks (50% marks for SC/ST) or an equivalent grade in a point scale wherever grading system is followed at the Master's degree level in Biochemistry/ allied subject from an Indian University or an equivalent degree from an accredited foreign University. (ii) Besides fulfilling the above qualifications, the candidate must have cleared the National Eligibility Test (NET) conducted by the UGC and/or Ph.D. ekrAaarjit Singh Naura) 1Chairpersoniocheaistry Panjab University Chandigerh

Posted 1 year ago

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