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10.0 - 15.0 years

20 - 25 Lacs

Kolkata, Mumbai, New Delhi

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Alvotech is looking to hire a Senior Principal Scientist to lead and innovate within our clinical pharmacology team . This role offers the opportunity to make a significant impact on our clinical programs and contribute to the development of groundbreaking therapies. We seek a highly experienced scientist with a deep understanding of clinical pharmacology, PKPD analysis, and population modelling. Your expertise will be crucial in designing and planning clinical trials, developing regulatory documents, and ensuring compliance with global standards. At Alvotech, you will play a key role in our mission to improve global access to affordable medicines. You will be part of a dynamic team dedicated to scientific excellence and innovation, enjoying a collaborative work environment, opportunities for professional growth, and the chance to contribute to transformative therapies. Please note that international travel may be required to support departmental activities. Scope Responsibilities: Lead clinical pharmacology activities for assigned clinical programs/trials. Develop and revise relevant sections of regulatory documents and deliverables. Develop the clinical pharmacology strategy, briefing book, study design, and protocol development. Collaborate with biostatisticians on Statistical Analysis Plans (SAPs) and review mock-up displays for tables, listings, and figures. Provide statistical consultation to clinical teams and support decision-making processes. Ensure GCP compliance and high-quality standards for Alvotechs sponsored clinical trials. Support internal and external resources in assay development and validation. Work independently and as part of a multifunctional team to achieve project deliverables. Job Requirements: Masters Degree in a related discipline (PhD in Clinical Pharmacology or related discipline with relevant experience is desirable). Minimum 10 years of experience in clinical trials or clinical pharmacology. Expertise in PKPD analysis, population modelling, and simulation. Experience with large molecules and biosimilars is desired. Excellent written and verbal communication skills. Proficiency in technical software such as Phoenix, WinNonlin, SAS, R, Monolix, and NONMEM. Strong organizational and management skills. Deep knowledge of ICH-GCP and regulatory guidelines. Proven ability to collaborate effectively within cross-functional teams. Strong interpersonal skills, including the ability to build team spirit and communicate openly. What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change peoples lives. The chance to be part of a global and fast-growing company. An international work culture that encourages diversity, collaboration, and inclusion. Positive, flexible, and innovative work environment. A clear and developed organizational structure. Training and global opportunities to advance. A good work-life balance. Home internet and home office equipment. Why Alvotech At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment. True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let s create a healthier world together, through affordable biologic medicines.

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6.0 - 10.0 years

8 - 12 Lacs

Mumbai

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Summary The Principal Biostatistician is responsible for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. May support project level deliverables for a development project with supervision. Leads implementation of modern and innovative clinical trial/experimental designs, statistical models, analyses and data exploration at the study level. About the Role Major Accountabilities:- 1. Study level: a. Responsible for all statistical tasks on assigned trials, and perform these tasks independently seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, reporting activities. Contribute to planning and exe-cution of exploratory analyses, and/or PK, PK/PD analyses, exploratory bi-omarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician. b. Explain statistical methodology and interpret analysis results. Provide statisti-cal expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. c. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, confer-ences, scientific meetings. d. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness of status and issues related to the as-signed trials. e. Collaborate with other line functions. Explain statistical concepts in manner easily understood by non-statisticians and provide adequate statistical justifi-cations for actions/decisions/statements as required. f. Establish and maintain sound working relationships and effective communica-tion within the Clinical Trial Team and Biostatistics & Pharmacometrics team. g. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. 2. Project level: a. Contribute to project level activities as needed. b. Contributes to project team preparation for HA Advisory Committees and meetings. 3. Franchise or Global Line Function level: Contribute to initiatives at global line function level 4. Enterprise level: a. Participate in non-clinical project activities as needed b. Contribute to the review and implementation of health authority guidance c. Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer re-viewed journals and presentations at professional meetings 5. External level: a. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. b. Represent Novartis in statistical discussions at external congresses, confer-ences, scientific meetings. 6. People Management: Mentor new hires and/or junior Statisticians Minimum Requirements: 1. Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives. 2. Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e. g. SAS, R). Knowledge of drug development and Health Authority guidelines. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives. 3. Experience in Franchise/Therapeutic Area and/or regulatory activities desirable. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork. novartis. com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

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9.0 - 13.0 years

25 - 30 Lacs

Bengaluru

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The job holder will be a part of the Scenario Design Team which is involved in designing, maintaining and enriching regulatory and management stress scenarios for the Bank at group and country level. They will be expected to become the subject matter expert on all areas relating to climate risk macroeconomics and help with the design and development of the modelling capacity to produce climate risk scenario expansions. As part of the 2LoD Scenario Design team they will be also expected to review non-climate related scenario narratives and projections produced by 1LoD. This will include generating ideas about which type of scenarios to run for management and regulatory stress tests, producing papers for example for Expert Panels and Committees and presenting to senior management. The role will, in particular, support the Head of the Scenario Design Team with key activities as set out below: Key Responsibilities Strategy Design regulatory and non-regulatory macroeconomic and climate risk scenarios. Perform review and challenge and when required scenario expansion of key climate and non-climate risk economic variables across the Group s diverse footprint. Present baseline and alternative scenarios to senior managers in forums, expert panels and committees. Contribute to committee papers, structured data requests and other internal or external scenario-related reports. Foster good working relationships and solicit input from Global Businesses and Global Functions and, where relevant, external vendors to enhance scenarios. Contribute to the development of a robust operational risk framework for scenario design processes Stay informed of all regulatory and industry developments related to the scenario work stream. Business Broad awareness and understanding of business model and risk profile. Understanding of the bank s existing enterprise risk management framework, governance of the ERMF related requirements, wider stress testing and scenario analysis capabilities and existing processes, with an understanding of the climate risk stress testing and scenario analysis approach Skills and Experience Understanding of various scenario families including NGFS, IPCC, and IEA scenarios Understand and translating transmission channels of climate risks into financial system impacts Familiarity with industry leading climate risk models and climate/ESG data providers, with fluency in the scope, capabilities, and limitations of each tool and platform Understanding of regulatory expectations with respect to climate risks including capital frameworks etc Experience in dealing with large complex, change projects and/or building / delivering new capabilities A proven track record of liaising across diverse stakeholder groups; including senior managers, and large firm networks Qualifications Work experience as economist (macroeconomic or environmental economist), econometrician or quantitative analyst. Prior experience of developing projections in a banking environment. Collaborative: working as part of a broader team to ensure a coordinated and consistent approach Good organiser of incoming requests within the team Ability to work with minimal direction Attention to detail Proactive, problem-solving, helpful Strong experience in MS Excel and Power Point Experience with coding in SAS, R, Python

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2 - 3 years

7 - 12 Lacs

Pune

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Responsibilities Learning and striving to become independent in the analysis of actuarial services and This includes gathering and organizing information and statistical and numerical analysis, with consideration to timing required and quality of work documentation needed. Identify areas for improvement and make recommendations to do so, including the development and implementation of new procedures and systems. Work will be under direction of a reviewer and supervisor. Provide technical assistance to internal and external customers involving research, statistical and numerical analysis of the reports, and solving questions and Present results to the appropriate audience. Determine and discuss clients goals and make recommendations to meet client s needs through proactively consulting. Assist with client meeting material Complete actuarial services and reports timely to meet governmental and client deadlines, as well as business unit and department performance Perform other job-related duties and special projects as Qualifications Bachelors degree in mathematics or related field, or equivalent, and at least one and up to 4 CT (CP) series exams passed. 2 to 3 year of experience. Strong analytical, communication, organizational and prioritization, and decision-making skills. Knowledge of spreadsheet and database or similar PC software packages and aptitude in programming languages is Prior exposure to VBA/SAS/R or any other data tool.Prior Internship Experience would be an added advantage Additional Information The candidate will be expected to develop skills and work in close collaboration with others. He/She will be expected to work in alignment of organizational priorities, Principals culture and our Core LinkedIn Remote Hashtag #LI-Remote

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3 - 5 years

9 - 10 Lacs

Hyderabad

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Senior Scientific Officer - Analytical Support ICRISAT seeks applications from highly motivated and qualified professionals for the position of Senior Scientific Officer-Analytical Support to support the Program Office under Accelerated Crop Improvement. There are two vacancies for this position. The Position will be based in the headquarter, Patancheru, Telangana, India. ICRISAT is a non-profit, non-political organization that conducts agricultural research for development in Asia and sub-Saharan Africa with a wide array of partners throughout the world. Covering 6.5 million square kilometers of land in 55 countries, the semi- arid or dryland tropics has over 2 billion people and 644 millions of these are the poorest of the poor. ICRISAT and its partners help empower these disadvantaged populations to overcome poverty, hunger and a degraded environment through better agricultural production systems. ICRISAT is headquartered at Patancheru near Hyderabad, India, with two regional hubs and eight country offices in sub-Saharan Africa. ICRISAT envisions prosperous, food-secure and resilient dryland tropics . Its mission is to reduce poverty, hunger, malnutrition and environmental degradation in the dryland tropics. ICRISAT conducts research on its mandated crops of chickpea, pigeonpea, groundnut, sorghum, pearl millet and finger millet in the arid and semi-arid tropics. The Institute focuses its work on drylands and on protecting the environment. Tropical dryland areas are usually seen as resource-poor and perennially beset by shocks such as drought, thereby trapping dryland communities in poverty and hunger and making them dependent on external aid. Please visit - www.icrisat.org Responsibilities: Assist ICRISAT s scientists in the planning of agricultural field trials. Generate randomizations and trial layouts for field trials. Provide support to ICRISAT s scientists for data curation, simple and complex analysis and interpretation of the results from field and field-related trials. Develop and/or refine existing SAS /R /ASReml-R codes for data curation, analysis and visualization. Actively contribute to scientific publications in peer reviewed journals. Contribute to conducting training programmes for both ICRISAT s scientists and National Agricultural Research Scientists (NARS) in experimental design, efficient data collection, and data analysis. Perform any other task assigned by the supervisor. Qualifications: Masters/Ph.D in Statistics/Agricultural Statistics. A Min 3 year s experience in agricultural research. Technical Competencies/Skills: Generating modern experimental designs in field trials. Knowledge of multi-environment trial analyses using mixed-models, spatial and stability analyses, heritability and genetic gain estimations of field trials. Use of statistical software such as SAS, GENSTAT, R and ASREML-R and Python. Fluency in spoken and written English. Good Interpersonal skills, communication, and teamwork. General: This is a contractual position for a period of 36 months. How to apply: Applicants should apply on or before 1 April 2025 with their latest Resume, and the names and contact information of three references that are knowledgeable about their professional qualifications and work experience. All applications will be acknowledged; however, only short-listed candidates will be contacted. ICRISAT is an equal opportunity employer

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5 - 8 years

7 - 10 Lacs

Bengaluru

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We are seeking a Senior Specialist Programmer for PKPD / Pharmacometric Data Programming. This role focuses on all aspects of data preparation, programming, validation, and diagnostics to support Pharmacometric and clinical pharmacology analyses at the study levels. You will be instrumental in influencing critical decision-making throughout all phases of drug development and regulatory interactions. Accountabilities: As a Senior Specialist Programmer, you will be accountable for expert data integration, manipulation, and preparation results at the study level. You will execute state-of-the-art data preparation techniques with direct value for the study. Your responsibilities will include collating, cleaning, and preparing analysis-ready data for Pharmacometric Modeling and Simulation (M&S) software (e.g., NONMEM) to influence study designs and go/no-go decisions. You will also contribute to regulatory documents and interactions, internal initiatives to develop the Pharmacometric discipline, and compliance with Good Clinical Practice (GCP) regulations. Essential Skills/Experience: Proficient oral and written English communication skills Demonstrated expertise in data preparation and programming to support Pharmacometric Modeling and Simulation (M&S) software (e.g., NONMEM, Monolix, R, Matlab) Strong SAS/R programming skills Expert knowledge of data preparation and programming practices (CDISC, SDTM, ADaM) Demonstrated data programming and clinical development expertise Good knowledge of global regulatory, compliance, processes, standards Bachelor s degree or Masters preferred with 5 to 8 years relevant experience required Varied programming languages (SAS, R, Python) Experience in early and late-stage drug development Quantitative/Scientific background (Statistics, Engineering, Biological Science) Desirable Skills/Experience Scientific publishing in the field of pharmacometrics Knowledge in pharmacology, drug targets, and core Therapy areas (e.g., Oncology, Respiratory, Renal Metabolism etc.) Relevant regulatory experience

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