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8.0 - 11.0 years
20 - 25 Lacs
Chennai
Work from Office
Accountable for multiple projects/ongoing work activities (timelines, work plans, deliverables) of moderate complexity within a Work Team Accountable for their assigned work supporting the standards/study deliverables and also to assist SDSL s with the team assignments. Review/Develop/Validate/Review datasets, TFL as per CDISC aligned Pfizer Standards or Pfizer Data Standards for Study/Project/Portfolio. (Portfolio) Contributes to upto 80% of their time to programming deliverables assigned within the scope of the function in either SAS, R or Python and 20% to self learning, development and growth. Explore the existing code base and execute/perform runs as required, also develop/modify as per the needs and specifications suggested to the standards team as appropriate - (Standards Programming) Ensures appropriate documentation and QC across the lifespan of the study for all of their programming deliverables across Standards, Programming and Submissions. Understand/Implement standard / study / project / portfolio requirements and specification and work with global stakeholders in ensuring completion of project/study/deliverable goals and milestones Knowledgeable in core safety standards as well as TA standards pertinent to their project and lead development of standards necessary for their study Exhibits routine and occasionally complex problem solving skills, seeking direction when appropriate. Regularly update leads on progress and time estimations to ensure smooth daily operations and accurate planning Support in accomplishing department and organization mission by completing assigned tasks Acts as mentor to junior team members Advances job knowledge to next level by participating/contributing in/to opportunities both globally and locally. Work Location Assignment: Hybrid Medical #LI-PFE
Posted 4 weeks ago
2.0 - 3.0 years
3 - 4 Lacs
Bengaluru
Work from Office
Design statistical analysis plans for clinical trialsobservational studiesand laboratory experiments. Perform statistical analyses using appropriate software (egSASRPython). Collaborate with clinical researchersdata managersand regulatory teams to ensure data integrity and compliance. Interpret and communicate statistical results clearly to cross-functional teams and stakeholders. Prepare tableslistingsand figures for clinical study reports and publications. Support the preparation of documents for regulatory submissions (egFDAEMA). Stay current with advancements in biostatistics and relevant regulatory guidelines. Contribute to protocol developmentdata monitoringand interim analysis. Provide statistical consulting to internal teams on study design and methodology.
Posted 1 month ago
8.0 - 13.0 years
25 - 30 Lacs
Pune
Work from Office
About ProcDNA: ProcDNA is a global consulting firm. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. Were a passionate team of 200+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you wont be stuck in a cubicle - youll be out in the open water, shaping the future with brilliant minds. At ProcDNA, innovation isnt just encouraged, its ingrained in our DNA. What we are looking for: As the Sr. Engagement Lead, you ll leverage data to unravel complexities, adept at devising strategic solutions that deliver tangible results for our clients. We are seeking an individual who not only possesses the requisite expertise but also thrives in the dynamic landscape of a fast-paced global firm. What you ll do: Seeking an individual experienced in leveraging emerging technologies and best practices to address healthcare/pharma industry challenges. Collaborate with clients to model data and solve complex business issues. Analyze to aid strategic decision-making, utilizing tools like Tableau, SAS, R, and Alteryx Develop tailored healthcare analytics solutions to improve patient outcomes and cost management. Gain a comprehensive understanding of data and processes to deliver impactful outcomes. Work with clients to structure and model the data to solve complex business problems Develop and implement innovative solutions along with coaching, guiding, and mentoring Sr Analyst/ Associate Engagement Leads/ Engagement leads in the team. Must have: Candidates with a Bachelors degree in Engineering and 8+ years of strong analytics experience. Individuals with experience in statistical analysis, predictive modeling, Go-to-market strategy, segmentation, Forecasting, Sizing, Alignment, Marketing Mix Model, Targeting, and analyzing large datasets to derive insights and make data-driven decisions. Ability to work on and manage multiple projects for multiple stakeholders, with a quality mindset. Deep understanding of their Industry, including market trends, regulatory frameworks, and competitive landscapes. Excellent verbal and written communication skills, essential for effective collaboration. Proven ability to work creatively and analytically with minimal direction.
Posted 1 month ago
2.0 - 3.0 years
3 - 4 Lacs
Bengaluru
Work from Office
Key Responsibilities Design statistical analysis plans for clinical trialsobservational studiesand laboratory experiments. Perform statistical analyses using appropriate software (e.g.SASRPython). Collaborate with clinical researchersdata managersand regulatory teams to ensure data integrity and compliance. Interpret and communicate statistical results clearly to cross-functional teams and stakeholders. Prepare tableslistingsand figures for clinical study reports and publications. Support the preparation of documents for regulatory submissions (e.g.FDAEMA). Stay current with advancements in biostatistics and relevant regulatory guidelines. Contribute to protocol developmentdata monitoringand interim analysis. Provide statistical consulting to internal teams on study design and methodology.
Posted 1 month ago
10.0 - 15.0 years
20 - 25 Lacs
Kolkata, Mumbai, New Delhi
Work from Office
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.
Posted 2 months ago
6.0 - 10.0 years
8 - 12 Lacs
Mumbai
Work from Office
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:
Posted 2 months ago
9.0 - 13.0 years
25 - 30 Lacs
Bengaluru
Work from Office
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
Posted 2 months ago
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