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2.0 - 5.0 years
2 - 5 Lacs
Hyderabad / Secunderabad, Telangana, Telangana, India
On-site
In this vital role, you will collaborate with cross-functional teams across multiple time zones to fulfill programming requests, clarify requirements, escalate issues, and deliver high-quality results. As an Associate Biostatistical Programmer , you will be responsible for hands-on statistical programming, data manipulation, and report generation to support epidemiologists in generating Real-World Evidence (RWE) from large healthcare data assets. Key Responsibilities: Write, test, and validate programs in Unix and Databricks to produce datasets, tables, and figures for submissions, publications, and internal communications. Support programming activities aligned with departmental standards and timelines. Develop and execute macros and utilities at the protocol, product, or department level. Write, review, and approve analysis dataset specifications and programming plans . Troubleshoot and resolve programming issues; escalate when necessary. Participate in audit activities and respond to audit findings (internal and external). Represent the programming function in multidisciplinary team meetings . Contribute to technical process improvements and programming innovations. Engage with professional networks through conferences , workshops , and internal knowledge sharing . Collaborate globally across teams to implement analyses from Statistical Analysis Plans (SAPs). Required Qualifications: Bachelor's degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics, or a related field with 03 years of experience OR Diploma in a relevant field with 47 years of experience Proficiency in SAS and SQL Experience in a clinical development , life sciences , or healthcare data setting Preferred Qualifications: Programming experience in R and/or Python Familiarity with OMOP common data model Experience working with real-world healthcare data (RWD) such as: Insurance claims databases: MarketScan, Optum Clinformatics, Medicare Electronic Health Records (EHR): Flatiron, Optum EHR, CPRD, MDV, PanTher Exposure to Databricks , Unix , and large data processing systems Core Competencies & Soft Skills: Strong individual contributor with the ability to troubleshoot and solve complex problems Excellent verbal and written communication in English High attention to detail and documentation accuracy Effective team collaboration across global time zones Strong scientific and technical aptitude Willingness to learn and adapt in a fast-paced R&D environment Demonstrated ability in leadership, innovation, and continuous improvement Technical Skills Summary: Required: SAS, SQL Preferred: R, Python Platforms: Unix, Databricks Data Models: OMOP (preferred) Real-World Data Experience: MarketScan, Optum Clinformatics, Flatiron, CPRD, MDV
Posted 2 months ago
5.0 - 9.0 years
6 - 9 Lacs
Hyderabad
Work from Office
What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for manipulating large databases and generating reports to partner with epidemiologists to explore and generate RWE from real-world healthcare data assets. The ideal candidate should possess a bachelor’s degree and have at least six years of relevant career experience in statistical programming. Proficiency in SQL programming and SAS or R programming is required. The successful candidate will demonstrate scientific and technical excellence, exceptional oral and written communication skills, problem-solving abilities, and meticulous attention to detail. The ability to work effectively within a large, globally distributed team is essential. Responsibilities: Provide technical solutions to programming problems within CfOR(Centre for Observational research). Lead and develop technical programming and process improvement initiatives within CfOR Represent the programming function and participate in multidisciplinary project team meetings Project manage programming activities, according to agreed resource and timeline plans Ensure programming activities adhere to departmental standards and SOPs Write and/or review and approve programming plans Write and/or review and approve analysis dataset specifications Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc. Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications Write, test, validate and execute department-, product- and protocol-level macros and utilities Oversee the work of outsourced resources assigned to projects Lead and/or participate in the development and review of CfOR policies, SOPs and other controlled documents Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings Participate in the recruitment of programming staff Actively participate in external professional organizations, conferences and/or meetings Provide input to and participate in intra-departmental and CfOR meetings Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D) Manage staff performance and oversee staff assignments and utilization Relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR Bachelor’s degree and 6 to 8 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR Diploma and 10 to 12 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience Preferred Qualifications: Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in statistical programming projects Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model. Experience: Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials Team management Global collaboration Request fulfillment oversight, clarifying requirements, project tracking, project fulfillment, statistical programming, issue resolution, expert resource, results delivery Statistical programmingSQL required; SAS or R required; Python preferred Experience working with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV) Key Competencies Hands-on programming and lead role Expert statistical programming knowledge using SAS or R RequiredSAS or R RequiredSQL PreferredPython Excellent verbal and written communication skills in English Ability to have efficient exchanges with colleagues across geographical locations Agile project management Real-world data (RWD) including insurance claims databases, electronic medical records and patient registries; for example, MarketScan, Optum, PharMetrics, Flatiron, Medicare OMOP common data model Drug development life cycle Statistics and basic epidemiologyIncidence and prevalence [Required for Regulatory RWE role]CDISC (SDTM, ADaM) Scientific / technical excellence Oral and written communication, documentation skills Leadership Innovation Teamwork Problem solving Attention to detail 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 for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com
Posted 2 months ago
2.0 - 7.0 years
9 - 10 Lacs
Pune, Chennai, Coimbatore
Work from Office
Description Statistical Programmer - L2 Job Summary: Statistical Programmer reports to Principal Statistical programmer 3/ Lead, Statistical Programming (L4 (3) or M1) , is responsible to work independently on the most of the Mapping activities (SDTM/Client specific mappings) which are simple and medium complex for assigned client in the given environment for the standard domains. Understanding clinical domain, mapping logic, data issues is a part of this role. Learning the product/system/mechanism to be used for SDTM mapping is a part of this role. Knowledge, Skills & Abilities: Clinical Domain knowledge Familiarity with CDISC Standards (SDTM Knowledge, ADaM , Submission package) SAS Programming (Experience up to 2 years) Python Programming will be an added advantage R Programming will be an added advantage Good Communication skills, learning attitude and good team player Education and Work Experience: Graduation in Pharmacy/Computer Science, or any such equivalent graduation from a reputed institute. Total experience is between 2 - 4 years Responsibilities: Ability to pick up multiple tools/technologies on the job. Import and Export raw data Contribute to Mapping specifications Utilize SAS/R programming/Python programming skills for clinical trial study submissions Develop programs identifying data issues and reporting them to the appropriate team Utilize appropriate guidelines to build CDISC/regulatory compliant datasets Understand CRF annotations and check for consistency with raw data Ability to debug custom functions/SAS Macros and fix issues Good understanding of clinical data and domain Follow Client Processes and SOPs Assist senior team members in quality control processes Assist senior team members with team metrics Communicate with an internal team to create deliverables for pharmaceutical and CRO clients Work in tandem with Biostatistics and Data Management members on clinical projects Communicate with programming and statistics leads Make sure you are compliant with company policies/SOPs. About US: Saama automates key clinical development and commercialization processes, with artificial intelligence (AI), Generative AI and advanced-analytics, accelerating your time to market. We offer AI-backed SaaS solutions as well as product-based industry services and accelerators. Discover more at saama.com.
Posted 2 months ago
4.0 - 8.0 years
9 - 15 Lacs
Hyderabad, Pune, Bengaluru
Work from Office
Hi, We are hiring for the ITES Company for the Clinical SAS + SQL Programmer Profile. Job Description: Minimum 4 years of experience in any CDMS application. To perform a wide range of Clinical Data Management activities resulting in high quality database within stipulated timelines. To provide expertise in programming concepts to the Data Management team Must be able to develop the connection with the stake holders by pro-actively communicating over the calls and handling the queries by resolving them on the spot or later depending on the nature of the problem. Must be able to contribute the solutions to the DMs or Medical scientist for their New requirements either programmatically or convincing them with the technical limitations, if any, along with providing alternative solution. Must have capability to develop new Macros in SAS or modify any SAS Macros that are used globally throughout studies as a part of automation. Preferred Skills: Excellent interpersonal and communication skills Capability to lead by motivation and exle. Strong knowledge in SAS macros is required. General knowledge of Clinical Trials and Pharmaceutical Industry Oracle/PL SQL, CDMS like SAS, Inform etc Key Skills: a) Minimum 4 years of experience in any Clinical Data Management application. b) Should have Oracle/PL SQL, CDMS like SAS, Inform etc c) Any Medical Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Pune ) Type : Job Code # 483 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 484 b) To Apply for above Job Role ( Hyderabad ) Type : Job Code # 485
Posted 2 months ago
2.0 - 5.0 years
15 - 20 Lacs
Nagpur, Bengaluru
Work from Office
Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 years of experience for Senior Statistical programming is a mandate. • Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. • Associate should be able to manage communication with customers, track and ensure quality on-time deliverables • Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. • Experience in SDTM, ADAM & TLF • Experience in EDC & VEEVA • Expertise in Base and Advance SAS programming. • Expertise in developing macros and developing generalized programs. • Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. • Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. • Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) Any Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Bangalore ) Type : Job Code # 91 b) To Apply for above Job Role ( Nagpur ) Type : Job Code # 92
Posted 2 months ago
7.0 - 12.0 years
15 - 20 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are Hiring for the ITES Company for the position of SAS: Statistical Programmer Job Description: We are looking for an associate with at least 5 - 10 years of experience for Statistical programming position, having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables, suggest and drive implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. SAS Developer with over 5+ years of experience with expertise on different domains. Possess solid ability in integrating programming skills, adapting to new applications and expertise in architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. Experience in ETL Preparation, data exploration, data preparation, data cleansing, reporting, and technical document preparation. Import /Export data using various techniques like PROC IMPORT, PROC EXPORT, LIBNAME, INFILE, PROC PRINT statements. Good Knowledge of Data management, Data handling, and Creating Data structure Knowledge of Database languages such as MYSQL, Oracle. Knowledge of various SAS Procedures like PROC Means, PROC Freq, PROC Contents, PROC Import, PROC Format, Proc Summary, PROC Sort, PROC Transpose, and PROC Report. Knowledge Of SAS procedures like SAS/Base, SAS/Macro, SAS/SQL, SAS Arrays, Do loops, SQL Joins, Hash join techniques To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 208 b) To Apply for above Job Role ( Pune ) Type : Job Code # 209
Posted 2 months ago
5.0 - 10.0 years
10 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi , We are hiring for Leading ITES Company for SDTM Programmer Profile. Please go through the JD and we will get back to the relevant profiles. Job Description: Minimum 3 years of experience for Senior Statistical programming is a mandate. Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Experience in SDTM, ADAM & TLF Experience in EDC & VEEVA Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 208 b) To Apply for above Job Role ( Pune ) Type : Job Code # 209
Posted 2 months ago
5.0 - 8.0 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 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 291 b) To Apply for above Job Role ( Pune ) Type : Job Code # 292
Posted 2 months ago
3.0 - 7.0 years
5 - 9 Lacs
Pune
Work from Office
The Statistical Programmer (SP) within the Ergomed Biostatistics (BS) department is responsible for the creation of SDTM/ADaM datasets and programming tables, listings and figures or other types of output, supporting and complimenting the biostatistician(s) of a project and creating and maintaining appropriate documentation. The Statistical Programmer is accountable for the first-time quality of the product, either dataset or output, via thorough QC steps. Role and Responsibilities Maintains responsibility for all assigned duties within a clinical study, this may include: Ensuring that work is performed on time Ensuring all content created/reviewed is appropriate, valid, and relevant to the study and of high quality Works with other biometrics team members to represent the needs and input of the programming components of the study Program SDTM and ADaM datasets Create SDTM and ADaM specifications Create CDISC submission packages e.g. Define.xml and Reviewers Guide Program tables, listings, and figures in SAS from specifications Deliver training and mentorship to SP and other operational staff, as applicable Contribute to the development of the department in supporting adherence to good programming and best practices by contributing to training, development of macros and standard processes, input and/or review of controlled documents, or other related content Act as a statistical programming expert and provide consultative support to internal programmers and biostatisticians with any programming related topics Act as a program or sponsor lead across multiple studies, clinical programs, and/or large complex studies with responsibility for all statistical programming activities and ensuring consistency across multiple studies Develop innovative techniques to solve complex programming problems on a clinical study or program of clinical studies to increase efficiency Assist their manager with programming work projections to aid departmental planning Represent statistical programming in client or agency study audits Supports the Head of Biostatistics, or Manager/Director, Statistical Programming on topics related to programming issues, process improvement, industry trends, and other relevant topics Excellent knowledge and understanding of SAS Base, Macro and ODS Education Bachelors Degree, preferably in Computer Science, Mathematics/Statistics, or a quantitative natural science. Thorough knowledge of SAS programming and statistical programming topics
Posted 2 months ago
3.0 - 7.0 years
5 - 9 Lacs
Pune
Work from Office
The Statistical Programmer (SP) within the Ergomed Biostatistics (BS) department is responsible for the creation of SDTM/ADaM datasets and programming tables, listings and figures or other types of output, supporting and complimenting the biostatistician(s) of a project and creating and maintaining appropriate documentation. The Statistical Programmer is accountable for the first-time quality of the product, either dataset or output, via thorough QC steps. Role and Responsibilities Maintains responsibility for all assigned duties within a clinical study, this may include: Ensuring that work is performed on time Ensuring all content created/reviewed is appropriate, valid, and relevant to the study and of high quality Works with other biometrics team members to represent the needs and input of the programming components of the study Program SDTM and ADaM datasets Create SDTM and ADaM specifications Create CDISC submission packages e. g. Define. xml and Reviewers Guide Program tables, listings, and figures in SAS from specifications Deliver training and mentorship to SP and other operational staff, as applicable Contribute to the development of the department in supporting adherence to good programming and best practices by contributing to training, development of macros and standard processes, input and/or review of controlled documents, or other related content Act as a statistical programming expert and provide consultative support to internal programmers and biostatisticians with any programming related topics Act as a program or sponsor lead across multiple studies, clinical programs, and/or large complex studies with responsibility for all statistical programming activities and ensuring consistency across multiple studies Develop innovative techniques to solve complex programming problems on a clinical study or program of clinical studies to increase efficiency Assist their manager with programming work projections to aid departmental planning Represent statistical programming in client or agency study audits Supports the Head of Biostatistics, or Manager/Director, Statistical Programming on topics related to programming issues, process improvement, industry trends, and other relevant topics Excellent knowledge and understanding of SAS Base, Macro and ODS
Posted 2 months ago
7.0 - 12.0 years
9 - 19 Lacs
Mumbai, Hyderabad, Bengaluru
Work from Office
Strong experience in Statistical Programming(SDTM, ADAM, TLF )in clinical domain using R (must required) and SAS. Data analysis, visualization and advanced statistical modeling using R and SAS will be an added advantage. Should have experience in programming SDTM, ADAM, TLF in the clinical domain. Develop, validate, and implement statistical models using SAS and R. Analyze large datasets to identify trends, patterns, and insights. Design and generate reports and dashboards for various stakeholders. Automate data processing tasks using SAS macros and R scripts. Collaborate with cross-functional teams to understand data needs and deliver actionable insights. Ensure data quality and integrity through rigorous testing and validation. Provide recommendations based on data analysis to support strategic decisions Excellent analytical, problem-solving, and communication skills. Ability to manage multiple tasks and projects with a high attention to detail.
Posted 2 months ago
3.0 - 7.0 years
5 - 9 Lacs
Chennai
Work from Office
Job Description: SENIOR SAS PROGRAMMER The Senior SAS programmer leads the programming activities for various purposes including CSRs, DSMBs, interim analyses, manuscripts, etc. Mainly supports statistical programming of statistical analysis plan (SAP)-planned tables, data listings, and graphs for CSRs, as well as integrated summaries of safety and efficacy, ad hoc analyses and electronic submission deliverables, such as datasets, data documentation, programs, programming table of contents, and patient profiles. In addition, the Senior SAS Programmer supports migration activities in the creation of Standard Data Tabulation Model (SDTM) and production of the Analysis Data Model (ADaM). The Senior SAS Programmer is also responsible for monitoring and meeting assigned program milestones and will lead a team of programmers to accomplish tasks. VERISTAT INFO For more than 30 years, Veristat has built a reputation as global experts in clinical development, registration, and post-marketing solutions. We have done so by hiring talented people whose core values are aligned with ours and who share a common passion for our mission driven work. We do things differently than other CROs and would love to have you join our Veristat team! Experience & Minimum Requirements Bachelor s Degree in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 8 years of SAS programming experience with clinical trial data OR Master s Degree in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 6 years of SAS programming experience with clinical trial data. Good working knowledge of CDISC SDTM and ADaM Implementation Guidelines. General knowledge of regulatory requirements and drug development process. Excellent organizational skills and good verbal and written communication skills. Ability to work independently as well as lead programming teams. Strong communication skill set with peers, business partners, and Sponsors. Strong Analytical mindset. Leadership skills to lead project team to deliver high quality deliverables on time and work directly with the Sponsor to meet the project delivery expectations. Must be fluent in English (written and verbal).
Posted 2 months ago
4.0 - 9.0 years
15 - 17 Lacs
Hyderabad
Work from Office
Our Team: Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: The Senior Statistical Programmer will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans and provide QC d data packages including tables, figures, and listings for use in publications (i.e. abstracts, posters, oral, presentations, manuscripts and ad-hoc data analysis requests) ;The Senior Statistical Programmer will develop, implement, and document non-routine macros and advanced techniques; The Senior Statistical Programmer will ensure SOPs are followed and timelines and quality are met. People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and/or programming team members within the allocated Global business unit and product - with an objective to develop statistical data outputs. Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data and/or registry. 2) Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS. 3) Produce well documented data packages that include tables, listings, and figures. 4) Remain current on advanced programming methods Customer: 1) Work closely with Global Medical Affairs biostatisticians and/or programmers to identify statistical analysis needs and assist in developing assigned deliverables About you Experience : Masters degree minimum 4 years/B.Sc. minimum 6 years of relevant experience required Soft skills : Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment Technical skills : Advance SAS programming skills, SDTM & ADaM (CDISC) Education : Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field. Languages : Excellent English language knowledge - written and spoken
Posted 2 months ago
2.0 - 5.0 years
10 - 14 Lacs
Hyderabad
Work from Office
Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together Primary Responsibilities Collaborate closely with the data science, business, and strategy teams on one or more DS/ML projects throughout the engagement lifecycle, from design to implementation Demonstrate a solid sense of project ownership Ensure timely and effective communication with business partners and leaders Deliver engagements promptly and with high quality, requiring minimal supervision Partner with business teams to operationalize analytics solutions Communicate with business partners on all critical project functions, including data understanding and solution design Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so Required Qualifications Master’s degree in Computer Science, Engineering, Statistics, or a related field preferred 5+ years of experience working with large-scale data/ML pipelines and their supporting infrastructure Experience with Natural Language Processing (NLP) and Large Language Models (LLMs) Experience deploying ML solutions on cloud platforms, preferably AWS (AWS services such as SageMaker, Bedrock, Glue) Experience building LLM models using the RAG framework and AI Agents, and deploying LLM applications in production Solid background in machine learning and statistics Solid foundation in data structures and algorithms Proficient software engineering skills Proficiency in Python for numerical and statistical programming (experience with Pandas, NumPy, Scikit-learn, PyTorch is essential) Ability to write complex SQL queries Knowledge of A/B test design and analysis Proven track record of leading the deployment and maintenance of models Proven excellent interpersonal and teamwork skills Solid written and verbal communication skills Proven exceptional problem-solving abilities Professional, service-oriented, proactive, and flexible mindset At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone - of every race, gender, sexuality, age, location and income - deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.
Posted 2 months ago
4.0 - 9.0 years
20 - 25 Lacs
Bengaluru
Work from Office
Key Responsibilities This position is for an Associate Director (WRB) with experience in areas of Credit Risk Scorecards and Credit Risk Strategy (cut-off analysis, line assignment et. al) for retail banking / small business lending businesses. The individual will drive delivery (2-3 engagements at any given time) of both Credit Risk Scorecards and associated Credit Risk Strategies (as well as other risk analytics) for all Retail and SME portfolios of Standard Chartered Bank. The individual is expected to be hands-on at all times. Responsibilities include understanding Standard Chartered Group requirements and working with the team in developing statistically derived predictive models, performing decision tree-based customer segmentation and profiling analyses, assisting business implementation of sophisticated risk models and providing analytic support to Standard Chartered Businesses across the globe. The individual is expected to drive timely delivery with assigned resources on an engagement, while ensuring compliance to prevailing / applicable standards / legislation / policies Strategy Strategic mindset Business Retail Business Understanding Processes Process improvement People Talent People manager Lead through example. Set clear expectations from the teams and work in collaboration with all relevant partners. Set and monitor objectives for team members and provide feedback Risk Management Manages risk Governance Adhere to governance Key stakeholders Unsecured and Secured Risk and Business Heads of Countries Head of Scorecards Group Model Validation Model Risk Policy and Governance Model Delivery Management Skills and Experience Leading and owning 1-2 engagements at any given time Ability to explain modelling outputs and inferences to Senior Stakeholder in non-technical manner Need of getting involved in on-the-ground and data activities Analytical / Strategic / Conceptual thinking Attention to detail Problem solving Highly motivated, organized and methodical Qualifications Bachelors / Advanced (Masters or higher) degree in Statistics, Applied Mathematics, Operations Research, Economics, Engineering, MBA or other quantitative discipline At least 4 years of total experience in a retail banking / small business lending analytical function. Hands-on experience of 4 - 6 years, in the past in statistical modeling, mining data and understanding data patterns is an absolute necessary to lead engagements. Past exposure to statistical programming skills in SAS (preferred) or similar tools Experience in directly interacting with Business and exposure to international markets will be a plus Together we: Do the right thing and are assertive, challenge one another, and live with integrity, while putting the client at the heart of what we do Never settle, continuously striving to improve and innovate, keeping things simple and learning from doing well, and not so well Are better together, we can be ourselves, be inclusive, see more good in others, and work collectively to build for the long term In line with our Fair Pay Charter, we offer a competitive salary and benefits to support your mental, physical, financial and social wellbeing. Core bank funding for retirement savings, medical and life insurance, with flexible and voluntary benefits available in some locations. Time-off including annual leave, parental/maternity (20 weeks), sabbatical (12 months maximum) and volunteering leave (3 days), along with minimum global standards for annual and public holiday, which is combined to 30 days minimum. Flexible working options based around home and office locations, with flexible working patterns. Proactive wellbeing support through Unmind, a market-leading digital wellbeing platform, development courses for resilience and other human skills, global Employee Assistance Programme, sick leave, mental health first-aiders and all sorts of self-help toolkits A continuous learning culture to support your growth, with opportunities to reskill and upskill and access to physical, virtual and digital learning. Being part of an inclusive and values driven organisation, one that embraces and celebrates our unique diversity, across our teams, business functions and geographies - everyone feels respected and can realise their full potential. 29834
Posted 2 months ago
5.0 - 10.0 years
7 - 12 Lacs
Noida, Hyderabad
Work from Office
Job Details Job Summary: We are seeking a highly skilled Clinical Statistician with extensive experience in CDISC-compliant statistical programming. The ideal candidate will be responsible for providing statistical support for individual clinical trials as well as integrated summaries of safety (ISS) and efficacy (ISE). This role requires a deep understanding of clinical trial design, data analysis, and regulatory requirements. Key Responsibilities: Develop and execute statistical analysis plans for clinical trials. Perform statistical programming using SAS and R, ensuring compliance with CDISC standards. Conduct integrated analyses for ISS and ISE, ensuring consistency and accuracy across studies. Leverage experience (if applicable) to support the preparation of datasets and documentation for regulatory submissions, such as ISS/ISE, in line with global standards (e.g., FDA, EMA) Generate tables, listings, and figures (TLFs) for clinical study reports (CSRs) and regulatory submissions. Collaborate with cross-functional teams, including clinical research, data management, and medical writers, to ensure accurate and timely delivery of statistical outputs. Provide statistical input for study design, protocol development, and sample size calculations. Review and validate statistical deliverables to ensure quality and compliance with regulatory guidelines. Stay current with industry trends and advancements in statistical methodologies. Contribute to process optimization and development of templates, or standardized processes to enhance team efficiency and consistency. Qualifications: Masters or Ph.D. in Statistics, Biostatistics, or a related field. Minimum of 5 years of experience in clinical statistics, with a focus on CDISC-compliant statistical programming. Proficiency in SAS and R programming, in aim of increasing efficiency. Experience with integrated summaries of safety (ISS) and efficacy (ISE). Strong understanding of clinical trial design, data analysis, and regulatory requirements. Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills, with the ability to guide diverse groups of people through complex processes in a team environment. Ability to manage multiple projects and meet deadlines in a fast-paced environment. . Preferred Qualifications: Experience in the pharmaceutical or biotechnology industry. Knowledge of other programming languages (e.g., Python) is a plus. Familiarity with regulatory submission processes (e.g., FDA, EMA). Experience in management, Agile/scrum-type experience is a plus. Experience of working with international teams remotely is a plus. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex Belgium SA Equal Employment Opportunity Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Posted 2 months ago
5.0 - 10.0 years
25 - 30 Lacs
Mumbai
Work from Office
The Principal Statistical Programmer is responsible for all statistical programming aspects of a large/pivotal study, several studies or project-level activities (incl. submission activities). The position is a key collaborator with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high quality deliverables in Novartis Global Drug Development. Major accountabilities: 1. Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development. 2. Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level. 3. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), eg as member of the extended Clinical Trial Team (CTT). 4. Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT. 5. Comply with company, department and industry standards (eg CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans. 6. Provide and implement statistical programming solutions; ensure knowledge sharing. 7. In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets. 8. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications. 9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as we'll as accuracy and reliability of statistical analysis results. 10. Maintain up-to-date advanced knowledge of programming software (eg SAS) as we'll as industry requirements (eg CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. 11. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance 12. As assigned, act as subject matter expert (SME) or contribute to process improvement/nonclinical project initiatives with a focus on programming and analysis reporting procedures. Key Performance Indicators (Indicate how performance for this job will be measured) : Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers, including the Clinical Trial Team, Lead/Program Statistician and the functional/operational manager. Adequate representation of the Statistical Programming function as Trial/Lead/Program Programmer in the Clinical Trial Team(s). Effectiveness of communication and team behaviors as assessed by the team members. Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study/project as assessed by the functional/operational manager. Job Dimensions (Indicate key facts and figures) Number of associates: No direct reports. Coordination of 5+ internal and external programmers. Financial responsibility: (Budget, Cost, Sales, etc) None Impact on the organization: Timely, high quality and efficiently produced statistical programming deliverables included in study and project level documents (incl. submissions) Reliable and compliant statistical analysis results presented externally (incl. submissions) Innovative technical solutions to support timely and efficient drug development deliverables Ideal Background (State the preferred education and experience level) Education (minimum/desirable): BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Languages: Fluent English (oral and written). Experience/Professional requirement: Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications Good knowledge of industry standards including CDISC data structures as we'll as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (eg GCP, study procedures). Good communications and negotiation skills, ability to work we'll with others globally Experience as Trial Programmer, including coordination of internal or external programmers on a given study/project Ideally 5+years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry
Posted 2 months ago
4.0 - 9.0 years
32 - 40 Lacs
Bengaluru
Work from Office
Apply strategic and data analytics skills to solve problems for the PayPal Risk team. Work with stakeholders across different teams such as Product, Platform, Machine Learning, Operations to drive strategic initiatives. Meet our team: The Global Risk Automation Strategy (GRAS) team focuses on driving automation initiatives for the risk back office. We work closely with the Front end strategy, consumer and seller risk operations, product, and modeling teams to identify automation opportunities to drive efficiency. Job Description: As a Data Scientist, you will apply your strategic and analytical skills to solve challenging business problems. You will team up with world-class professionals to identify actionable insights that ultimately impact the bottom line of the company. We work in a space that looks deeply into emerging fraud trends to come up with analytical solutions to fight these fraud trends and we also work on business enablement opportunities that fuel growth and drive efficiencies within the organization Your day-to-day Provide analytical insights into problems, emerging trends and changes to portfolio Drive projects end to end from ideation to implementation in a time sensitive and efficient manner Identify new opportunities and continuous improvement to contribute to the team s KPIs and targets Case rating: Evaluate each lead and case for risk levels to determine the urgency, importance and need for manual reviews with a goal of Increasing case automation using various risk factors and exposure on a given account, additional profile or transactional information, adoption of Document Intelligence solution etc Ensure that we balance automation goals with loss. Partner with GADS and front end strategy team for agent decision and trend-based feedback model to improve automation quality. Work closely with business partners and stakeholders to determine how to design analysis and measurement approaches that will significantly improve our ability to understand and address emerging business issues Effectively managing relevant stakeholders through the lifecycle of a project by effectively understanding the various needs, priorities and perspectives in order to drive for a solution Understand new products, features and trends and their impact to back office reviews. Identifying present or future gaps in the team s existing reporting and tools suite Providing regular updates to leadership, product and other stakeholders that will simplify and clarify complex concepts and the results of analyses effectively with emphasis on the actionable outcomes and impact to business What do you need to bring Solid technical / data-mining skills and ability to work with large volumes of data; extract and manipulate large datasets using common tools such as SQL, SAS, Hadoop, or other programming/scripting languages (Python, R, etc) to translate data into business decisions/results Be data-driven and outcome-focused Must have good business judgment with demonstrated ability to think creatively and strategically Must be an intuitive, organized analytical thinker, with the ability to perform detailed analysis Takes personal ownership; Self-starter; Ability to drive projects with minimal guidance and focus on high impact work Bachelors Degree in a quantitative discipline (Economics, Engineering, Computer Science, Math, Statistics) 4+ years experience in analytics Proficiency using SQL and querying relational databases Experience in at least one statistical programming language (SAS, R, Python) Experience in predictive modelling techniques such as Regression, Classification, Time series forecasting, NLP, etc Experience with structuring analyses to solve business problems using data and analytics tools and techniques Experience with project/program management Experience in Fintech/Banking/Credit/Payment industry a strong plus
Posted 2 months ago
10.0 - 15.0 years
45 - 50 Lacs
Mumbai
Work from Office
Provide highly advanced expert support functional and technical leadership to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Develops and applies biostatistics and programming methods to ensure valid conclusions. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other RD areas. To meet challenges in data review, big data, analytics and reporting of clinical trial data may also Independently provide timely and professional leadership of special projects that focus on innovative tools and systems -Strategically and tactically supports Director Clinical Data Standards. Responsible for advising/leading the planning, development and implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. May lead global teams Key Responsibilities Study Level- Responsible for all statistical tasks on assigned clinical or non-clinical trials, and perform these tasks for high complexity trials with a high level of independence seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, and reporting activities. Contribute to planning and execution of exploratory analyses, innovative analyses related to publications and pricing reimbursement submission and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs and dose-finding strategies in alignment with the Lead Statistician. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities, pricing agencies and other drug development activities, as required. Independently lead interactions with external review boards/ethics commit-tees, external consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications and interpretation of analysis results for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the clinical trial team and Biostatistics Pharmacometrics team. Independent oversight of all Biostatistics resources and deliverables for as-signed trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project Level- Responsible for strategic statistical input and influence into one or more projects (development plan, regulatory strategy, publication strategy, pricing reimbursement strategy, statistical deliverables). May be a core member of one or more early project teams representing Bio-statistics and Pharmacometrics. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful im-pact on robust drug development plans. Collaborate cross-functionally (eg, with data management, statistical programming, medical writing) to ensure timeliness and quality of statistical deliverables. Facilitate seamless transition of projects from early to late development. Effective partnership with other functions to ensure integrated quantitative in-put into project. Propose and implement innovative designs and methods to optimize drug development. Plan, prioritize and oversee project level statistical activities and ensure efficient resource management and effective partnership with vendors. Drive adherence to organizational standards and regulatory guidelines. Represent Biostatistics and Pharmacometrics at internal and external decision boards (eg regulators) Significantly contributes to project team preparation and may play a prominent role representing Biostatistics at HA meetings. Disease Area / TA/Indication level: As partner to clinical and scientific leadership, drive strategic statistical input and excellence to development programs within the assigned TA/DA/indications. Franchise or Global Line Function level: Lead or significantly contribute to initiatives at global line function level, or cross-functional Franchise level, requiring coordination of diverse of team members. May contribute to line function review. Enterprise level: Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Represent Biostatistics in due-diligence teams for low- to mid-complexity in-licensing opportunities with supervision. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and outside the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewe'd journals, presentations and chairing sessions at professional meetings. External: Represent Biostatistics and Pharmacometrics in interactions with external re-view boards/ethics committees, external consultants and other external parties with increasing independence. Chair sessions at professional meetings. People Management: Develop and mentor statisticians. As a local manager, responsible to recruit, retain and professionally develop up to 8 biostatisticians. Role Requirements- MS (in Statistics or equivalent) with 10+ years relevant work experience or PhD (in Statistics or equivalent) with 6+ years relevant work experience Fluent English (oral and written) Strong interpersonal and communication skills bridging scientific and business needs. Effective utilization of innovative statistics and quantitative analytics to influence assigned program team decisions and support department to deliver objectives. Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Demonstrated excellence in use of statistical software packages (eg SAS, R). Strong knowledge of drug development and Health Authority guidelines. Experience independently leading a multidisciplinary team to achieve team objectives. Expert skills to facilitate and maximize the contribution of quantitative team. Hands-on experience in leading the interface to regulatory agencies/leading the early clinical development campaign. Strong understanding of Franchise/Therapeutic Area and or regulatory activities. Expert scientific leadership skills demonstrated in facilitating and optimizing the (pre/early/full-) clinical development strategy. Strong track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies. May have proven people leadership ability. Demonstrated strong skills in building partnerships and collaborations. Demonstrated skills in coaching and mentoring associates. Good business ethics
Posted 2 months ago
8.0 - 13.0 years
12 - 16 Lacs
Hyderabad
Work from Office
The Principal Real World Evidence (RWE) Research Analyst is responsible for the scientific and methodological aspects of all RWE projects as we'll as providing guidance for other team members. Key Responsibilities: Produce analytic results including full study reports for RWE or observational database analyses projects. Independently draft and edit documents such as high level research proposals, protocols and statistical analysis plans. Develop project timelines together with the Real World Evidence Data Scientists. Appropriately supervise communications with the customer as we'll as project related decisions taken. Conduct observational data analyses involving new creative approaches and supervise data management and statistical programming activities. Handle the outsourcing of programming activities from Data Science to an approved vendor in accordance with Scientific Services vendor management procedures. Provide guidance to conduct data quality reviews with detailed documentation. Present research and analysis results to customers and partners. Collaborate with RWE Center of Excellence (CoE) to drive quality and accuracy of results; constant improvements on systems, processes and quality matrices that contribute to existing solutions. Produce analysis datasets, listings, tables, and figures for research projects, according to specifications, while maintaining documentation and aligning with pre-defined project / study standards. Perform in-depth research and quantitative and qualitative analysis independently. Provide guidance to Associate Rwe'research Analysts and Rwe'research Analysts. Seek out opportunities for the development of new RWE services and new customers within Novartis. Maintain familiarity with technical developments in RWE, epidemiological and data science fields. Commitment to Diversity Inclusion: : Essential Requirements: Graduation degree with 8+ years conducting research in the pharma industry, contract research organization, or academic institute; or experience in a closely related field within the pharma industry (eg, clinical research, statistics, epidemiology, pricing). masters degree in a field such as epidemiology, biostatistics, statistics, bioinformatics, economics or similar. And 5+ years of proven experience conducting research in the pharma industry, contract research organization, or academic institute; or experience in a closely related field within the pharma industry. Experience in the application of statistical methods to the analysis of observational data. Technical proficiency in analytical and visualization tools and statistical programming languages such as SAS, R, R/shiny, Tableau, Spotfire, SPSS, STATA, WinBUGs. Deep knowledge of Rwe'data sources and standards such as MarketScan, CPRD, JMDC, Optum, PharMetrics, OMOP. Expert in applied statistics. Extensive experience in the application of statistical methods for analysis of observational data including propensity scores, sensitivity analyses, etc is a plus. Good understanding of organizational processes. Extensive experience working cross-functionally with key internal partners. Open to experimentation and doing things differently to support creative thinking that leads to practical solutions to healthcare and business challenges. Holds a high standard on quality excellence. Continuously seeking to enhancing standards, technology through expansion of knowledge and training. Support partnership to swiftly and efficiently deliver innovative new products to patients and healthcare providers. High ethical values and standards. Able to speak out, challenge conventional thinking, and stand up for ideas. Experienced in data visualization Desirable Requirements: Ability to work, prioritize, and drive projects independently. Ability to handle multiple projects and partners.
Posted 2 months ago
5.0 - 10.0 years
7 - 11 Lacs
Noida, Hyderabad
Work from Office
We are seeking a highly skilled Clinical Statistician with extensive experience in CDISC-compliant statistical programming. The ideal candidate will be responsible for providing statistical support for individual clinical trials as we'll as integrated summaries of safety (ISS) and efficacy (ISE). This role requires a deep understanding of clinical trial design, data analysis, and regulatory requirements. Key Responsibilities: Develop and execute statistical analysis plans for clinical trials. Perform statistical programming using SAS and R, ensuring compliance with CDISC standards. Conduct integrated analyses for ISS and ISE, ensuring consistency and accuracy across studies. Leverage experience (if applicable) to support the preparation of datasets and documentation for regulatory submissions, such as ISS/ISE, in line with global standards (eg, FDA, EMA) Generate tables, listings, and figures (TLFs) for clinical study reports (CSRs) and regulatory submissions. Collaborate with cross-functional teams, including clinical research, data management, and medical writers, to ensure accurate and timely delivery of statistical outputs. Provide statistical input for study design, protocol development, and sample size calculations. Review and validate statistical deliverables to ensure quality and compliance with regulatory guidelines. Stay current with industry trends and advancements in statistical methodologies. Contribute to process optimization and development of templates, or standardized processes to enhance team efficiency and consistency. Qualifications: Masters or Ph.D. in Statistics, Biostatistics, or a related field. Minimum of 5 years of experience in clinical statistics, with a focus on CDISC-compliant statistical programming. Proficiency in SAS and R programming, in aim of increasing efficiency. Experience with integrated summaries of safety (ISS) and efficacy (ISE). Strong understanding of clinical trial design, data analysis, and regulatory requirements. Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills, with the ability to guide diverse groups of people through complex processes in a team environment. Ability to manage multiple projects and meet deadlines in a fast-paced environment. Preferred Qualifications: Experience in the pharmaceutical or biotechnology industry. Knowledge of other programming languages (eg, Python) is a plus. Familiarity with regulatory submission processes (eg, FDA, EMA). Experience in management, Agile/scrum-type experience is a plus. Experience of working with international teams remotely is a plus.
Posted 2 months ago
4.0 - 9.0 years
17 - 19 Lacs
Hyderabad
Work from Office
-Responsible for all statistical programming/data review reporting and analytics development aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Complies with project / study standards and specifications following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting compliance with timelines. About the Role Major accountabilities: Lead statistical programming activities for several studies or drive the implementation of data analytics reports -Make decisions and propose strategies at study or project level. May act as functional manager for local associates including providing supervision and advice on functional expertise and processes. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical aspects (timelines, scope, resource plan), eg as representative in study or project-level team. Ensure project-level standardization -Provide and implement programming solutions; ensure knowledge sharing. Act as expert in problem-solving aspects. Ensure timely and quality development and validation of datasets and outputs for regulatory submissions/interactions, safety reports, publications, post-marketing activities etc -Leads/co leads novel projects within the team -Generates innovative ideas within own team and /or project team /functional community -Recognizes and leverages innovation opportunities for own team across projects -Mentors and inspires others to solve problems -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across functional activities and deliverables. Adherence to Novartis policy and guidelines -Customer / partner feedback and satisfaction Minimum Requirements: Work Experience: Biostatistics. Clinical Research Phases. RD Portfolio Management. Statistical Programming. Data Management Systems. Regulatory Submissions. Innovative Analytical Technologies. Clinical Trial Design, Data Review Reporting. Skills: Classification Systems. Clinical Trials. Computer Data Storage. Computer Programming. Cross-Functional Teams. Data Analysis. Data Structures. Initiative. Programming Languages. Reporting. Statistical Analysis. Languages : English.
Posted 2 months ago
6.0 - 12.0 years
6 - 12 Lacs
Chennai, Tamil Nadu, India
On-site
Perform statistical programming review of casereport forms (CRFs), annotated CRFs, database structures, statistical analysisplan (SAP) project documentation such as Statistical Analysis Plan (SAP), mockshells, programming specifications and annotated CRFs Provide the statistical programming support forassigned studies, in both production and QC of analysis dataset specifications,analysis datasets, statistical analysis tables, data listings, figures, andstatistical appendices Provide the status of assigned tasks to StudyLead Programmer and Project Manager Identify, communicate, and manage study-basedrisks and issues Maintain supporting documentation for studies inaccordance with SOPs, Work Instructions (WI) to ensure traceability andregulatory compliance Contribute to development of StatisticalProgramming standards and processes to improve quality, efficiency, andeffectiveness Ensure audit readiness and quality control forall assigned statistical programming deliverables as well as accuracy andreliability of statistical analysis results Adhere learning and develop knowledge on thelatest in CDISC Therapeutic standards, GCP and applicable ICH guidelines
Posted 2 months ago
3.0 - 5.0 years
10 - 14 Lacs
Bengaluru
Work from Office
Acquire data from primary or secondary data sources and maintain databases /data systems Filter and clean data, blend data from multiple sources Interpret data, analyze results using statistical techniques and provide ongoing reports Work with management to prioritize business and information needs Locate and define new process improvement opportunities monitor and audit data quality Acquire insight from unstructured data set. Travel to cooling plant - Regularaly (Once a Week ) BTech (Mechanical ) Basic thermal Knowledge will be desirable . Skills Required Microsoft Excel Critical Thinking R or Python-Statistical Programming Data Visualization Presentation Skills Knowledge in usage of Structure / Unstructured data Bachelor Degree in Engineering ( Electrical / Mechanical)
Posted 2 months ago
2.0 - 7.0 years
11 - 16 Lacs
Hyderabad, Pune, Bengaluru
Work from Office
Perform comprehensive data management tasks, Validation, Data transfers and quality control procedures. Provide Clinical Data Management team with technical expertise. Perform tasks as communicated by TL/LDM Create/review the Data Management Plans Required Candidate profile Graduate/Postgraduate in Computer Science/Computer Application/Physics/Math/Life Sciences/Pharmacy 2-8 years of experience in Statistical (SAS) programming International BPO experience is mandatory
Posted 2 months ago
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