215 Biostatistics Jobs - Page 8

Description Principal Statistical Programmer Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. Transfers deliverables. Performs other work-related duties as assigned. Minimal travel may be required Qualifications What we’re looking for Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. Experience in mentoring others in clinical trial process and CDISC Standards. Excellent written and verbal communication skills. Ability to read, write, speak and understand English. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Job title : Real-World Evidence Data Scientist About The Job Our Team: Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions . Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, Globally. Main Responsibilities The overall purpose and main responsibilities are listed below: Provide a high level of expertise in employing cutting-edge analytical & computational approaches to drive evidence-based pharmaceutical product development; provide scientific and technical leadership in machine learning and AI; work closely with other disciplines across Sanofi including Business Units, Digital, R&D, Biostatistics, Information Technology Systems and other Data Science partners to deliver cutting edge analysis to key business questions. Examples of Advanced Analytics activities: (1) Machine/Deep Learning to elucidate disease trajectories, patient subtypes, define underdiagnosed conditions, and unmet health needs; (2) Create a framework for generating re-usable models and insights across big-data (e.g. EHRs, claims) and rich small data sets (e.g. clinical trials, imaging); (3) Generating insights by merging diverse data streams e.g. health, surveillance, trend data, sensor, imaging; (4) Adoption of emerging technology into an analytical framework: distributed analytics, graph databases People: (1) Act as a subject matter expert in machine learning, statistical and/or modelling working on team projects; (2) Work with internal and external study lead to execute Advance Analytics projects and studies. Performance: (1) Implement and execute computational and statistical methodologies in Advanced Analytics for RWE; (2) Provide expertise and execute advanced analytics for solving problems across R&D, Medical Affairs, HEVA and Market Access Strategies and Plans Process: (1) Apply a broad array of capabilities spanning machine learning, statistics, mathematics, modelling, simulation, text-mining/NLP, data-mining to extract insights and be able to communicate and champion these efforts across the company; (2) Plan and deploy methodological standards, standardized processes, demos, and POCs for the company’s highest priority business needs; (3) Contribute to the design, development, and implementation of Sanofi’s data science architecture and ecosystem to guide decision-making and building foundational capabilities About You Experience: Around 10 years’ experience; High level proficiency in at least two or more technical or analytical languages (R, Python, etc..); experience with advanced ML techniques (neural networks/deep learning, reinforcement learning, SVM, PCA, etc.); ability to interact with a variety of large-scale data structures e.g., HDFS, SQL, NoSQL; Experience working across multiple environments (e.g. AWS, GCP, Linux) for optimizing compute and big data handling requirements; Experience with any of the following: biomedical data types/population health data/real world data/novel data streams relevant to the pharmaceutical industry; Experience with big data analytics platforms or high-level ML libraries such as H2O, SageMaker, Databricks, Keras, pyTorch, TensorFlow, Theano, DSSTNE or similar; Ability to prototype analyses and algorithms in high-level languages embracing reproducible and collaborative technology platforms (e.g. GitHub, containers, jupyter notebooks); Exposure to NLP technologies and analyses; Knowledge of some datavis technologies (ggplot2, shiny, plotly, d3, Tableau or Spotfire); Experience with probabilistic and/or functional programming languages such as Stan, Edward, Scala; Experience with advanced ML techniques (RNN, CNN, LSTM, GRU, Genetic Algorithms, Reinforcement Learning, etc.) Real-World Data (RWD): Experience with Real-World Data (RWD), demonstrated proficiency in working with diverse real-world data sources, including but not limited to: MarketScan, CPRD, TriNetX and STATinMED. Education: PhD in quantitative field such as Statistics, Biostatistics, Applied Mathematics or related field with 6 years of industry or academic experience; Relevant Master’s Degree, with 10 years of related industry or academic experience. Soft skills: Strong oral and written communication skills; ability to work and collaborate in a team environment Languages: Excellent knowledge of English language (spoken and written) Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! null Show more Show less

Job Title: Statistical Programmer (R) Location: Remote About the Role: We are seeking a talented Statistical Programmer with a strong background in R programming to join our dynamic team. In this role, you will collaborate with statisticians, data managers, and clinical researchers to deliver high-quality statistical programming support for clinical trials and research studies. You will be responsible for data preparation, analysis, and the generation of statistical outputs, ensuring compliance with regulatory standards. Key Responsibilities: Develop and validate statistical programs using R to support clinical trial analysis and data visualization. Create and maintain analysis datasets, summary tables, listings, and graphical presentations. Collaborate closely with statisticians to ensure accurate and efficient data analysis. Contribute to the development of statistical analysis plans (SAP) and programming specifications. Participate in data quality checks and data review processes. Ensure compliance with regulatory guidelines (e.g., CDISC, ICH, FDA) and internal quality standards. Troubleshoot and resolve programming issues related to data processing and analysis. Document programming work for transparency and reproducibility. Qualifications: Bachelor’s or Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field. 3+ years of experience in statistical & R programming within the pharmaceutical, biotechnology, or CRO industry. Proficiency in R programming, including package development and data manipulation. Strong understanding of clinical trial data and statistical methodologies. Experience with CDISC standards (SDTM, ADaM) is a plus. Show more Show less

Job Overview Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. Accountable for controlling costs and maximizing revenue recognition. Provide training, guidance and mentorship to lower level and new staff. Essential Functions Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution. Leadership: Perform statistical team lead role on single studies. Through this, works closely with the Project Team Lead and supervisor to deliver on time, with high quality and within budget. Build and maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities. Demonstrates and promotes efficient communication. If in lead role, runs meetings, documenting where necessary and following up on actions. Actively participates in internal project team meetings, provides timely progress updates. As a lead, will have input on estimate at completion (EAC) reporting. Data Management: Assist in reviewing or advising data management staff on database design, validation checks and critical data. Handles data issue resolutions. If in lead biostatistical role, handles lock and unblinding process with appropriate supervision. Statistical Analysis Plan (SAP) and Shells: Authors or performs quality control review (QC) of SAPs and shells. Make best use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). May author or QC complex SAPs, under supervision if needed. Datasets: Writes and maintains programming specifications. Programs assigned datasets to industry standards. Handles dataset derivations and assignment. Tables, Listings and Figures (TLFs): Writes programming specifications for statistical analyses outputs. Programs TLFs, maximizes programming efficiency with use of tools, where applicable. Checks resulting output for format and content, and questions specification as needed. Ensures consistency across items produced. Timelines: Plans and documents timelines, forecasts resource needs, suggests work may be out of scope. Financials: Shares accountability (with resource managers) for the financial success of assigned studies. Accountable for controlling costs and maximizing revenue recognition. Responsible for sharing budget expectations with the team. Raises concerns to manager if new work or rework appears to be out of scope. Understands 'scope of work' and has an awareness of contract and budget assumptions. Knowledge Sharing: Helps train staff regarding operational items. Mentors junior staff. Supports colleagues and provides motivation as needed. Risk Management: Identifies risks to project delivery and/or quality and spends time to proactively avoid as well as proposes solutions to mitigate risks. Where possible, anticipate risks to minimize need for study level escalations. Other Clinical Data Interchange Standards Consortium (CDISC) requirements: Leadership: Under supervision within Compound. May perform statistical team lead role on studies within a compound. In addition to the leadership responsibilities above, also prioritizes and takes proactive approach to gain efficiencies in work across protocols. Study Start up: Assist with protocol development, sample size calculation, protocol and case report form (CRF) review. Protocol: Authors or performs quality control (QC) review of the statistical section of a protocol (making best possible use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). Proposals: May be able to review and comment on proposals/budgets at a study level. May contribute to request for proposals (RFP). May be expected to present at bid defenses. Clinical Study Report (CSR): Reviews or drafts CSR or statistical report. Customer: On occasion, may serve as primary point of contact for customer. May also consult on operational topics with clients. Lock and Unblinding Process: Handles the database lock and unblinding process. May participate on the biostatistics randomization team (drafts randomization specifications and/or reduce or perform quality control (QC) review of randomization schedules). May serve as unblinded lead statistician. Other Responsibilities: As defined on ad-hoc basis by managers. May assist with cross functional collaboration. Qualifications Bachelor's Degree Biostatistics or related field and 7 years relevant experience Req Or Master's Degree Biostatistics or related field and 6 years relevant experience Req Or Ph.D. Biostatistics or related field and 5 year relevant experience Req Typically requires 6 + years of prior relevant experience, or equivalent combination of education, training and experience. Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience. Excellent written and oral communication skills including grammatical/technical writing skills. Excellent attention and accuracy with details. In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Familiarity with moderately complex statistical methods that apply to applicable clinical trials. Strong individual initiative. Strong organizing skills. Strong working knowledge of SAS computing package. Familiarity with other relevant statistical computing packages such as nQuery. Strong commitment to quality. Ability to effectively manage multiple tasks and projects. Ability to lead and co-ordinate small teams. Ability to solve moderately complex problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium CDISC/ADaM). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com Show more Show less

Internal/extrernal stakeholders, project team members, vendors Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis Support the electronic submission preparation and review Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and / or performs programming assignments with minimal supervision Support improvement initiatives Minimum Requirements: Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required. At least 3 years programming experience in industry recommended. For US positions: US military experience will be considered towards industry experience. Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs. Understanding of clinical data structure (e.g. CDISC standards) and relational database. Demonstrated skills in using software tools and applications, e.g., MS office, XML. Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Demonstrated ability to work in a team environment with clinical team members. Preferred Requirments: Minimum of 3 years clinical / statistical programming experience within pharmaceutical clinical development Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements Experience in other software packages (e.g. R) Experience with the Linux operating system IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com Show more Show less

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Data Analytics & Computational Sciences Job Sub Function Biostatistics Job Category Scientific/Technology All Job Posting Locations: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description Position Summary: The Principal Programming Lead is a highly skilled Programmer with expert knowledge of programming languages, tools, and complex data structures, industry standards. The position requires proven technical and analytic abilities and strong capabilities in leading activities and programming teams in accordance with departmental processes and procedures. As a highly experienced Principal Programming Lead, they apply expert technical, scientific, problem-solving skills providing innovative and forward-thinking solutions to ensure operational efficiency across assigned projects providing training, coaching, mentoring to other programmers. The Principal Programming Lead position is accountable for the planning, oversight, and delivery of programming activities in support of one or more clinical projects, compounds, or submissions of high complexity and criticality. In this role, the Principal Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables with a high degree of autonomy and provide leadership, direction and technical and project specific guidance to programming teams. In addition, this position may lead and contribute expert knowledge and technical skills to assigned delivery unit, departmental innovation, and process improvement projects. Principal Responsibilities Designs and develops efficient programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis requests. Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes. Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed. Shares knowledge and provides guidance and coaching to programmers in developing advanced technical and analytical abilities. Performs comprehensive review of, and provides input into, project requirements and documentation. Collaborates effectively with programming and cross-functional team members and counterparts to achieve project goals and independently manages escalations. As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality. Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental technical groups and programming portfolio leads. Contributes to and may lead departmental innovation and process improvement projects and may contribute programming expertise to cross functional projects/initiatives. May play the role of a Delivery Unit/Disease Area Expert. Ensures continued compliance of project/programs and required company and departmental training, time reporting, and other business/operational processes as required for position. Clinical Programming Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards. Responsible for implementation of data tabulation standards. Performs data cleaning by programming edit checks and data review listings and Data reporting by creating data visualizations and listings for medical monitoring and central monitoring. Statistical Programming Responsible for implementation of data and analysis standards ensuring consistency in analysis dataset design across trials within a program. Principal Relationships: The Principal Programming Lead reports into a people manager position within the Delivery unit and is accountable to the Portfolio Lead for assigned activities and responsibilities. Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations. Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources. External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups. Education And Experience Requirements Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth). Advanced degrees preferred (e.g., Master, PhD). Experience And Skills Required Approx. 6+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. In-depth knowledge of programming practices (including tools and processes). Working knowledge of relevant regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11) Project, risk, and team management and an established track record leading teams to successful outcomes. Excellent planning and coordination of project delivery. Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors. Excellent communication, leadership, influencing and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness adapting to rapidly changing organizations and business environments. Experience managing the outsourcing or externalization of programming activities in the clinical trials setting (e.g., Working with CROs, academic institutions) preferred experience. Demonstrated experience managing the outsourcing or externalization of clinical programming activities in the clinical trials setting (e.g., working with CROs, academic institutions) is preferred. Expert CDISC Standards knowledge. Expert knowledge of relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required for a Clinical Programming role. Excellent written and verbal communications and influencing and negotiation skills. Advanced knowledge of programming and industry standard data structures, thorough understanding of end-to-end clinical trial process and relevant clinical research concepts. Other Innovative thinking allows for optimal design and execution of programming development strategies. Development and implementation of a business change/innovative way of working. Show more Show less

Job Purpose We are looking for an experienced Data Scientist to work at one of our global biopharma customers on a range of Biostats models consulting and development engagements. They are expected to bring extensive knowledge in best practices on R package development, model development and deployment on Databricks, collaboration with version control systems, and familiarity with other topics such as data architecture and cloud infrastructure. Desired Skills And Experience  Candidates should have a B.E./B.Tech/MCA/MBA in Finance, Information Systems, Computer Science or a related field  Strong experience in R programming and package development  Proficiency with GitHub and unit testing frameworks.  Strong documentation and communication skills.  A background or work experience in biostatistics or a similar discipline (Preferred).  Expert Knowledge In Survival Analysis (Preferred)  Statistical model deployment, and end-to-end MLOps is nice to have.  Having worked extensively on cloud infrastructure, preferably Databricks and Azure.  Shiny development is nice to have.  Can work with customer stakeholders to understand business processes and workflows and can design solutions to optimize processes via streamlining and automation.  DevOps experience and familiarity with software release process.  Familiar with agile delivery methods.  Excellent communication skills, both written and verbal  Extremely strong organizational and analytical skills with strong attention to detail  Strong track record of excellent results delivered to internal and external clients  Able to work independently without the needs for close supervision and also collaboratively as part of cross-team efforts  Experience with delivering projects within an agile environment Key responsibilities include:  Evaluate and document R packages, including metadata and user-focused use cases.  Develop unit tests aligned with best practices in R package development.  Collaborate closely with internal stakeholders.  Design and implement technical solutions for Survival Analysis, based on statistical and business requirements  Develop professional quality R packages.  Provide consultancy on Biostats model development and deployment best practices.  Review and optimize code, integrate existing modelling code into packages.  Design and implement end to end modelling and deployment process on Databricks.  Support and collaborate with adjacent teams (e.g. products, IT) to integrate the modelling solution.  Continually innovate with the team and the customer on using modern tooling to improve model development and deployment.  Demonstrate high attention to detail, should work in a dynamic environment whilst maintaining high quality standards, a natural aptitude to develop good internal working relationships and a flexible work ethic  Responsible for Quality Checks and adhering to the agreed Service Level Agreement (SLA) / Turn Around Time (TAT) Show more Show less

Job Title: Clinical Standard and Bio Stats Job Location: Pan India (Preferrable: Delhi or Mumbai) Exp Range: 10 - 18 Years Job Description: Roles and Responsibility: Contributes in building Product and solutions in Digital Data Flow, along with Product Team by providing Subject Matter expertise and knowledge on Industry Trends. Contributes to build differentiated Product offerings to maximize Sales and increase number of customers on Product. Co-leads the global strategic positioning & roadmap from a business view for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics e.g. SDTM, ADaM, Regulatory Submission Packages and Data Management (EDC, non-CRF, eDTA), TFLs, SDR, USDM (e.g. STDM, ADaM.) Co-leads the design & development for these solutions from a business view Co-leads thought leaderships and external visibility (e.g. articles, webinars, conferences, cross-industry meetings), initiates advisory boards Supports business development team with customer presentations, RFI/RFP requests and go-to-market strategy. Initiates customer leaderships connects and strategic partnerships. Description: At least 7-18 years of global drug development experience in Digital Data Flow, metadata repository, clinical data standards, biometrics, EDC, eDTA, gained preferably at top-15 pharma companies or clinical research organizations (CROs) Extensive hands-on experience with Digital Data Flow, data collection standards, biostatistical programming, STDM, ADaM, TFL and regulatory submission packages, including innovative tools and strategies for automation. Experience in applying AI in standardization, SDTM, ADaM and TFL generation. Experience in strategy setting for generating EDC build from study protocol, SDR Model, USDM Experience in innovative ways to automate testing and validation Track record of building respect and trust with customers, employees and other internal and external stakeholders and partners. Broad cross-pharma senior management network & preferably cross-industry forum expertise (e.g. CDISC, Transcelerate, IMI) Outstanding communication skills with ability to translate technology in a clear & easy-to-understand language Strong interpersonal skills including negotiation skills, facilitation skills and ability to drive for clarity and results when faced with ambiguity. Masters degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage

The Senior Manager of Biostatistics/Associate Director is a member of cross-functional study/project teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. These individuals develop collaborative relationships and work effectively with the Biostatistics Lead, and other cross functional team members. Key Responsibilities Contributes to designing clinical trials to address study hypotheses and objectives. Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications, and other study level specification documents under supervision. Performs and/or validates preplanned or ad hoc statistical analyses with guidance as needed. Presents & interprets results to GBDS and/or cross-functional team members. Translates scientific questions into statistical terms and statistical concepts into layman terms. . Qualifications & Experience MS in statistics, or biostatistics or related scientific field with 9+ years’ experience in clinical trials, drug development, pharmaceutical industry or healthcare experience (including internship) preferred. Proficiency in scientific computing/programming (SAS, R or Python) and implementation of statistical analysis, data manipulation, graphing & simulation. Show more Show less

Overview Jhpiego is a nonprofit global health leader and Johns Hopkins University affiliate that is saving lives, improving health, and transforming futures. We partner with governments, health experts, and local communities to build the skills and systems that guarantee a healthier future for women and families. Jhpiego translates the best science and practices into moments of care that can mean the difference between life and death for women and families. The moment a woman gives birth, the moment a midwife helps a newborn to breathe. Through our partnerships, we are revolutionizing health care for the world’s most disadvantaged and vulnerable people. In India, Jhpiego works across various states in close collaboration with national and state governments, providing technical assistance in the areas of family planning, maternal and child health, strengthening human resources for health, and non-communicable diseases. These programs are funded by USAID, the Bill & Melinda Gates Foundation, the David & Lucile Packard Foundation, GIZ, the Children’s Investment Fund Foundation (CIFF), and other anonymous donors. We are looking for a highly motivated and detail-oriented individual to assist in our research and learning efforts for the RISE (Reaching Impact Saturation and Epidemic Control) project. The successful candidate will work under the Senior Monitoring, Evaluation, Research, and Learning Officer, focusing on quantifying the impact of our programs on infectious disease outbreaks through rigorous mathematical/epidemiological modeling and advanced statistical techniques. Responsibilities End-to-end outbreak modelling – independently code, calibrate and run basic compartmental, agent-based models or other statistical models (e.g., SIR/SIRS/SEIR, time-series regressions) to estimate outbreaks averted, life saves from specific interventions and forecast near-term trends. Use counterfactual scenarios to quantify the impact of interventions by comparing modeled outcomes with and without specific response strategies and simulate the impact of resource allocation on outbreak outcomes to inform resource planning. Data acquisition & cleaning – source routine surveillance and programme datasets, write reproducible scripts to clean/merge them, and document data dictionaries. Incorporate demographic factors (e.g., age, comorbidities, population density) and epidemiological data (e.g., case fatality rates, transmission rates) into models to improve the accuracy of lives saved estimates for specific populations and adjust models to account for India-specific health system constraints and regional variations in outbreak dynamics Parameter estimation & uncertainty analysis – fit models to data with likelihood-based or simple Bayesian methods; produce confidence/credible intervals and sensitivity checks. Regular analytic reports – generate clear tables, graphs, and slide decks that translate model outputs into actionable insights for programme managers and donors. Generate reports and visualizations summarizing lives saved and infections averted, tailored for policymakers, donors, and program teams Conduct analytics (Bayesian/MLE calibration, uncertainty quantification, ensemble forecasting) and translate results into dashboards and briefs for programme teams and donors. Evidence scans – conduct rapid literature reviews on modelling methods and intervention impact; keep a living repository of key parameters and priors. Perform systematic literature reviews and landscape analyses of outbreak-response interventions. Draft manuscripts, policy briefs, and donor reports; shepherd them through peer review. Tool development & maintenance – build and update simple R Markdown / Python notebooks or Shiny/Dash dashboards so non-technical colleagues can explore scenarios. Documentation & reproducibility – maintain well-commented code, version control (Git), and workflow descriptions to ensure analyses can be audited or handed over smoothly. Team liaison & capacity sharing – explain modelling assumptions and outputs to epidemiologists, programme staff, and leadership; train program staff on interpreting lives saved estimates and using simplified impact modeling tools for decision-making Collaboration with modelling groups: Engage with national modeling consortia (e.g., Indian Council of Medical Research, WHO, or academic groups) to align lives saved estimates with standardized methodologies, share best practices and contribute to collaborative modeling efforts to estimate the cumulative impact of multi-partner interventions during large-scale outbreaks. Emergency surge support – update models and situation summaries during outbreaks as part of the duty rota. Other duties as assigned by your supervisor Required Qualifications Master’s degree (completed or in final semester) in Biostatistics, Epidemiology, Applied Mathematics, Data Science, Computer Science, or related field. Up to 2 years’ relevant experience or strong internship/thesis work involving infectious-disease modelling, statistical analysis, or data science. Working knowledge of R or Python for data analysis and visualisation; familiarity with version control (Git/GitHub). Solid grounding in statistical inference (regression, likelihood-based methods) and basic compartmental modelling concepts (e.g., SIR). Ability to explain quantitative findings clearly in written and verbal English; strong organisational skills and attention to detail. Proven teamwork mindset and willingness to learn new methods quickly. Desirable Exposure to Bayesian tools (Stan, JAGS), geospatial/GIS packages, or dashboard frameworks (Shiny, Dash, Power BI). Coursework or project experience in infectious-disease epidemiology, vaccine impact evaluation, or health-economic modelling. Experience cleaning large relational datasets (SQL, PostgreSQL) or using cloud notebooks (JupyterHub, RStudio Server). One or more publications, preprints, or conference posters based on quantitative research. Familiarity with global health and Indian public healthcare delivery systems. Jhpiego is an equal opportunity employer and offers a highly dynamic and enabling work environment. Jhpiego offers competitive salaries and a comprehensive employee benefits package. Women candidates are encouraged to apply. Due to the high volume of applications, only shortlisted applicants will receive a response from Jhpiego HR RECRUITMENT SCAMS & FRAUD WARNING Jhpiego has become aware of scams involving false job offers. Please be advised: Recruiters will never ask for a fee during any stage of the recruitment process. All active jobs are advertised directly on our careers page. Official Jhpiego emails will always arrive from @Jhpiego.org email address. Please report any suspicious communications to Info@jhpiego.org. Show more Show less

The Costing Manager I is a position that sits within the Costing Department, as part of the Enterprise Client Solutions group. The role is primarily charged to develop proposals and pricing solutions for Biometrics services, working individually and/or with the Costing Directors and will predominantly liaise with the Biometrics Management teams and the Costing Directors on a daily basis. Interactions with other functional roles from Strategy and Planning, Therapeutic Area Business Units, Project Management Centre of Excellence, Client Services, Business Development, Global Clinical Trial Organization (GCTO), Biometrics, Drug Safety and Global Regulatory Services will also be necessary in accomplishing the job. Essential Job Duties Serves as a Costing Manager to support the costing department to ensure clear alignment of project costings to customized delivery strategy by performing but not limited to the following tasks: Review RFP scope and specs and initiate the costing process by initial update of the pricing tool and ensure that this is updated and accurate on an ongoing basis during the cost finalization process Review, update and adjust the initial system generated default budget independently or after feedback and direction from costing director/s and other stakeholders Attend all team meetings during the RFP process like but not limited to- risk assessment for RBM, strategy, pricing specification, pricing delivery or challenge call, senior management call and bid defense preparation Lead and deliver the full proposal, ballpark, abbreviated response, letter and/or re-cost estimates by accomplishing the complete RFP process independently with administrative support from Proposals Associate. Deliver individually or under supervision from the Costing Director and manage all delegated aspects of costing compilations for RFP responses and non-compete awarded projects. Determine appropriate Biometrics scope and deliverables for new RFPs based on available Protocol and/or Synopsis and schedule of events (SoE) Establish and maintain a close relationship with Biometric leadership to ensure new technologies and platforms are accurately reflected in proposal response. Review proposed pass through items and costs for new RFPs and request adjustments if required to ensure accurate pass through costs Review and respond to queries from vendors during RFP phase, review proposed vendor quotes and request adjustments in consultation with costing director/s if required to ensure accurate vendor costs Support writing and review of the assumptions document included in RFP response to ensure accuracy and alignment with the proposed budget Support writing and review of RFI response to ensure questions have been accurately addressed and aligned to current business practices as defined in Standard Operating Procedures Liaise with Biometrics management for project resource assignments and handover requirements during the RFP or on award as necessary. Negotiate for team assignments with relevant experience and availability after review of the proposed CVs. Review and coordinate with pricing to ensure accurate mapping and finalization of client budget grid with Fortrea WBS codes Support and contribute to ongoing updates of Biometrics algorithms by working in close coordination with the costing director/s, Biometrics Management and other relevant stakeholders. Contribute to the costing director team in any strategic process improvement initiatives Perform other duties as assigned by management of the Costing Department Qualifications (Minimum Required) Bachelor's degree or equivalent and relevant formal academic qualification Experience (Minimum Required) A minimum of 6 years of experience in either Data Management or Biostatistics or Statistical programming with a CRO/pharma/other related experience to successfully perform the essential job duties Excellent customer service skills, attention to detail and ability to be persistent while maintaining tact Demonstrated computer skills – requires excellent MS Office experience (specifically Excel, Word, Outlook) Demonstrated text editing and writing skills (based on business unit and/or team expectations) Demonstrated ability to plan, multi-task and prioritize Demonstrated teamwork, communication (written and verbal), and organizational skills Proven ability to work independently Ability to work to deadlines Strong analytical skills Ability to communicate appropriately and effectively with internal stakeholders, clients and Fortrea senior management Positive attitude and sense of urgency Ability to work across Fortrea Business Units Should be comfortable working in the 2nd shift (2 – 11 pm IST) Learn more about our EEO & Accommodations request here. Show more Show less

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Data Analytics & Computational Sciences Job Sub Function Biostatistics Job Category Scientific/Technology All Job Posting Locations: PENJERLA, Telangana, India Job Description Position Summary The Principal Statistician supports the design, execution, analysis, interpretation, and reporting or communication of data evidence for Pre/Early/Late Clinical Development, Research & Discovery, Medical Affairs, Real World Evidence, or Manufacturing Sciences programs for research, development, and/or marketed product needs in Janssen, with minimal supervision. This position supports statistical aspects of business-critical and/or regulatory commitments, provides input to program plans with limited supervision, and represents Statistics & Decision Sciences (SDS) for cross-functional and intra-departmental teams or working groups. He/She abides by the Credo and practices J&J Leadership Imperatives for Individuals: Lead, Shape, Connect, and Deliver. Position Core Competencies, Responsibilities And Accountabilities Expertise: Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful program support. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability. Quality and Compliance: Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understands and aligns with relevant regulatory guidances. Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical trial team, and the Statistics Area Head. Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards. Follows best practices for Data Integrity. Drug Development : Demonstrates thorough knowledge of pharmaceutical research and development strategies and execution. Takes a lead in providing SDS support to experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications. Is accountable for execution of individual project responsibilities, including: meetings with necessary project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects. Is an evolving leader for providing input to team in terms of optimizing study or trial designs in line with study or indication level objectives, and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge. Disease Area Knowledge: Demonstrates knowledge for at least one disease area/target . Innovation: Suggests and performs the evaluation of alternative or innovative approaches to statistical methods or business processes. Representation: Represents Statistics & Decision Sciences for cross-functional and intra-departmental teams or working groups relating to scientific or process initiatives. External Engagement: Participates as a member of professional organizations, e.g. by attending meetings as chair or presenter. Mentor: Supervises contractors/special assignment personnel/interns/co-ops as required. Mentors junior colleagues in techniques, processes, and responsibilities. Process: Participates in process improvement or standards development initiatives. Complexity: Works on increasingly more complex programs after mastering standard ones. Proactively identifies complexity in terms Scientific, Statistical, Health Authority, Operational, and Partnership issues. Collaboration: Builds cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations (CROs), consultants) to achieve results for project specific needs with focus on improving communication, efficiency, and productivity. Works cross-functionally to identify and resolve issues. Communication: Has very good written, oral, and interpersonal communication skills. Demonstrated ability to collaborate and consult with non-statisticians, translating complex statistical concepts to drug research & development partners. Bridges scientific and business needs – integrating quantitative sciences and strong disease or functional area knowledge and appropriate market/competitive intelligence. Programming: Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required. Area Specific Core Competencies, Responsibilities And Accountabilities These are additional to the above position core competencies, applicable to individuals according to their assigned area within Statistics & Decision Sciences. Discovery & Translational Documents projects in sufficient detail for reproducibility. Serves as initial consultation contact for new projects. Maintains and grows customer base, and builds loyal relationships with customers. Assumes independent, professional responsibility for all phases of a project request from beginning through completion, with minimal supervision as needed. Manages multiple projects. Leads Statistical Input for at least one functional area, research field, or compound. Provides input to product development and performs statistical functions for submission related activities where appropriate. Statistical Modeling & Methodology Support broad implementation of innovative statistical approaches across the development portfolio. Support development and implementation of innovative approaches, participating in their hands-on implementation through direct interactions with statisticians. This involves, but is not limited to, identifying appropriate designs and methods, decision rules (e.g., Go/No Go); planning, running, and summarizing simulation studies to evaluate the operating characteristics of alternative designs and methods under a range of scenarios; and participating in the implementation of the selected approaches by engaging in protocol and SAP write-up. Collaborate with external consultants to provide support in the development and implementation of innovative methods and designs. Identify opportunities for innovation; interact directly with statisticians and other QS scientists for early identification of opportunities for innovative approaches. Participate in training and presentations on innovative approaches across the R&D organization (including statisticians, pharmacometricians, clinicians, and other stakeholder groups) to ensure awareness and adequate knowledge about these methods. Keep up-to-date knowledge of designs and analysis methods for clinical trials, including adaptive designs, model-based methods, etc. May engage in external collaborations within professional associations (e.g., ASA, IBS, SCT, ISoP, ISCB, PSI, EFPSI), participating in working groups, program committees, organizing sessions and presenting at scientific meetings, and publishing in peer reviewed journals. Knowledge of biostatistics applied to clinical trials and model-based drug development. Some experience with planning, running, and documenting simulations (including, but not limited to clinical trial simulations). Awareness of Bayesian methods and inference. Manufacturing & Toxicology Documents projects in sufficient detail for reproducibility, including entry in project tracking systems and placement into shared repositories. Serves as initial consultation contact for new projects. Maintains and grows customer base, and builds loyal relationships with customers. Assumes independent, professional responsibility for all phases of a project request from beginning through completion, with minimal supervision as needed. Manages multiple projects. Leads Statistical Input for at least one functional area, research field, or compound. Provides input to product development and performs statistical functions for submission related activities where appropriate. Medical Affairs Provides critical statistical oversight to Medical Affairs clinical studies and assumes a leadership role in clinical trial and/or patient registries planning (mostly Phase 3b/4 trials or observational studies for post marketing commitments/requirements) and reporting related activities; assumes the role of a Statistics representative for cross-functional teams and works on several trials (projects) simultaneously. Provides statistical input for clinical trials, observational studies and other types of clinical research projects including but not limited to post-hoc analyses, investigator initiated studies, publications, and HECOR/Epidemiology/Market Access support; Contributes/leads clinical study design, analysis planning and for the development of statistical analysis plan (SAP) and data presentation plan (DPS) for MA studies; Provides input to product development and performs statistical functions for submission related activities; Provides statistical support to other disciplines related to clinical statistics (e.g., HECOR/Epidemiology and publication activities); May serve as a primary contact with outside investigators (and vendors)in the preparation of scientific presentations and manuscripts; may interact with external Key Opinion Leaders (KOLs) and pursues rigorous statistical analyses in support of business-critical new research ideas; Explores and implements innovative statistical methods; Represents department in meetings with regulatory agencies. Real World Evidence Proactively interface with clinical teams to identify opportunities where real-world data analysis can support the clinical development feasibility assessment; Serve as liaison between the TA Clinical Teams and the Epidemiology Analytics Team to facilitate the translation of protocol Inclusion/Exclusion criteria into meaningful data definitions, and to track and measure outcomes; Work with RWE Feasibility Lead to shape and influence the future of protocol development through the use of novel technology applied to real world data to enhance data-driven operational decision making; Work closely with key stakeholders, including the Study Placement & Analytics group and the Clinical Program Leader, to run RWE analysis that support protocol design and protocol feasibility. Supervision and Reporting Relationships This position reports to a Director or above, and is an individual contributor position. Interfaces Internal: Statistics & Decision Sciences, Clinical Pharmacology & Pharmacometrics, Clinical Teams (or Equivalent) and associated working groups, Statistical Programming, Medical Writing, Leaders and Scientists within Therapeutic and Functional Areas, R&D Operations, Medical Affairs, Manufacturing, Safety, Regulatory Affairs, Quality, Human Resources, Information Technology, Finance. External: Contracted Partners, Academia, Professional Societies, Private and Public Consortia. Education And Experience Requirements Ph.D. in Statistics or related field with minimum 3 years relevant experience, or Master’s in Statistics or related field with commensurate years of relevant experience. Proficient in SAS or R programming. Good written, oral, and interpersonal communication skills. Ability to work independently. Demonstrated ability to work in interdisciplinary contexts outside statistics. Show more Show less

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Data Analytics & Computational Sciences Job Sub Function Biostatistics Job Category Scientific/Technology All Job Posting Locations: PENJERLA, Telangana, India Job Description Position Summary The Senior Statistician provides statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product needs in Janssen. This position supports statistical aspects of business-critical and/or regulatory commitments. He/She abides by the Credo and practices J&J Leadership Imperatives for Individuals: Lead, Shape, Connect, and Deliver. Position Core Competencies, Responsibilities And Accountabilities (including lower pay grade level requirements not explicitly re-stated here) Expertise: Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a track record of applied experience. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability. Ensures application of appropriate statistical methods and generation of accurate and reproducible results working independently or by providing specifications to statistical programming colleagues. Produces clear, concise, well-organized, and error-free computer programs and statistical reporting content. Quality and Compliance: Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understands and aligns with relevant regulatory guidances. Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical trial team, and the Statistics Area Head. Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards. Follows best practices for Data Integrity. Drug Development: Acquires and demonstrates knowledge in pharmaceutical research and development strategies and execution. Assists in providing experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications support. Is accountable for execution of individual project responsibilities, including: meetings with necessary project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects. Provides critical input to the statistical lead or team in optimizing study or trial designs in line with study or trial objectives, and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge. Collaboration: Establishes and maintains effective and efficient interfaces and relationships with internal and external customers, with support of Statistics & Decision Sciences (SDS) management. Routinely contributes to area (e.g. discovery, translational, early development, late development) project meetings. Contributes positively to SDS team dynamics with a clear understanding of the SDS vision. Programming: Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required. Process: Deep knowledge of data architecture, such as Data Standards. Recognizes the need and value of process standardization. External Engagement: Participates as a member of professional organizations, such as attending meetings sponsored by professional organizations. Area Specific Core Competencies, Responsibilities And Accountabilities These are additional to the above position core competencies, applicable to individuals according to their assigned area within Statistics & Decision Sciences. Discovery & Translational Serves as initial consultation contact for new projects. Maintains and grows customer base, and builds loyal relationships with customers. Assumes independent, professional responsibility for all phases of a project request from beginning through completion, with minimal supervision as needed. Manages multiple projects. Documents projects in sufficient detail for reproducibility. Statistical Modeling & Methodology Not Applicable. Manufacturing & Toxicology Serves as initial consultation contact for new projects. Maintains and grows customer base, and builds loyal relationships with customers. Assumes independent, professional responsibility for all phases of a project request from beginning through completion, with minimal supervision as needed. Manages multiple projects. Documents projects in sufficient detail for reproducibility, including entry in project tracking systems and placement into shared repositories. Medical Affairs Provides statistical support to Medical Affairs studies and assumes responsibilities for planning, design and analysis of randomized clinical trials, observational studies and/or patient registries for post marketing commitments/requirements and reporting related activities. Applies sound statistical thinking and computational abilities in support of Medical Affairs goals & objectives. Contributes in the planning, design, conduct and analysis for clinical trials, observational studies and other types of clinical research projects including but not limited to post-hoc analyses, investigator initiated studies, publications, and HECOR/Epidemiology/Market Access support; Develops statistical analysis plans (SAPs) and data presentation specifications (DPSs); Provides statistical support for all LCM/regulatory-submission related activities; Interacts with other Medical Affairs functional groups (e.g., HECOR/Epidemiology, Market Access and publication teams); in close partnership with statistical lead, interacts with outside investigators (KOLs and vendors) in the preparation of scientific presentations and manuscripts and pursues implementation of robust statistical analyses in support of business-critical evidence generation; Explores and implements innovative statistical methods. Real World Evidence Not Applicable. Post Marketing Surveillance (PMS) Provide advanced statistical expertise in PMS programs, study design, data analysis and interpretation of results for PMS studies. Assume independent, professional responsibilities for analysis operations. Lead study design, analysis planning and for the development of statistical analysis plan (SAP) and data presentation plan (DPS) for PMS studies. Monitor the analysis operations conducted by vendors, an oversees design and implement quality control measures to ensure the quality and integrity of statistical results. Provide consultancy for statistical questions from medical affairs/business units or external customers. Interacts with outside investigators (Key Opinion Leaders (KOLs) and vendors) in the preparation of scientific presentations and manuscripts. Implement “state‐of‐the‐art” statistical approach and technology. Contribute to the implementation of continuous process improvements while maintain sustainable efficiency in globally consistent processes, such as data standards and process standardization. Basic knowledge of project management. Supervision and Reporting Relationships This position reports to a Director or above, and is an individual contributor position. Interfaces Internal: Statistics & Decision Sciences, Clinical Pharmacology & Pharmacometrics, Clinical Teams (or Equivalent) and associated working groups, Statistical Programming, Medical Writing, Leaders and Scientists within Therapeutic and Functional Areas, R&D Operations, Medical Affairs, Manufacturing, Safety, Regulatory Affairs, Quality, Human Resources, Information Technology, Finance. External: Contracted Partners, Academia, Professional Societies, Private and Public Consortia. Education And Experience Requirements Ph.D. in Statistics or related field with minimum 0-2 years relevant experience, or Master’s in Statistics or related field with commensurate years of relevant experience. Basic knowledge of SAS or R programming. Good written, oral, and interpersonal communication skills. Show more Show less

Key Responsibilities: Responsible for managing and reporting of accurate and on time Global Quality metrics for Product Quality Complaints (PQC) in a fast-paced environment that support Tier Councils, Product Quality Complaint compliance & trending across the organization, internal & regulatory audits. Expertise with data management and analysis using electronic software solutions, eg VEEVA, Tableau, SpotFire, and Microsoft Office, with focus on Excel, PowerPoint, and SharePoint. Responsible to maintain a high level of knowledge & understanding of Pharmaceutical/Biologic Quality Assurance, Device Quality Assurance, cGood Manufacturing Practices as applicable in global GMP regulations (including FDA, EMA, MHRA, PMDA, ENVISA, TGA). Responsible to develop & maintain tools and dashboards in support of PQC trending, data surveillance and PQC user support. Responsible to provide PQC data assessments, highlighting trends, signals and risks and business critical information related to Product Quality Complaint data to Quality leadership in a timely fashion. Data & trend assessments will be communicated with stakeholders in a manner commensurate with risk, and enabling appropriate action taking to protect BMS and our patients. Responsible to complete required training and provide support for Product Complaints, Product Surety and Quality Serialization business process activities. You are accountable for other key activities that support the business such as: SharePoint design, data requests/analysis, and providing communication of trends, signals and risks in addition to business critical information to leadership Maintain expertise on PQC data management at BMS, including data sources, data quality, data management, data users Report at appropriate intervals (weekly, monthly, quarterly, year-on-year etc) metrics on key compliance indicators related to PQC performance and procedural compliance (for example on-time closure, increasing/decreasing trends by product/defect category/market etc). Review signals and trends that may present a risk to the organization and/or to our patients. Engage with PQC management and appropriate stakeholders to identify corrective actions. Align with PQC management for escalations to Quality leadership. Provide recommendations and communications based on output from analytical tools and visualizations. Provide risk assessment support for PQC processes, data management and related activities Continuously improve process for assessment and reporting PQC data to drive consistency and understanding of Quality compliance-focused metrics Use Operational Excellence and similar approaches to support the design of metric tools that facilitate proactive discussion and provide visibility/transparency to drive continuous improvement, prioritization and product quality related decisions Lead teams in the development of tools and reports to optimize and standardize metrics Lead collection and review of PQC data in response to health authority requests Lead collection and review of PQC data in support of audit requests (internal and external audits) Lead metrics initiatives related to product quality complaint programs and processes Facilitate and drive standards for communication, management and visibility of product quality support metrics Implementation and timely update of information to ensure content is current and accurate Establish appropriate procedural documents for product quality support metrics Cross train in other areas of the Global Quality organization to assist the business in developing its employees Develop and maintain high quality relationships with key stakeholders Work on multiple projects at one time and manage priorities based on timelines Work independently with a high degree of professional integrity, be highly organized, and be detail-oriented Perform duties as aligned with PQC management Qualifications & Experience: Degree/Certification/Licensure Bachelor of Science degree in data analytics/statistics/biostatistics, engineering, chemistry, biology, or other quantitative field. Advanced degree preferred. Required Competencies: Fluent in English, with proven professional working proficiency in English for reading, writing and speaking Excellent communication with management, peers, and other functional areas Excellent ability to analyze data to extract useful information and trends, and to translate data to effective messaging to stakeholders and leaders supporting effective decision-making Ability to work well cross-functionally with stakeholders Ability to influence positively in a matrix environment Proven ability to understand complex processes/problems and propose alternate solutions Customer and partner focus, including the ability to listen to and incorporate feedback from key stakeholders Demonstrated Enterprise mindset to be able to think and act across functions and divisions Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats Demonstrated strategic thinking capability and ability to balance conflicting priorities Ability to provide innovative ideas or alternatives that create value including seeking new information and external insights without compromising compliance Ability to clearly articulate analytical needs to functional partners Experience – Responsibility and minimum number of years: A minimum of 5 years of experience in a data analytical role, or in a Quality role where data analytics was a key component in the pharmaceutical/ biotech/ device industry Strong working knowledge/experience with systems such as QMS, SAP/ERP, Veeva Experience with understanding how to respond to trend signals within the context of quality surveillance Strong problem solving skills are required Strong program and project management Ability to manage multiple, simultaneous projects Thorough understanding of Quality Risk Management Mastery of relevant Quality compliance processes and regulations Understanding of technical areas related to pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, microbiological Show more Show less

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. Overview The Senior Clinical Data Manager (Sr. CDM) independently acts as a study lead and is responsible for the oversight, maintenance, and management of clinical trial database(s) for assigned projects throughout the full data management lifecycle. The Sr. CDM is viewed as the CDM expert fostering cross-functional collaboration across clinical operations, biostatistics, and programming teams. Serves as the primary CDM Subject Matter Expert between eClinical personnel and Sponsor personnel. The Sr. CDM will create and oversee the database design specifications, validation, maintenance/data cleaning, and closeout activities of project-specific clinical trial databases. The Sr. CDM may delegate tasks/responsibilities to multiple team members in multiple projects. The Sr. CDM will provide ongoing project oversight to ensure proper planning and timely completion of high-quality Sponsor deliverables. Key Tasks & Responsibilities Primary representative for eClinical Solutions/Sponsor data management interaction, ensure eClinical Solutions data management process is followed and deliverables meet quality and timelines within approved Scope Senior technical resource providing Data Management services for project requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, Query Management, Vendor Reconciliation Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities Perform Quality Control on deliverables developed by team members including study documents, program and report specifications, deliverables and elluminate® Data Central and analytics modules Function as senior DM consultant to sponsor providing guidance on data management best practices as applied to sponsor and protocol specific situation Perform data trending review via reporting and elluminate analytics to identify risks and develop mitigation and data cleaning strategies Monitor and interpret key performance indicators (KPIs), dashboards, and reports to provide actionable recommendations to client Delegate and prioritize tasks, provide project oversight and guidance to study data management team mentoring junior level staff and peers on all associated tasks within a study helping to grow individual capabilities Support business development by participating in proposal defenses Maintain project documentation related to assigned tasks Other duties as assigned CANDIDATE’S PROFILE Education & Experience 8-10 years of experience in Clinical Data Management Bachelor’s degree in health-related field or equivalent experience Professional Skills Strong project management experience and project team leadership skills including work planning and work delegation Strong consulting and client relationship management skills Detail oriented, ability to multitask with strong prioritization, planning and organization skills Excellent verbal and written communication skills Excellent team player Excellent knowledge of English Technical Skills Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology Proficient with EDC and Clinical Data Management Systems Experience with data reporting tools such as Qlik, JReview, Spotfire Experience with RBQM methodology preferred Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need. Show more Show less

1. Title: Research Writer 2. Qualification:- · Candidates must have a PG and Ph.D. in Medical Health Science stream. 3. Salary Range: · As per the industry norms 4. Roles and Responsibilities: · Should have research writing experience. · Should be familiar with the latest Research Methodologies. · Should have worked in similar role in Medical Research institutions. · Demonstrated expertise in statistical methods for analyzing large datasets, particularly clinical samples, and their associated information. · Must have experience with data management and analysis in a healthcare research setting. · Need to have excellent oral and written communication skills. · Strong organizational, analytical, and reasoning skills · Ability to work well and flexibly i.e. autonomously, in small teams, and with a wide range of varying stakeholders · To have a strong knowledge of various statistical software packages commonly used in biostatistics / Medical Statistics such as R, SAS, STATA, MATLAB, SPSS · Must have published research findings in high-impact peer-reviewed journals and present at national and international conferences. · Should have collaborated with interdisciplinary teams of researchers to address complex biological questions through computational approaches. · Need to stay current with developments in research field through continuous learning and professional development activities. · Contributed to the academic community through participation in professional organizations, conferences, and peer review activities. Job Types: Full-time, Permanent, Fresher Pay: ₹35,000.00 - ₹50,000.00 per month Benefits: Provident Fund Schedule: Day shift Morning shift Rotational shift Education: Doctorate (Preferred) Experience: total: 1 year (Preferred) Work Location: In person

Assistant Professor 0-1 1 Raipur, 493661 Job Description Requirement Details Basic Qualification MBBS from a recognized institution Postgraduate Degree MD in Community Medicine/ Preventive and Social Medicine from an NMC-recognized medical college Core Teaching Responsibilities Teach MBBS students key topics in: Epidemiology , Biostatistics Environmental & Occupational Health Health Programs and Policies Demography , Health Economics Conduct: Tutorials , lectures , and field-based learning Internal assessments, MCQs, and problem-based learning aligned with CBME Field Work & Community Engagement Supervise undergraduate postings in: Urban Health Training Centre (UHTC) Rural Health Training Centre (RHTC) Participate in: Health camps , immunization drives, surveys, and awareness campaigns Community outreach for maternal-child health, vector-borne disease control, etc. Assist in collaborations with local health authorities and government health schemes Research & Development Engage in community-based or institutional research: KAP studies, intervention assessments, epidemiological surveillance Support: Data collection and biostatistical analysis Preparation of conference papers, posters, and publications Attend and present at: Public health seminars, CMEs, IAPSM meets, and training programs Full Time 2200k Year Community Medicine Contact us For more information, contact us on admin@vitalityhealthcare.in

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

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

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

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

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

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

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

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