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5.0 - 10.0 years
15 - 30 Lacs
Hyderabad
Remote
Role & responsibilities Collaborates with field experts in Research and Pre-Clinical Development to plan, execute and analyze relevant experiments independently, notably design of experiments feasible under given lab conditions, support of sample-size calculations and application for animal testing licenses, randomization, data transfer into appropriate stats software, interpretation of results. Takes statistical responsibility for one or more standard experiments. Develops the statistical analysis plan for the experiments as appropriate, ensuring overall consistency within and between projects. Facilitates the overall organization and coordination of statistical activities for specific experiments and small projects. Leads virtual cross-functional sub-teams within NCS/SIS of DS&AI. Assumes responsibility for the production and accuracy of the statistical deliverables and interpretation of the results. Works independently at routine and complex statistical questions and tasks. Develops and implements standard processes for the analysis of routine experiments. Oversees and ensures accurate and timely delivery of statistical work outsourced to external providers. What we're looking for Qualifications & Competencies: PhD or MSc in Biostatistics, Statistics or Mathematics, or related field. Strong communication skills. Ability to work independently as well as collaboratively, as required. Ability to translate statistical results into biological meaning Good knowledge of statistical programming languages (including SAS and R). Fluent English skills. At least two years as a non-clinical statistician focused on in vivo and in vitro experiments with significant time spent in pharma, biotech or similar sector.
Posted 1 month ago
2.0 - 6.0 years
8 - 8 Lacs
Mumbai
Work from Office
Hello Candidate , We are #hiring for Project Research Scientist-I (Non Medical) ! Government Project Payroll company: - E Solutions Job role: - Project Research Scientist-I (Non Medical) ! Educational Qualification First Class M.Sc. In Life Sciences/Genetics/Clinical Research/Biostatistics from recognized University. Desirable Qualification Ph.D. in Life Sciences/Biotechnology/Microbiology with 2 years research experience, in immunology molecular biology techniques. No. of Vacancy :- 1 Age Limit: The upper age limit is 35 years Interested Candidate can share your CV on this Email ID :- anchal.g@esolglobal.com
Posted 1 month ago
8.0 years
9 - 11 Lacs
Hyderābād
Remote
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities: Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable): Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results Skills, knowledge, and experience Minimum Requirements: Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members. Preferred Requirements: Management experience supervising technical professionals. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 1 month ago
10.0 years
0 Lacs
Pune, Maharashtra, India
Remote
ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, our most valuable asset is our people. Here you’ll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning; bold ideas; courage and passion to drive life-changing impact to ZS. Our most valuable asset is our people . At ZS we honor the visible and invisible elements of our identities, personal experiences and belief systems—the ones that comprise us as individuals, shape who we are and make us unique. We believe your personal interests, identities, and desire to learn are part of your success here. Learn more about our diversity, equity, and inclusion efforts and the networks ZS supports to assist our ZSers in cultivating community spaces, obtaining the resources they need to thrive, and sharing the messages they are passionate about. ZS’ R&D Excellence Practice brings together experts in Strategy, Clinical Execution, Data Sciences and Technology to empower client organizations to achieve their passion for patient care, science and business success. Through our “Lifecycle Evidence Strategy”, “Clinical Trial Optimization”, “Medical Affairs” and “Evidence Generation” services, we deliver impact where it matters, from early drug development to commercialization. This role will be aligned with ZS’s R&D Excellence Practice Area, and particularly within our Evidence Generation practice, supporting our business consulting and analytics services across multiple clients. HEOR/Evidence Synthesis Lead: We seek applicants for a Evidence Synthesis Lead role. This is an important leadership role within our Health Economics and Outcomes Research (HEOR) team, part of our Evidence Generation practice. Our vision is to elevate HEOR into a strategic function which bridges the scientific, clinical and commercial spheres, and be the world leading strategic HEOR consultancy. As well as providing core HEOR services, we aim to shape the policy landscape HEOR operates within, be benevolent disruptors, driving the adoption of innovative new approaches, and make HEOR part of the entire product lifecycle. ZS has an inclusive, client centric, consultancy culture, based around our core values: Treat people right Get it right Do the right thing The successful candidate will be someone excited by and aligned to this vision and culture. Responsibilities: Leading evidence synthesis standalone projects and workstreams on broader engagements, as the person responsible for overall quality, timelines, and financial performance Developing recommendations based on expected impact, communicating risks and opportunities to ensure staff alignment, and where appropriate assuming the role of final decision maker Reviewing and signing off on deliverables including protocols, analysis plans, technical reports, and slides Work closely with ZS client teams to lead client business development and client relationship development across our key client accounts; Owning relationships with clients and being viewed as subject matter expert; proactively managing client expectations and working with team members to implement strategies to problem solve on a client or project-basis Leading team development and mentoring, encouraging a culture of open and constructive feedback, ensuring staff have clear pathway for career development Contributing to staffing discussions as well as long-term strategic planning in conjunction with other senior leaders Helping to develop and maintain processes required for the effective operation of the research team (e.g., onboarding, training, templates etc.) Supporting staff to effectively communicate within and across teams, resolving conflicts tactfully, and stimulating morale Providing methodological/subject matter input to and signing off on proposals and presentation content Establishing trusted partnerships with clients and driving new business opportunities Identifying opportunities for growth and recommendations for hiring that aligns with business development Play an active role in counseling and mentoring junior team members within ZS; Demonstrate ability to quickly assimilate new knowledge. May require travel domestically and/or internationally including overnight stays Qualifications : Bachelor’s degree in a relevant discipline MSc in relevant discipline preferred, e.g. health economics, public policy, health policy, epidemiology, biostatistics, or public health, or science (biology/biochemistry etc.) Minimum 10 years of directly relevant experience in a similar industry / consulting environment Demonstrates expert understanding of the pharmaceutical industry and requirements for health technology assessment, evidenced by a track record of relevant publications Demonstrated experience with Health Economics and Outcomes Research (HEOR) with a particular emphasis on health Evidence Synthesis - e.g. SLRs, ITCs, Dossier Writing etc. Good understanding of relevant methodologies and statistics Ability to lead and manage teams Ability to work seamlessly and collaboratively with teammates across our global practice Excellent communication and interpersonal skills Expertise in communicating HEOR findings in various forms (e.g., peer-reviewed publication, abstracts and conference presentations, HTA dossiers, PowerPoint presentations) Perks & Benefits: ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth and professional development. Our robust skills development programs, multiple career progression options and internal mobility paths and collaborative culture empowers you to thrive as an individual and global team member. We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections. Travel: Travel is a requirement at ZS for client facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures. Considering applying? At ZS, we're building a diverse and inclusive company where people bring their passions to inspire life-changing impact and deliver better outcomes for all. We are most interested in finding the best candidate for the job and recognize the value that candidates with all backgrounds, including non-traditional ones, bring. If you are interested in joining us, we encourage you to apply even if you don't meet 100% of the requirements listed above. ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law. To Complete Your Application: Candidates must possess or be able to obtain work authorization for their intended country of employment.An on-line application, including a full set of transcripts (official or unofficial), is required to be considered. NO AGENCY CALLS, PLEASE. Find Out More At: www.zs.com
Posted 1 month ago
3.0 years
0 Lacs
Dimapur, Nagaland, India
On-site
The University of Hong Kong Apply now Ref.: 532532 Work type: Full-time Department: School of Public Health (22400) Categories: Executive / Technical / Support Hong Kong Assistant Project Manager (at the rank of Executive Officer) in the Division of Epidemiology and Biostatistics, School of Public Health (Ref.: 532532) (to commence on November 1, 2025, on a two-year fixed-term basis with contract-end gratuity and University contribution to a retirement benefits scheme, totalling up to 10% of basic salary, with the possibility of renewal subject to funding availability and satisfactory performance) Applicants should possess a good university degree with at least 3 years’ relevant experience in areas such as human resources, financial management, office management and research administration. Prior experience working across multiple tertiary institutions or research institutes is highly desirable. Candidates should demonstrate practical expertise in liaising with both public and private research funding bodies, including government agencies and large-scale philanthropic organizations at both local and international levels. A strong command of written and spoken English and Chinese, IT proficiency, and excellent interpersonal, communication and organization skills are required. The ideal candidates will be mature, meticulous and proactive, with a responsible and positive attitude. The appointee will be responsible for providing comprehensive administrative and secretarial support to the team, including but not limited to grant and award applications, contract research activities and multi-institutional projects. The role entails managing key operational aspects such as human capital, budgeting processes and other financial matters associated with the team and its projects. In addition, the appointee will assist in planning and coordinating a variety of academic and research-related events, such as seminars, conferences, forums, and short courses. He/She is also expected to collaborate effectively with research teams and administrative personnel at various levels, and to undertake other duties as assigned by supervisors. Shortlisted candidates will be invited to attend an interview and/or written test. A highly competitive salary commensurate with qualifications and experience will be offered, in addition to annual leave and medical benefits. The University only accepts online application for the above post. Applicants should apply online and upload an up-to-date C.V. Review of applications will start as soon as possible and continue until August 31, 2025 , or until the post is filled, whichever is earlier. Advertised: Jul 8, 2025 (HK Time) Applications close: Aug 31, 2025 (HK Time) Back to search results Apply now Whatsapp Facebook LinkedIn Email App
Posted 1 month ago
0 years
0 Lacs
Hyderabad, Telangana, India
On-site
JOB DESCRIPTION Biostatistician II statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. They prepare statistical sections of protocols, including sample size calculations, annotate shell data displays, and provide specifications for the structure, content, and algorithms of status and analysis datasets. They perform and oversee quality control (QC) of data displays with inferential statistics. Statisticians report to the Biostatistics Manager. QUALIFICATIONS FOR ESSENTIAL FUNCTIONS Develop, validate, and maintain SAS programs to create analysis datasets, tables, listings, and figures (TLFs) as specified in statistical analysis plans. Design and verify randomization codes to support clinical trial integrity. Prepare statistical sections of protocols, including sample size calculations, and annotate shell data displays. Provide specifications for the structure, content, and algorithms of status and analysis datasets. Perform and oversee quality control (QC) of data displays and analysis datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM). Conduct independent validation of datasets created by other programmers or statisticians. Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and programming/QC documentation. Manage electronic project directories to ensure organization and accessibility of deliverables. Mentor and guide junior programmers, providing training on SAS programming and clinical data standard
Posted 1 month ago
4.0 - 8.0 years
0 Lacs
Ahmedabad, Gujarat, India
Remote
Role Title: Programming Team Leader Reporting To: Associate Director, Statistical Programming Function: Data Management & Statistics Location:Remote Experience:4-8Years Purpose of the Role To ensure the accurate and timely execution of all statistical programming tasks by providing subject matter expertise and guiding a team of programmers. The role is responsible for generating statistical analyses from clinical databases, external data sources, and other relevant inputs in compliance with study protocols, statistical plans, regulatory guidelines, and internal processes to drive stakeholder satisfaction. Key Responsibilities & KPIs 1. Subject Matter Leadership Provide expert guidance on SDTM and ADaM development, ensuring alignment with the latest regulatory and industry standards (e.g., CDISC). Resolve complex issues related to dataset creation, transformation, and validation. Establish and maintain best practices for programming efficiency, reproducibility, and standardization. KPIs: Quality of programming deliverables (%) Stakeholder satisfaction (%) On-time task completion (%) Regulatory compliance (audit cases) Process improvements (#) Resolution of complex issues without escalation (#) Team training mandays (#) Voluntary attrition rate (%) 360° feedback results Training sessions conducted/attended (#) 2. Project Delivery Lead complex or high-priority programming tasks. Develop SAS programs for clinical trial outputs including TLFs, as per SAP. Conduct peer code reviews and optimize existing programs/macros for performance and efficiency. 3. Reporting Prepare comprehensive and timely management/statistical reports. Monitor data transfers during trials and address any issues proactively. Identify and escalate risks related to programming timelines and implement mitigation strategies. 4. Quality Assurance Establish and lead regular audits to ensure programming output and process quality. Execute data validation checks throughout the study lifecycle. Ensure accurate archiving of datasets, programs, and outputs post-study. 5. Policies, Processes & Procedures Maintain clear documentation of programming activities and dataset specifications. Ensure SOP adherence and correct any identified non-conformances. Implement new projects in line with department policies. Ensure compliance with Quality and Information Security Management Systems and applicable legal standards. 6. People Management Ensure technical and procedural training for all team members. Lead recruitment and foster team engagement and retention. Set team performance objectives, conduct appraisals, and provide feedback. Mentor team members for career growth and development. Recommend and support relevant training programs. Operating Network Internal: Department Heads External: None Role Requirements Education: Bachelor’s degree in Statistics, Mathematics, Biostatistics, Data Analysis, Data Science, or a related field. Master’s degree in the above fields is preferred. Experience: Minimum 8 years of SAS programming experience in clinical trials (CDISC standards), with at least 1–2 years of people management experience within a CRO, pharmaceutical, or related industry. Technical / Functional Competencies: SAS programming and statistical software SDTM/ADaM development Regulatory compliance (e.g., FDA, EMA) Project management Quality assurance Documentation and data interpretation Behavioral Competencies: Collaboration Communication Decision-making Problem-solving Coaching People management
Posted 1 month ago
8.0 - 12.0 years
0 Lacs
ahmedabad, gujarat
On-site
The Lead Biostatistician is a key member of the Department of Biostatistics & Programming, responsible for performing all Biostatistics tasks essential for clinical trial analysis and reporting. Collaborating closely with the Statistical Programming, Data Management, and Product Development departments, this position involves leading projects across studies or programs. As the primary contact with the sponsor for all biostatistics related activities on assigned projects, you will direct the activities of other biostatisticians to ensure timely completion of high-quality work. Your responsibilities include providing statistical support for clinical studies, developing and reviewing statistical analysis plans, monitoring statistical analysis programs, and collaborating with functional management to meet project deliverables and timelines. In addition, you will perform all SAS programming required for analysis and reporting, plan and execute SAS programs to analyze clinical trial data, and conduct quality control checks on assigned tasks. Your role also involves maintaining high productivity on projects, identifying and communicating resource and quality issues, resolving data interpretation and reporting issues, complying with regulatory requirements, and independently solving technical problems. To qualify for this position, you should hold a minimum of a master's degree in Statistics and have at least 8 years of experience as a Biostatistician and Statistical Programmer for all clinical trial phases. Proficiency in industry standards, CDISC data standards, ICH-GCP guidelines, medical terminology, and clinical trial methodologies is essential for success in this role.,
Posted 1 month ago
1.0 - 3.0 years
2 - 6 Lacs
Bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Associate Qualifications: BE/BTech/BCA Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience.The Clinical Reports Programming team is dedicated to developing and maintaining clinical reports for clinical trials. This involves utilizing PL/SQL, SQL, and Clinical SAS programming skills to create these reports. The team also integrates data from various sources such as EDC, Labs, and IRT. Ensuring that all reports comply with regulatory standards and guidelines is a crucial part of their work. They implement stringent quality assurance processes to uphold the highest levels of data integrity and report accuracy. Additionally, the team collaborates closely with clinical operations, biostatistics, and other departments to ensure the reports meet the needs of all stakeholders, facilitating informed decision-making based on accurate and timely data.Develop and review complex reports, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Oracle Procedural Language Extensions to SQL (PLSQL)Structured Query Language (SQL)Experience in writing programs using Clinical SASClinical Database ProgrammingClinical Data ManagementSAS ClinicalAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech,BCA
Posted 1 month ago
3.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Biostatistician II statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. They prepare statistical sections of protocols, including sample size calculations, annotate shell data displays, and provide specifications for the structure, content, and algorithms of status and analysis datasets. They perform and oversee quality control (QC) of data displays with inferential statistics. Statisticians report to the Biostatistics Manager. QUALIFICATIONS FOR ESSENTIAL FUNCTIONS Develop, validate, and maintain SAS programs to create analysis datasets, tables, listings, and figures (TLFs) as specified in statistical analysis plans. Design and verify randomization codes to support clinical trial integrity. Prepare statistical sections of protocols, including sample size calculations, and annotate shell data displays. Provide specifications for the structure, content, and algorithms of status and analysis datasets. Perform and oversee quality control (QC) of data displays and analysis datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM). Conduct independent validation of datasets created by other programmers or statisticians. Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and programming/QC documentation. Manage electronic project directories to ensure organization and accessibility of deliverables. Mentor and guide junior programmers, providing training on SAS programming and clinical data standard EDUCATION AND EXPERIENCE REQUIRED Master's degree in Statistics or equivalent combination of Education and Experience (e.g. a Bachelor’s degree and at least 3 years of industry experience as a biostatistician) required A minimum of 3 years of experience as a statistician is required for the Senior Statistician position; Proficient in SAS and similar clinical data analysis software
Posted 1 month ago
2.0 - 7.0 years
5 - 8 Lacs
Kerala
Work from Office
- Experience in computational biology and bioinformatics related areas is a must. - MS/PhD in Bioinformatics, Biostatistics, Mathematics, Computer Science, Computational biology or similar, with a strong publication record. - A strong understanding of statistical principles behind the current best practices in computational biology - Experience in computational biology and bioinformatics related areas is a must. - A strong understanding of statistical principles behind the current best practices in computational biology - Proven experience in drug discovery and development is essential preferably in industrial setting - Expertise in the use of a high-level programming language such as R, Python or Perl for complex data analysis. - Programming, web application programming, or relational database experience are pluses. - Proven expertise in defining and validating computational approaches to generate hypotheses using multivariate, Bayesian and machine learning approaches - Ability to generate in-silico experimental workflows and in-depth knowledge in proprietary and public biological databases, methods and tools.
Posted 1 month ago
6.0 - 8.0 years
0 Lacs
Telangana
On-site
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: The Senior Statistical Programming Lead is an experienced Statistical Programmer with advanced knowledge of statistical programming methods, languages and data structures and capabilities in leading analysis and reporting activities and programming teams in accordance to departmental processes and procedures. This position is accountable for the planning, oversight and delivery of statistical programming activities supporting one or more clinical projects, compounds and/or submissions generally of low-medium complexity/criticality. The Senior Statistical Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness and quality of deliverables and provide leadership, direction and technical and project specific guidance to programming teams. As an experienced Statistical Programmer this position applies advanced technical and problem-solving skills to complete programming activities of high complexity that may benefit multiple project teams. In addition, the Senior Statistical Programming Lead may contribute advanced knowledge and technical skills to Therapeutic Area or departmental innovation and process improvement projects. Principal Responsibilities As a Programming Lead; Accountable for Statistical Programming team delivery for one or more clinical projects generally of low to medium complexity, scope or criticality. Coordinates and supervises programming team activities and provides technical and project specific mentorship to programming team members to ensure quality and timely statistical programming deliverables in compliance with departmental processes and procedures. Develops detailed programming strategy, specifications and plans the programming deliverables for a one or more clinical projects. May act as a section lead of programming activities supporting a clinical program, compound or submission. Performs comprehensive review of, and provides input into, project requirements and documentation. Collaborates optimally with statistical programming and cross-functional team members and counterparts to achieve project goals. As applicable, coordinates statistical programming activities outsourced to third party vendors adopting appropriate processes and methods to ensure their performance meets the agreed upon scope, timelines, and quality. As an experienced Statistical Programmer; Designs and develops programs in support of sophisticated clinical data analysis and reporting activities. Applies technical and analytical expertise to develop and implement solutions for use on clinical projects leading to increased efficiency and quality. May contribute to or lead others in an area of expertise that results in solutions growing the efficiency and quality of deliverables across multiple projects. May play the role of a Therapeutic/Disease Area Expert contributing to standards strategy and definition and providing expertise for a specific Therapeutic/Disease area across value streams. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Principal Relationships Reports into people manager position within the functional area. Accountable to the Statistical Programming Portfolio Lead for assigned programming activities and responsibilities. Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Statistical Programmers, peer groups within the function, Data Management, Regulatory Medical Writing. Functional contacts within Janssen (as collaborator or peer) include but are not limited to Clinical Trial Lead, Quantitative Sciences, Biostatisticians, Regulatory, Clinical - Primary interfaces within clinical project (trial), program, and submission teams. External contacts include but are not limited to external partners including CROs. Qualifications - External Bachelor's degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth). Approximately 6-8 years programming experience with growing responsibility, preferably in a pharmaceutical/clinical trial environment. Advanced knowledge of relevant statistical programming languages including SAS (required), other relevant programming languages (e.g. R, Python etc. preferred), and data structures. Proven experience planning and coordinating programming activities and leading teams. Proven experience working with cross functional stakeholder and teams. Solid understanding of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Basic project management skills. Demonstrated written and verbal communication skills. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Posted 1 month ago
5.0 years
0 Lacs
India
On-site
Description Sr Biostatistician 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 Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR. Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required. May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report. Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis. Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications. Implements company objectives, and create alternative solutions to address business and operational challenges. Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalate to management. Provides statistical programming support as needed. May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician. May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness. Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business. Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. Coaches and mentors other Biostatistics staff. Performs other work-related duties as assigned. Minimal travel may be required. Qualifications Graduate degree in biostatistics or related discipline. Moderate experience in clinical trials or an equivalent combination of education and experience. Proficiency in programming. Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts. Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR. 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. http://www.syneoshealth.com 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.
Posted 2 months ago
6.0 years
3 - 6 Lacs
Hyderābād
On-site
About the job Our Team: Sanofi Global Hub 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 Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: The Senior Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Global Hub biostatistics and programming personnel to implement (Develop and/or QC) statistical analysis plans(SAP), programming specifications for analysis datasets and provide QC’d data packages including tables, figures, and listings for use in publications (i.e. abstracts, posters, oral, presentations, and manuscripts and ad-hoc data analysis requests) and to investigate the natural history of a TA diseases and long-term treatment outcomes of observational data using clinical trials and / or Registries as applicable) .The Senior Biostatistician will ensure SOPs are followed and timelines and quality metrics are met. People : Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product – with an objective to develop statistical data outputs. Performance / Process: 1) Conduct appropriate post-hoc or ad-hoc statistical analyses of clinical trial data and / or registry (i.e., Observational) data. 2) Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS. 3) Produce well documented data packages that include tables, listings, and figures. 4) Work closely with the Lead Biostatistician and Lead Programmer to develop and implement project QC plans and timelines. 5) Review appropriate biomedical and clinical research literature related to assigned project(s). Customer: Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables About you Experience : Master's degree 6 years (M.Sc.) of experience required /Ph.D. in biostatistics or statistics or epidemiology and 3 years. Soft skills : Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, High proficiency in statistical methods used in the pharmaceutical industry, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines. Technical skills : Advance SAS programming skills, SDTM & ADaM (CDISC) and other statistical computing software skills in a clinical data environment across multiple therapeutic areas. Education : Master of Science degree or equivalent in Statistics/ Ph.D. in biostatistics or statistics or epidemiology. Languages : Excellent English language knowledge – written and spoken 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!
Posted 2 months ago
8.0 years
0 Lacs
India
On-site
Description Pr Statistical Programmer(SDTM + ADAM + TLF) 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 standardoperation 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 Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Require 8+ years of experience in Clinical SAS Programming, Base SAS, Advance SAS. Must have strong experience in SDTM, ADAM & TLF for Safety & efficacy data both. Require eSub experience. Must have study lead experience 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. http://www.syneoshealth.com 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.
Posted 2 months ago
8.0 years
0 Lacs
India
On-site
Description Pr Statistical Programmer(SDTM+ ADAM +TLF) 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 standardoperation 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 Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Require 8+ years of experience in Clinical SAS Programming, Base SAS, Advance SAS. Must have strong experience in SDTM, ADAM & TLF for Safety & efficacy data both. Require eSub experience. Must have study lead experience 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. http://www.syneoshealth.com 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.
Posted 2 months ago
5.0 years
0 Lacs
India
On-site
Description Principal Stat 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 definesall 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 programmingdeliverables. 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 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. http://www.syneoshealth.com 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.
Posted 2 months ago
1.0 - 3.0 years
2 - 6 Lacs
Bengaluru
Work from Office
Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Associate Qualifications: BE/BTech/Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience.The Clinical Database Management team is committed to developing and maintaining databases for clinical trials, which includes creating Case Report Forms (CRFs) and developing Edit and Validation Checks using programming skills like C# and PL/SQL. They also support data integration from various external sources such as labs and Interactive Response Technology (IRT). The team ensures compliance with regulatory standards and guidelines, maintaining high levels of data quality and security. Additionally, they continuously seek to improve database processes and tools by leveraging the latest technologies and best practices to enhance efficiency and accuracyThe Clinical Reports Programming team is dedicated to developing and maintaining clinical reports for clinical trials. This involves utilizing PL/SQL, SQL, and Clinical SAS programming skills to create these reports. The team also integrates data from various sources such as EDC, Labs, and IRT. Ensuring that all reports comply with regulatory standards and guidelines is a crucial part of their work. They implement stringent quality assurance processes to uphold the highest levels of data integrity and report accuracy. Additionally, the team collaborates closely with clinical operations, biostatistics, and other departments to ensure the reports meet the needs of all stakeholders, facilitating informed decision-making based on accurate and timely data. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningCandidates who have completed B.Tech or B.E in Computer science in 2024 & 2025 (if all semester s results are available) Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech,Masters in actuarial science
Posted 2 months ago
0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
Position: Clinical Scientist - Artificial Intelligence in Healthcare Job Location: Bangalore About Anumana: https://anumana.ai/ Anumana is a new AI-driven health technology company from nference, developing and delivering ECG algorithms enabling early diagnosis and intervention. Qualifications: DM/DNB Cardiology or MD/DNB (Internal Medicine) or MD/DNB (Anesthesia) or MD/DNB/Fellow (Critical care/Intensive Care) or MS/MCH(Surgical fields) or any other masters (MD/DNB/Diploma from clinical fields). MBBS with a bachelor/master/PhD in a technical domain including MMST, MTech (Biomedical engineering or domain related to data science), or fellowship in a domain related to healthcare research Exceptional candidates from other streams of medicine(non-clinical subjects like pharmacology, Community Medicine, etc) will also be considered. Requirements: Strong understanding of the nuances of medicine pertaining to patient care (a broader understanding of Cardiology/ Internal Medicine/ ICU is preferred) Basic interpretation of ECGs Strong interest in research and product development Basic understanding of relational databases (Optional) Basic understanding of Python and SQL (Optional) Basic understanding of biostatistics (Optional) Job Description: Working in close proximity with lead clinicians(both India Based and US-based), software and data science team in developing Artificial Intelligence based models on ECG inputs Leveraging clinical experience to create pathways towards making AI models for clinical application. Designing cohorts for training/validation of various AI models and performing statistically sound analyses with them Benefits: Work with some of the brilliant minds of the world solving exciting real-world problems through Artificial Intelligence, Machine Learning, analytics and insights through triangulating unstructured and structured information from the biomedical literature as well as from large-scale molecular and real-world datasets. Our benefits package includes the best of what leading organizations provide, such as stock options, paid time off, healthcare insurance, gym/broadband reimbursement.
Posted 2 months ago
1.0 years
0 Lacs
Dimapur, Nagaland, India
On-site
The University of Hong Kong Apply now Ref.: 532533 Work type: Full-time Department: School of Public Health (22400) Categories: Research Staff Hong Kong Senior Research Assistant in the Division of Epidemiology and Biostatistics, School of Public Health (Ref.: 532533) , to commence on 1 November 2025 or thereafter, on a one-year temporary term contract, with the possibility of renewal subject to satisfactory performance and funding availability. Applicants Should Possess a Master's degree or above in Computer Science, Computational Linguistics, Machine Learning, Natural Language Processing (NLP), Statistics, or a related discipline; strong programming skills in Python, R, Java, or C/C++ are essential, along with at least 1 year’s post-qualification experience in using relevant libraries and frameworks (TensorFlow, PyTorch, scikit-learn) and environments (e.g. Ubuntu, BRAT); extensive experience with deep learning architectures, machine learning techniques, statistical modelling, and prompt engineering, applied to healthcare-oriented NLP tasks - including text classification, named entity recognition, text generation; and a strong track record of working with EHR data and developing NLP applications for lupus-related research. Responsibilities The appointee will contribute to research projects at the intersection of natural language processing (NLP) and clinical medicine. Key responsibilities include: applying regex and related techniques for data deanonymization and text pre-processing; selecting diverse, representative samples from sparse populations; designing and developing language model-based systems for assisting annotators in annotating lupus-related clinical features; working with electronic health records (EHRs) and other clinical documents to extract meaningful information from unstructured text (e.g. clinical notes, discharge summaries); implementing, evaluating and deploying NLP-based scoring systems for real-world clinical notes for the lupus disease; prompting and training large language models (LLMs) through supervised fine-tuning or reinforcement learning techniques; preparing project plans, IRB applications, and supporting documentations; coordinating team communication, organizing meetings, and recruiting and managing annotators; and collaborating with multidisciplinary teams, including clinicians, data scientists, software engineers, and healthcare stakeholders, to translate clinical and research needs into technical solutions. Enquiries about the duties of the post should be sent to Ms Audrey Ho at audreyh@hku.hk. Information about the School can be obtained at https://sph.hku.hk/. A highly competitive salary commensurate with qualifications and experience will be offered, in addition to annual leave and medical benefits. The University only accepts online application for the above post. Applicants should apply online and upload an up-to-date CV. Review of applications will start as soon as possible and continue until 3 October 2025 , or until the post is filled, whichever is earlier. Advertised: Jul 4, 2025 (HK Time) Applications close: Oct 3, 2025 (HK Time) Back to search results Apply now Whatsapp Facebook LinkedIn Email App
Posted 2 months ago
5.0 years
0 Lacs
Navi Mumbai, Maharashtra, India
On-site
Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Statistical Programming Manager to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities Provide support to project teams on programming matters; Manage programming staff, coordinate task assignments and review activities/progress to ensure high quality delivery; Provide leadership and training for the Programming group; Ensure all projects within the team meet objectives and timelines; and Lead the development of Programming standards, applications and processes to maximize efficiencies. Qualifications Bachelor/Master degree in statistics, mathematics, health informatics, computer science, or related field; Proficiency in SAS programming skills; 5 years of clinical programming experience; Strong communication skills and coordination skills; and Good leadership skills. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What To Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
Posted 2 months ago
15.0 years
0 Lacs
Hyderabad, Telangana, India
Remote
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Position Summary The Senior Manager, Senior Solution Engineer, Drug Development Information Technology (DDIT) will be part of the product team committed to bridge the gap between technology and business needs within the Clinical Data Ecosystem (CDE) that primarily delivers technology strategy and solutions for clinical trial execution, Global Biostatistics and Data Sciences, Clinical Data Management (Clinical Analytics, Site Selection, Feasibility, Real Word Evidence) The role is based out of our Hyderabad office, and is part of the Research and Development (R&D) BI&T data team that delivers data and analytics capabilities for across DD. You will be specifically supporting our Clinical Data Filing and Sharing (CDFS) Product line. This is a critical role that supports systems necessary for BMS' direct value change; regulated analysis and reporting for every trial in BMS Desired Candidate Characteristics:" Have a strong commitment to a career in technology with a passion for healthcare" Ability to understand the needs of the business and commitment to deliver the best user experience and adoption" Able to collaborate across multiple teams"" Demonstrated leadership experience Excellent communication skills" Innovative and inquisitive nature to ask questions, offer bold ideas and challenge the status quo" Agility to learn new tools and processes" As the candidate grows in their role, they will get additional training and there is opportunity to expand responsibilities and exposure to additional areas withing Drug Development. This includes working with Data Product Leads, providing input and innovation opportunities to modernize with cutting edge technologies (Agentic AI, advanced automation, visualization and application development techniques). Key Responsibilities Architect and lead the evolution of the Statistical Computing Environment (SCE) platform to support modern clinical trial requirements Partner with data management and statistical programming leads to support seamless integration of data pipelines and metadata-driven standards Lead the development of automated workflows for clinical data ingestion, transformation, analysis, and reporting within the SCE. Drive process automation and efficiency initiatives in data preparation and statistical programming workflows Develop and implement solutions to enhance system performance, stability and security Act as a subject matter expert for AWS SAS implementations and integration with clinical systems. Lead the implementation of cloud-based infrastructure using AWS EC2, Auto Scaling, CloudWatch, and AWS related packages Provide architectural guidance and oversight for CDISC SDTM/ADaM data standards and eCTD regulatory submissions. Collaborate with cross-functional teams to identify product improvements and enhancements. Administer production environment and diagnose & resolve technical issues in a timely manner, documenting solutions for future reference. Coordinate with vendors, suppliers, and contractors to ensure the timely delivery of products and services Serve as a technical mentor for development and operations teams supporting SCE solutions. Analyze business challenges and identify areas for improvement through technology solutions. Ensure regulatory and security compliance through proper governance and access controls. Provide guidance to the resources supporting projects, enhancements, and operations. Stay up to date with the latest technology trends and industry best practices. Qualifications & Experience: Master's or bachelor's degree in computer science, information technology, or related field preferred. 15 + years of experience in software development and engineering, clinical development or data science field 8-10 years of hands-on experience working on implementing and operation of different type of Statistical Clinical Environment (SCE) with Life Sciences and Healthcare business vertical. Strong experience with SAS in an AWS-hosted environment including EC2, S3, IAM, Glue, Athena, and Lambda Hands-on development experience managing and delivering data solutions with AWS data, analytics, AI technologies such as AWS Glue, Redshift, RDS (PostgreSQL), S3, Athena, Lambda, Databricks, Business Intelligence and Visualization tools etc. Experience with R, Python, or other programming languages for data analysis or automation. Experience in shell/ Python scripting and Linux automation for operational monitoring and alerting across the environment Familiarity with cloud DevOps practices, infrastructure-as-code (e.g., CloudFormation, Terraform). Expertise in SAS Grid architecture, grid node orchestration, and job lifecycle management. Strong working knowledge of SASGSUB, job submission parameters, and performance tuning. Understanding of submission readiness and Health Authority requirements for data traceability and transparency. Excellent communication, collaboration and interpersonal skills to interact with diverse stakeholders. Ability to work both independently and collaboratively in a team-oriented environment. Comfortable working in a fast-paced environment with minimal oversight. Prior experience working in an Agile based environment. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Responsibilities BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 2 months ago
15.0 years
0 Lacs
Hyderābād
Remote
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Position Summary: The Senior Manager, Senior Solution Engineer, Drug Development Information Technology (DDIT) will be part of the product team committed to bridge the gap between technology and business needs within the Clinical Data Ecosystem (CDE) that primarily delivers technology strategy and solutions for clinical trial execution, Global Biostatistics and Data Sciences, Clinical Data Management (Clinical Analytics, Site Selection, Feasibility, Real Word Evidence) The role is based out of our Hyderabad office, and is part of the Research and Development (R&D) BI&T data team that delivers data and analytics capabilities for across DD. You will be specifically supporting our Clinical Data Filing and Sharing (CDFS) Product line. This is a critical role that supports systems necessary for BMS' direct value change; regulated analysis and reporting for every trial in BMS Desired Candidate Characteristics:" Have a strong commitment to a career in technology with a passion for healthcare" Ability to understand the needs of the business and commitment to deliver the best user experience and adoption" Able to collaborate across multiple teams"" Demonstrated leadership experience Excellent communication skills" Innovative and inquisitive nature to ask questions, offer bold ideas and challenge the status quo" Agility to learn new tools and processes" As the candidate grows in their role, they will get additional training and there is opportunity to expand responsibilities and exposure to additional areas withing Drug Development. This includes working with Data Product Leads, providing input and innovation opportunities to modernize with cutting edge technologies (Agentic AI, advanced automation, visualization and application development techniques). Key Responsibilities: Architect and lead the evolution of the Statistical Computing Environment (SCE) platform to support modern clinical trial requirements Partner with data management and statistical programming leads to support seamless integration of data pipelines and metadata-driven standards Lead the development of automated workflows for clinical data ingestion, transformation, analysis, and reporting within the SCE. Drive process automation and efficiency initiatives in data preparation and statistical programming workflows Develop and implement solutions to enhance system performance, stability and security Act as a subject matter expert for AWS SAS implementations and integration with clinical systems. Lead the implementation of cloud-based infrastructure using AWS EC2, Auto Scaling, CloudWatch, and AWS related packages Provide architectural guidance and oversight for CDISC SDTM/ADaM data standards and eCTD regulatory submissions. Collaborate with cross-functional teams to identify product improvements and enhancements. Administer production environment and diagnose & resolve technical issues in a timely manner, documenting solutions for future reference. Coordinate with vendors, suppliers, and contractors to ensure the timely delivery of products and services Serve as a technical mentor for development and operations teams supporting SCE solutions. Analyze business challenges and identify areas for improvement through technology solutions. Ensure regulatory and security compliance through proper governance and access controls. Provide guidance to the resources supporting projects, enhancements, and operations. Stay up to date with the latest technology trends and industry best practices. Qualifications & Experience: Master's or bachelor's degree in computer science, information technology, or related field preferred. 15 + years of experience in software development and engineering, clinical development or data science field 8-10 years of hands-on experience working on implementing and operation of different type of Statistical Clinical Environment (SCE) with Life Sciences and Healthcare business vertical. Strong experience with SAS in an AWS-hosted environment including EC2, S3, IAM, Glue, Athena, and Lambda Hands-on development experience managing and delivering data solutions with AWS data, analytics, AI technologies such as AWS Glue, Redshift, RDS (PostgreSQL), S3, Athena, Lambda, Databricks, Business Intelligence and Visualization tools etc. Experience with R, Python, or other programming languages for data analysis or automation. Experience in shell/ Python scripting and Linux automation for operational monitoring and alerting across the environment Familiarity with cloud DevOps practices, infrastructure-as-code (e.g., CloudFormation, Terraform). Expertise in SAS Grid architecture, grid node orchestration, and job lifecycle management. Strong working knowledge of SASGSUB, job submission parameters, and performance tuning. Understanding of submission readiness and Health Authority requirements for data traceability and transparency. Excellent communication, collaboration and interpersonal skills to interact with diverse stakeholders. Ability to work both independently and collaboratively in a team-oriented environment. Comfortable working in a fast-paced environment with minimal oversight. Prior experience working in an Agile based environment. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 2 months ago
0 years
0 Lacs
Bengaluru
On-site
Site Name: Bengaluru Luxor North Tower Posted Date: Jul 4 2025 Key Responsibilities Leads the development of business requirements for data curation through collaboration with relevant stakeholders within and outside RWDMA. Maintain strong connections with analytical groups and R&D Data Platform teams to ensure seamless data integration and usage. Develop and implement the vision and strategy for the design of the framework to consistently curate (e.g. pre-process, harmonize, wrangle, contextualize and/or anonymize) data in the right manner to the right people to drive value in alignment with Disease Area Strategies and other key R&D priority areas. Partner strongly with the Disease Area Heads in R&D and their teams to ensure the provisioning of required and high-quality curated datasets to deliver their disease and/or asset-level data strategy and modelling plans. Enable bi-directional transparency between Business and R&D Tech to ensure alignment of strategies, achieve business objectives/outcomes, and maintain service levels in line with business needs, while prioritizing data privacy and security. Ensure all datasets meet analysis-ready and privacy requirements by performing necessary data curation activities (e.g. pre-process, contextualize and/or anonymize). Ensure that datasets are processed to meet conditions mentioned in the approved data re-use request (e.g., remove subjects from countries that do not allow re-use). Write clean, readable code. Ensure that deliverables are appropriately quality controlled, documented, and when required, can be handed over to R&D Tech team for production pipeline implementation. Transforming raw healthcare data into products that can be used to catalyze the work of the wider RWDMA and Biostatistics teams and be leveraged by our diverse group of stakeholders to generate insights. Ensuring data quality, integrity, and security across various data sources. Supporting data-driven decision-making processes that enhance patient outcomes and operational efficiencies. Education Requirements Advanced degree (Master's or Ph.D.) in Life Sciences, Epidemiology, Biostatistics, Public Health, Computer Sciences, Mathematics, Statistics or a related field with applicable experience. Job Related Experience Expertise to translate business needs into technical data requirements and processes. Proven track record of leading and managing high-performing data engineering teams Experience in data engineering and curation, with majority of experience on real-world data in the healthcare or pharmaceutical industry. Proven ability to handle and process large datasets efficiently, ensuring data privacy. Proficiency in handling structured, semi-structured, and unstructured data while ensuring data privacy. Understanding of data governance principles and practices with a focus on data privacy. Innovative mindset and willingness to challenge status quo, solution-oriented mindset Fluent in written and spoken English to effectively communicate and able to articulate complex concepts to diverse audiences Experience of working in global matrix environment and managing stakeholders effectively Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.
Posted 2 months ago
0 years
5 - 9 Lacs
India
On-site
Key Responsibilities: Data Collection & Validation: Review and clean data from clinical trials, ensuring compliance with regulatory standards. Database Management: Oversee the setup, maintenance, and quality control of clinical trial databases. Data Review: Ensure data is accurate, complete, and meets protocol requirements. Collaboration: Work closely with clinical operations, biostatistics, and project management teams. Documentation & Reporting: Maintain proper documentation and provide regular updates on data status. Compliance: Ensure adherence to Good Clinical Practice (GCP), FDA regulations, and other industry standards. Job Type: Full-time Pay: ₹500,000.00 - ₹950,000.00 per year Benefits: Health insurance Internet reimbursement Schedule: Day shift Work Location: On the road
Posted 2 months ago
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