Statistical programmer
2 weeks ago
JOB SUMMARY Responsible for providing statistical programming support for the Biostatistics and Data Management functions for all clinical trials and regulatory submissions. Works closely with Biostatisticians and Data Managers to support creating SAS programs for independently validating tables, listings, and figures produced by programming vendors, for ad-hoc analyses, and to assist with data cleaning and query generation. Independently produces selected SDTMs/ADa M/TFLs for analysis preparation and for validation. Serves as a contact for programming activities being performed at assigned CROs. ESSENTIAL DUTIES AND RESPONSIBILITIES: Provides SAS programming support to all clinical studies. Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables. Provide statistical programming support for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (e CTD). Provides primary programming and QC support for any internally produced outputs. Reviews and approves SAS programming instructions and CDISC/ADa M specifications. Performs statistical analysis and simulations using SAS to support clinical trial design and data interpretation. Reviews and provides input on e CRF design, external vendor data specifications, edit checks, and other Data Management related documents to ensure appropriate data collection for statistical programming. Works closely with biostatisticians and data managers to identify data issues and generate queries that may impact statistical analysis and/or programming. Works closely with biostatisticians and other functions (Pharmacovigilance, Clinical Development, etc.) to support data review for internal stakeholders. Assists with ensuring consistency across programming methods in similar studies within a program. JOB QUALIFICATIONS Education, Certifications, Experience: Bachelor’s Degree or Master’s degree or higher in statistics, biostatistics, or other closely related discipline with a minimum of 5-8 years of relevant experience in the pharmaceutical/biotechnology industry Experience in applying clinical trial and statistical methodology to a variety of studies and indications across various phases of clinical development Knowledge, Skills and Abilities: Knowledge of pharmaceutical and regulatory requirements, procedures, and policies. Experience with BLA or NDA/s NDA submissions is a plus. Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements. In depth knowledge of CDISC and ADa M data set structures and requirements Proficiency with SAS programming skills to including knowledge of SAS ODS graphical procedures such as PROC SGPLOT and the graphics template language (GTL) Knowledge of all aspects of clinical drug development (Phase 1-4) Experience working with a CRO partner. Excellent computer skills; strong verbal and written communication skills Ability to work well in a team environment as a contributor. Open, engaging, and transparent work style Ability to competently manage multiple competing priorities, switching priorities quickly as needs change. Must be comfortable working in a very fast-paced environment
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Statistical Programmer
6 months ago
India CosMic IT Full timeFull Time - India - Posted 11 months ago - Applications have closed - CosMicIT **CosMic IT** - Find Your Dream Job Here_ Hello #Everyone, We at #CosMicIT are looking for #Statistical Programmer Language: #English Locations: #India Summary: R/Python exp/knowledge, knowledge/exp of eCRF & SQL. 1. 1 to 4 years of experience in programming related...
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Senior Statistical Programmer
2 hours ago
India Clinical Pharma Full timeHiring Senior Statistical Programmers in India! Are you a skilled Statistical Programmer with expertise in Python, PySpark, SAS, and SDTM ? Join leading global companies to shape the future of data science in clinical trials! Role : Senior Statistical Programmer Location : Remote & On-Site Opportunities Across India Skills : Proficiency in SDTM ...
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Statistical Programmer
7 months ago
India Cytel, India Full timeCytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where...
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Statistical Programmer
2 weeks ago
India Trigent Software - Professional Services Full timeWe are seeking experienced Statistical Programmers to join our team! If you have the following experience, we want to hear from you: Experience Requirements : SDTM Specification Creation : 5+ years SDTM Dataset Creation and Validation : 6+ years SDRG : 3+ years Tables and Listings : 3+ years CRF Annotation : 4+ years XML : 4+...
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India K3-Innovations, Inc. Full timeJob OverviewThe Statistical Programmer at K3-Innovations, Inc. will provide support for statistical programming activities across various clinical trials and regulatory submissions. The ideal candidate will have a strong background in statistics and biostatistics, as well as experience working with pharmaceutical companies.
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Clinical Pharma | Senior Statistical Programmer
14 hours ago
india Clinical Pharma Full time🌟 Hiring Senior Statistical Programmers in India! 🌟Are you a skilled Statistical Programmer with expertise in Python, PySpark, SAS, and SDTM? Join leading global companies to shape the future of data science in clinical trials!💼 Role: Senior Statistical Programmer📍 Location: Remote & On-Site Opportunities Across India💡 Skills:Proficiency in...
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Senior Statistical Programmer
4 weeks ago
India IQVIA India Full timeJob Title : Senior Statistical Programmer Experience : 7+ years Location : Across INDIA Job Overview At a team/site/staff level, provide advanced technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving the...
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Senior Statistical Programmer
4 weeks ago
India IQVIA India Full timeJob Title : Senior Statistical ProgrammerExperience : 7+ yearsLocation : Across INDIAJob OverviewAt a team/site/staff level, provide advanced technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of...
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Senior Statistical Programmer
4 weeks ago
India IQVIA India Full timeJob Title : Senior Statistical Programmer Experience : 7+ years Location : Across INDIA Job Overview At a team/site/staff level, provide advanced technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving the...
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Senior Statistical Programmer
4 weeks ago
India IQVIA India Full timeJob Title : Senior Statistical Programmer Experience : 7+ years Location : Across INDIA Job Overview At a team/site/staff level, provide advanced technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving the full...
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Statistical Programmer Ii
6 months ago
India ICON plc Full timeICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What you will be doing**: - Responsible for planning, managing and execution of statistical...
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Manager Statistical Programmer
1 month ago
India Veramed Full timeAs a mid-size Contract Research Organisation (CRO), Veramed prides itself on two key areas: providing the highest quality statistics and programming consultancy for its clients, and giving its employees an industry leading working environment, support and development for growth. We don’t believe in a universal model for Programmers, which is why you’ll...
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Statistical Programmer
3 months ago
India Excelya Full time**Responsibilities**: - To be the reference point in India, to be able to recruit, train and organize the team. - Responsible for providing SAS programming support in terms of SDTM and ADaM datasets and tables and listings (TFLS). - Support the creation or validation of SDTM, ADaM Specification and annotated CRF based on CDISC standards. - Skilful in SAS...
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Statistical Programmer
6 months ago
India SureEvents Full time**Job Code**:SE / GFS / 00623**Job Location**:Multiple Cities / Hybrid / Remote**Experience**:5 -10 years**Requirements**: - Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required. - At least 3 years programming experience in industry recommended. - Demonstrated proficiency in using SAS, R or other...
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Trigent Software
2 weeks ago
india Trigent Software - Professional Services Full timeWe are seeking experienced Statistical Programmers to join our team! If you have the following experience, we want to hear from you:
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Veramed | Manager Statistical Programmer
1 month ago
india Veramed Full timeAs a mid-size Contract Research Organisation (CRO), Veramed prides itself on two key areas: providing the highest quality statistics and programming consultancy for its clients, and giving its employees an industry leading working environment, support and development for growth. We don’t believe in a universal model for Programmers, which is why you’ll...
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Lead Statistical Programmer
2 weeks ago
India K3-Innovations, Inc. Full timeAs a highly skilled statistical programmer, you will play a crucial role in supporting the Biostatistics and Data Management functions for all clinical trials and regulatory submissions at K3-Innovations, Inc.About the RoleYou will work closely with biostatisticians and data managers to provide SAS programming support for creating tables, listings, and...
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Lead statistical programmer
2 weeks ago
India K3-Innovations, Inc. Full timeResponsible for providing statistical programming support for the Biostatistics and Data Management functions for all clinical trials and regulatory submissions. Works closely with Biostatisticians and Data Managers to support creating SAS programs for independently validating tables, listings, and figures produced by programming vendors, for ad-hoc...
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Sr statistical programmer
2 weeks ago
India K3-Innovations, Inc. Full timeJOB SUMMARY: Responsible for providing statistical programming support for the Biostatistics and Data Management functions for all clinical trials and regulatory submissions. Works closely with Biostatisticians and Data Managers to support creating SAS programs for independently validating tables, listings, and figures produced by programming vendors, for...
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india IQVIA India Full timeJob Title : Senior Statistical Programmer Experience : 7+ years Location : Across INDIA Job Overview At a team/site/staff level, provide advanced technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving the full...