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9.0 - 12.0 years
30 - 35 Lacs
hyderabad, chennai, bengaluru
Hybrid
ROLES and RESPONSIBILITIES: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Review Specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages [Define.xml], and Reviewers guide [RGs] for all the deliverables Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shells Setup the folder structure for the assigned study as per the SOP Forecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projects Provide the study status to the Project Manager/Client periodically Identify, communicate, and manage study...
Posted 3 weeks ago
5.0 - 8.0 years
15 - 30 Lacs
hyderabad, chennai, bengaluru
Hybrid
ROLES and RESPONSIBILITIES: Perform statistical programming review of case report forms (CRFs), annotated CRFs, database structures, statistical analysis plan (SAP) project documentation such as Statistical Analysis Plan (SAP), mock shells, programming specifications and annotated CRFs Provide the statistical programming support for assigned studies, in both production and QC of analysis dataset specifications, analysis datasets, statistical analysis tables, data listings, figures, and statistical appendices Provide the status of assigned tasks to Study Lead Programmer and Project Manager Identify, communicate, and manage study-based risks and issues Maintain supporting documentation for stu...
Posted 3 weeks ago
7.0 - 12.0 years
22 - 30 Lacs
kerala
Hybrid
Position Summary The Principal Statistical Programmer is a key member of the Development Operations, Statistical Programming Team. The Principal Statistical Programmer will program routine and customized data displays, (including listings, tables, and graphics) in accordance with approved Statistical Analysis Plan and shell displays. Additionally, the Principal Statistical Programmer will write CDISC compliant SDTM specifications and program CDISC compliant SDTM and ADaM domains. Code is to be written using SAS, SAS procedures, or standardized macros. The Principal Programmer will assume a leadership role on multiple complex projects, direct and/or mentor programmers at more junior levels an...
Posted 3 weeks ago
7.0 - 12.0 years
30 - 45 Lacs
bengaluru
Remote
Purpose The role of the Principal Programmer is to provide programming support to the statistics and programming department across a range of projects, clients and therapeutic areas. The Principal Programmer may also perform a supervisory role (e.g. line management and/or project management). Key Responsibilities Supporting with CDISC implementation of studies with Real world data QC of SDTM/ADaM datasets as required Review the aCRF, Specs, relevant documentation like SDRG/ADRG, Define.xml as relevant Expertise working across different disease areas like Oncology, Vaccines, Respiratory etc Guide Real World Programmers on NIS with CDISC expectations Technical: Perform review of clinical trial...
Posted 3 weeks ago
6.0 - 11.0 years
20 - 35 Lacs
remote, india
On-site
Key Responsibilities & Requirements: 5+ years of hands-on experience in SDTM, ADaM, and TLF across various therapeutic areas and clinical trial phases. Strong experience in creating and delivering ADaM datasets and TLFs for clinical trial studies. Proficient in creating and working with utility macros to support programming tasks. Skilled in creating specifications for datasets and deliverables. Familiarity with CDISC standards , including CDASH, SDTM, and ADaM . Ability to work independently as well as collaboratively within a team environment. Open to learning new tools and technologies and sharing knowledge with team members. Strong communication skills written, verbal, interpersonal, and...
Posted 3 weeks ago
5.0 - 10.0 years
15 - 30 Lacs
hyderabad
Hybrid
Role & responsibilities Develop and maintain data formatter repository structure. Develop data formatter for data transfer per project specific data transfer plan (DTP). Develop data processing tools for data ingestion and data export. Develop test scripts to ensure correct functionality of the developed data management tools. Document code, procedures, tests used for data QC, clinical data integration, and data transfer operations. Develop data pipelines for integration with internal and external systems. Develop Data Transfer Plans in collaboration with the Software Engineering teams. Develop in a team environment with source code management. Performs other departmental and study-related a...
Posted 3 weeks ago
3.0 - 8.0 years
7 - 12 Lacs
hyderabad
Work from Office
About The Role : We are seeking a detail-oriented and experienced Biostatistician II to support statistical analyses for clinical research studies. This role involves developing and validating SAS programs, preparing statistical documentation, and ensuring compliance with regulatory standards such as CDISC. The ideal candidate will have a strong foundation in statistics, clinical trial methodology, and statistical programming. Key Responsibilities: Develop, validate, and maintain SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) as per statistical analysis plans. Design and verify randomization codes to ensure clinical trial integrity. Prepare statistical secti...
Posted 3 weeks ago
6.0 - 8.0 years
0 Lacs
bengaluru, karnataka, india
On-site
Biostatistician cum Statistical Programmer Job Description Performs biostatistical and SAS programming activities for given clinical trials involving Novel, Biosimilar and PMS studies. As a Biostatistician cum Statistical Programmer youll work on a variety of projects, while collaborating with our cross-functional team of experts. Youll be able to develop your statistical skills, gain exposure to multiple therapeutic areas. Youll also contribute to research design and analytical strategies, provide input into protocols, Statistical Methodology and develop and review statistical analysis plans. As a Statistical Programmer, you will leverage your SAS programming skills to support Phase I-IV cl...
Posted 3 weeks ago
7.0 - 12.0 years
16 - 31 Lacs
bengaluru
Remote
. Roles and Responsibility • Perform, plan and co-ordinate the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing summaries and (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients. May perform and plan the programming of database quality control checks. • Program and plan the integration of databases from multiple studies or sources. • Develop and co-ordinate programming documentation including plans and specifications, as appropriate, for complex studies. • Provide advanced technical expertise in conjunction with i...
Posted 3 weeks ago
2.0 - 7.0 years
3 - 15 Lacs
remote, india
On-site
Job Responsibilities / Requirements Strong end-to-end programming experience, including SDTM, ADaM, and TLF development. Minimum 2 years of relevant experience in project and people management, including oversight of project metrics. Lead and manage a team of 20+ members. Hands-on experience in safety and efficacy programming, including writing specifications for SDTM and ADaM datasets. Experience across Clinical Phases I, II, III & IV. Therapeutic Areas: Any. Proficiency in R or Python is a plus.
Posted 3 weeks ago
8.0 - 12.0 years
3 - 15 Lacs
remote, india
On-site
We're seeking someone who brings: Extensive hands-on experiencein End to End programming Astrategic mindsetand the ability to lead complex projects Strong collaboration skills with cross-functional clinical teams A passion for science-driven programming that impacts patient outcomes
Posted 3 weeks ago
4.0 - 8.0 years
15 - 25 Lacs
hyderabad
Remote
Essential Function The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical Programming Coordinator role on projects, and liaise with sponsors, Data Operations Leads, and other functional areas as required. General areas of responsibility also include import/export programming specification development, test data creation and test data entry, i...
Posted 4 weeks ago
5.0 - 7.0 years
0 Lacs
bengaluru, karnataka, india
Remote
Job Title: Senior Biostatistician Location: Bangalore/Remote Job Type: Full Time Job Summary: As a Senior Biostatistician, you will lead the statistical design, analysis, and reporting of clinical trials and Real World Data (RWD) studies. You will collaborate cross-functionally with clinical, regulatory, data management, and programming teams, serving as a strategic partner throughout the study lifecycle Key Responsibilities: Oversight and co-ordination of statistical activities in clinical studies and regulatory submissions. Provide statistical expertise in the design, planning, evaluation and documentation of clinical trials and RWD studies. Tasks include but are not limited to: Clinical a...
Posted 4 weeks ago
8.0 - 12.0 years
20 - 35 Lacs
hyderabad
Remote
Minimum experience: 10 years. We're seeking someone who brings: Extensive hands-on experience in End to End programming A strategic mindset and the ability to lead complex projects Strong collaboration skills with cross-functional clinical teams A passion for science-driven programming that impacts patient outcomes If you're ready to take on a high-impact role with a global sponsor wed love to connect!
Posted 4 weeks ago
3.0 - 6.0 years
3 - 6 Lacs
aurangabad, west bengal, india
On-site
We are seeking a Sr Statistical Programmer SDTM, ADAM & TLFs to join a leading biopharmaceutical solutions organization. This role is for a skilled professional who can use SAS and other software to develop custom programming code, ensure quality outputs, and act as a lead programmer for multiple projects, driving success by delivering therapies to patients faster. Roles and Responsibilities Use SAS or other software to develop custom programming code for summary tables, data listings, graphs, and derived datasets ( TLFs ). Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with other programmers and biostatisticians to resolve disc...
Posted 4 weeks ago
3.0 - 6.0 years
3 - 6 Lacs
thane, maharashtra, india
On-site
We are seeking a Sr Statistical Programmer SDTM, ADAM & TLFs to join a leading biopharmaceutical solutions organization. This role is for a skilled professional who can use SAS and other software to develop custom programming code, ensure quality outputs, and act as a lead programmer for multiple projects, driving success by delivering therapies to patients faster. Roles and Responsibilities Use SAS or other software to develop custom programming code for summary tables, data listings, graphs, and derived datasets ( TLFs ). Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with other programmers and biostatisticians to resolve disc...
Posted 4 weeks ago
8.0 - 12.0 years
9 - 15 Lacs
remote, india
On-site
We are seeking a Principal Biostatistician with a strong background in efficacy analysis to join our team. The ideal candidate will have extensive experience in creating and validating CDISC-compliant datasets , developing statistical analysis plans, and producing high-quality mock tables, listings, and figures. This role requires a detail-oriented professional with excellent communication skills who can manage multiple projects and collaborate effectively with cross-functional teams. Must-Have Skills Hands-on experience with efficacy analysis. Ability to manage multiple projects and meet tight deadlines. Excellent communication and collaboration skills. Good to Have Skills Proficiency in CD...
Posted 4 weeks ago
5.0 - 10.0 years
15 - 25 Lacs
bengaluru
Remote
Job Title: Senior Biostatistician Location: Bangalore/Remote Job Type: Full Time Job Summary: As a Senior Biostatistician, you will lead the statistical design, analysis, and reporting of clinical trials and Real World Data (RWD) studies. You will collaborate cross-functionally with clinical, regulatory, data management, and programming teams, serving as a strategic partner throughout the study lifecycle Key Responsibilities: Oversight and co-ordination of statistical activities in clinical studies and regulatory submissions. Provide statistical expertise in the design, planning, evaluation and documentation of clinical trials and RWD studies. Tasks include but are not limited to: Clinical a...
Posted 4 weeks ago
5.0 - 9.0 years
0 Lacs
pune, maharashtra
On-site
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 i...
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
pune, maharashtra
On-site
As a Statistical Programmer L2 at our company, you will be reporting to the Principal Statistical Programmer 3/ Lead, Statistical Programming (L4 (3) or M1). Your primary responsibility will be to work independently on the majority of Mapping activities, including SDTM/Client specific mappings of simple and medium complexity for the assigned client within the specified environment for the standard domains. It is essential for you to have a solid understanding of the clinical domain, mapping logic, and data issues. Additionally, learning the product/system/mechanism used for SDTM mapping is a crucial part of your role. Your role will require you to have the following Knowledge, Skills & Abili...
Posted 1 month ago
6.0 - 10.0 years
0 Lacs
hyderabad, telangana
On-site
You are a highly skilled Senior SAS Programmer sought to support statistical programming activities for clinical trials. Your responsibilities include end-to-end SAS programming for analysis and reporting, ensuring regulatory compliance, data standards, and high-quality deliverables. Your expertise in efficacy analysis, SDTM and ADaM generation, and TLF programming is crucial for this role. You will manipulate, analyze, and report clinical trial data using SAS, generating and validating SDTM and ADaM datasets in adherence to CDISC standards. Additionally, you will create and validate Tables, Listings, and Figures (TLFs) for study reports and regulatory submissions. Your role involves develop...
Posted 1 month ago
5.0 - 9.0 years
7 - 11 Lacs
Bengaluru
Work from Office
Job Title: Principal Programmer Statistical Programming Introduction To Role Are you ready to take on a pivotal role in statistical programmingAs a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications Your expertise will drive the creation of Tables, Listings, and Figures for efficacy data analysis, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements You'll lead programming efforts, represent Clinical and Statistical Programming in meetings, and mentor fellow programmers This is your chance to integrate statistical concepts with SAS Programmi...
Posted 1 month ago
0.0 - 3.0 years
0 - 0 Lacs
chennai, tamil nadu
On-site
The role in this Pharmaceutical & Life Sciences full-time job based in Chennai, Tamil Nadu, requires you to oversee the collection, validation, and processing of clinical trial data. You will be responsible for developing and implementing data management procedures for clinical trials, supporting the review of medical coding, and ensuring compliance with applicable regulations, protocols, and standard operating procedures in India. Your role will involve maintaining the highest data quality standards throughout the data lifecycle, from data collection to database lock. It is essential to stay updated on industry best practices, technological advancements, and regulatory requirements related ...
Posted 1 month ago
6.0 - 10.0 years
0 Lacs
karnataka
On-site
We are seeking a skilled Statistical Programmer with a strong background in R Programming to become a valuable addition to our expanding team. This remote position is ideal for individuals who are enthusiastic about clinical data analysis and programming, particularly those with a deep understanding of CDISC standards. As a Statistical Programmer, your main responsibilities will include developing, validating, and managing SDTM, ADaM datasets, and TLFs in compliance with CDISC guidelines. You will be conducting efficacy analyses using R programming, working autonomously on studies, and providing support for clinical trial submissions. Collaboration with various teams in an FSP environment wi...
Posted 1 month ago
6.0 - 11.0 years
9 - 19 Lacs
Hyderabad
Hybrid
1. Advanced skills in statistical and biostatistical analysis 2. Ability to communicate effectively in the English language in person, by phone and in writing 3. Designs, plans, and execute biostatistical components of clinical studies. 4. Uses statistical methodology to conduct studies and prepares statistical components of protocols. 5. Responsible for the statistical components of reports. 6. Develops statistical analysis plans and reporting specifications for clinical studies. 7. Reviews reports and underpins the results with statistical expertise. 8. Prepares and annotates shell data displays 9. Analyzes and interprets results from clinical studies using sound statistical methodology. 1...
Posted 1 month ago
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