69 Tlf Jobs - Page 2

ROLES and RESPONSIBILITIES: Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency Support the development and implementation of a programming ecosystem to enable successful project deliverables Review statistical analysis plans, mock-shells, database set-up specifications Validate or Review the Programming packages (includes the aCRFs, specifications and datasets, Define.XML and Reviewers Guides (for both SDTM and ADaM) Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables Develop innovative solutions...

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...

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...

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...

. 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...

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.

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...

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!

The ideal candidate for the Senior Statistical Programming position should have a minimum of 3-8 years of experience. You should possess a strong understanding of SAS Base/Macros/GTL and have hands-on experience in SDTM/ADAM/TLFs creation following CDISC standards. Your expertise should lie in both Base and Advance SAS programming. You will be responsible for developing complex SAS macros that can be applied across Therapeutic Areas in various studies. Additionally, your role will involve reviewing the SAS programs that have been developed. Proficiency in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components is crucial for this position. As a Senior Statistical Programm...

3- 8 years of experience for Sr Statistical programming position, having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Expertise in Base and Advance SAS programming. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Location : - Bengaluru,Mumbai,Pune,Hyderabad Contact Person : - Sangeetha Tamil

Role & 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 pr...

Role & responsibilities: 5-8 years of experience in SDTM / ADaM / TFls. Develop and validate SDTM/ ADaM data sets, TDLs. Support Safety & efficacy Analyses Contribute to E-submission generating define.XML and ADRG / SDRG and leading clinical study Trails 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....

Good to Have Skills Proficiency in CDISC standards, particularly ADaM (Analysis Data Model) and SDTM (Study Data Tabulation Model). Experience in creating and validating ADaM datasets, ensuring they are analysis-ready and compliant with regulatory requirements. Hands-on experience with efficacy analysis, including the creation of statistical analysis plans (SAPs) and mock TLFs (Tables, Listings, Figures). Soft Skills Excellent communication skills for collaborating with cross-functional teams and presenting findings. Attention to detail and strong problem-solving abilities. Ability to manage multiple projects and meet deadlines. Must Have Skills - Hands-on experience with efficacy analysis.

Minimum experience: 8 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 we’d love to connect!

- Experience Required: 5+ years into clinical SAS Programming Requirements: - Strong experience in Base SAS, Advance SAS, SDTM dataset & specification generation. - Must have good experience in ADaMs, table, listing and figure creation. - Good to have study lead exposure.

Role & responsibilities JOB DESCRIPTION The Statistical Programmer I (SP I) or Statistical Programmer II (SP II) Programs all tables, listings and graphs necessary for an assigned clinical study report (CSR); Programs customized data displays, (including data listings, summary tables and routine graphics) in accordance with the approved statistical analysis plan (SAP) and shell displays for clinical research studies; Writes code using Base SAS programs, SAS procedures, or standardized macros; Analyzes protocol, SAP, existing shells/templates as needed to understand structure and content of data; Performs data checks as needed, to ensure integrity and correctness of data displays; Prepares do...

#hiring . Know anyone who might be interested? "Remote Opportunity" Veeda Lifesciences is seeking a passionate "Biostatistician II". Interested candidates can share an updated CV to mahendra.t3705@veedalifesciences.com Position Summary The Biostatistician II is responsible for collaborating with multiple Sponsors across several therapeutic areas in all phases of clinical trials and combining statistical expertise, technical knowledge on data processing and the ability to handle complex scientific/medical aspects of the study to efficiently support the Companys global clinical program. Role & responsibilities Acts under the supervision of more experienced biostatisticians of the Department, t...

Clinical SAS programming Location: Remote Immediate/15 D notice Experience: 10+ years Looking for a candidate who is into Clinical programming and report generation (excluding ADaM, SDTM, and TLF) who will be supporting data management team. (Candidates)clinical programmers play a crucial role in creating accurate reports. However, a significant challenge is that 1 in 3 candidates may be fake. Experience of Creating missing pages, patient profile reports, reconciliation reports Programming: BASE SAS, macros, SQL. Regulatory Knowledge: FDA, EMA, ICH guidelines. Soft Skills: Attention to detail, communication, problem-solving. BASE SAS Certified is Plus candidates should have created SAS repor...

Master s degree, equivalent, or higher in Biostatistics, mathematics, computing, or related field Minimum 8 + years of experience, or an equivalent combination of education or experience to successfully perform the key responsibilities of the job Experience with SAS statistical software Must have experience inSDTM and ADAM and TLF Experience leading statistical programming activities in clinical research PreviousOncology experience(safety and efficacy) in pharmaceutical research or CRO setting preferred Knowledge of one or more statistical software packages (SAS preferred + R) used to conduct statistical analyses Experience withCDISC standardsand other industry guidance/dictionaries like REC...

Develop, validate, and maintain SDTM, ADaM datasets, and TLFs as per CDISC guidelines Perform efficacy analyses using R programming Work independently on studies and support clinical trial submissions Collaborate with cross-functional teams in FSP.

Job Overview Provide advanced technical expertise to develop and maintain programs to meet internal and external clients needs. Plan and lead the development of project-related solutions to the full scope of statistical programming tasks. Provide technical expertise to the Statistical Programming department. Essential Functions • Perform and plan: (i) the programming, testing, and documentation of programs for use in creating statistical tables, figures and listing summaries, (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 the integration o...

- UG/PG in Statistics, Mathematics, Life sciences, Engineering or Computer related subjects - Min. 6 yrs Exp in Statistical Programming-TLF,ADAM,SDTM,SAS Macros Developement CALL@WHATSAPP- RUKHSAR-9899875055 SHRUTI- 9911988551 SUHANI-9911988552

Role & responsibilities 1) Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials 2) Experience creating and working with Utility Macros 3) Experience creating specification 4) Experience with CDSIC standards including CDASH or SDTM/ADaM 5) Ability to work independently and as part of a team 6) Being open to new learnings and sharing with team members 7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 8) Proficient in using SAS EG/Studio for programming 9) Familiar with Unix environment and programming 10) Prior working experience in Vaccines or Oncology is an added advantage 11) Familiarity with m...

Greetings from You & I Consulting! We've proudly helped candidates build careers at 64+ top MNCs across India, and were excited to bring you a new opportunity with a leading global company. If you have experience in Statistical Programming , this role is your next step forward! To Apply: Send your CV via WhatsApp or Call : Puja- (8250242229) or email your resume at :- puja@careersuni.com Shift - General Shift Open Locations :- Mumbai Pune Bangalore Hyderabad Indore Ahmedabad Key Responsibilities: Lead and oversee statistical programming activities for clinical trials at compound/indication/TA level Design and develop SDTM and ADaM datasets as per CDISC standards Generate Tables, Listings, an...

Roles And Responsibilities: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safety and efficacy Develop and/or validate Tables, Listings, and Figures using SAP and mock shells Create or review P21 reports, define packages [Define.xml] and Reviewers guide [RGs] for CDISC Data Standards Ability to work independently and as part of a team environment Provide the status of assigned tasks to the Study Lead Programmer Actively participating in the study meetings and support as backup lead Identify, communicate, and manage study-based risks ...