K3-Innovations, Inc. | LEAD STATISTICAL PROGRAMMER | india

2 weeks ago


Delhi, India K3-Innovations, Inc. Full time
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/ADaM/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 (eCTD).Provides primary programming and QC support for any internally produced outputs.Reviews and approves SAS programming instructions and CDISC/ADaM specifications.Performs statistical analysis and simulations using SAS to support clinical trial design and data interpretation.Reviews and provides input on eCRF 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 8 years of relevant experience in the pharmaceutical/biotechnology industryExperience 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/sNDA submissions is required.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 ADaM data set structures and requirementsProficiency 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 skillsAbility to work well in a team environment as a contributor.Open, engaging, and transparent work styleAbility to competently manage multiple competing priorities, switching priorities quickly as needs change. Must be comfortable working in a very fast-paced environment



  • Delhi, India K3-Innovations, Inc. Full time

    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...


  • delhi, India K3-Innovations, Inc. Full time

    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...


  • delhi, India K3-Innovations, Inc. Full time

    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...


  • Delhi, Delhi, India K3-Innovations, Inc. Full time

    About K3-InnovationsK3-Innovations, Inc. is a leading technology company revolutionizing data workflows in the biopharma industry. We are seeking an experienced Senior Backend Engineer to join our team and contribute to building a cutting-edge database-driven SaaS platform.Job SummaryWe are looking for a highly skilled Backend Engineer with expertise in...


  • Delhi, India K3-Innovations, Inc. Full time

    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...


  • Delhi, Delhi, India K3-Innovations, Inc. Full time

    Job DescriptionWe are seeking a highly skilled Senior Backend Developer to join our team at K3-Innovations, Inc. and contribute to the development of our cutting-edge biopharma data platform.


  • Delhi, India K3-Innovations, Inc. Full time

    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...


  • Delhi, India IQVIA India Full time

    Job Title : Senior Statistical Programmer Experience : 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...


  • Delhi, India IQVIA India Full time

    Job 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...


  • delhi, India IQVIA India Full time

    Job 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...


  • Delhi, India IQVIA Full time

    Role: Senior Statistical Programmer Skill: Efficacy ADaM and TFL ADTTE – PFS, OS, DOR, BOR, ORR),TA : OncologyMode: HybridExperience: 6- 10 yearsJob Location: PAN IndiaJob OverviewAs a Senior Statistical Programmer, you will provide programming expertise to develop and maintain programs to meet internal and external clients’ needs. Provide and assist...


  • delhi, India IQVIA India Full time

    Job 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...


  • Delhi, India Trigent Software Inc Full time

    Job Title: Statistical ProgrammerEmployment Type: Full timeLocation: Bengaluru, IndiaNote: (5-6 Months Remote then Onsite)Responsibilities:• Develop and maintain programs using R to generate Tables, Listings, and Figures (TLFs) as part of clinical trial reporting.• Implement CDISC standards (SDTM, ADaM) for clinical data submission and reporting.•...


  • Delhi, Delhi, India ACL Digital Full time

    At ACL Digital, we are seeking a skilled Statistical Programmer Leader to join our team. This role offers a competitive salary of $120,000 - $150,000 per annum, depending on experience.The successful candidate will be responsible for leading the development and validation of Statistical Analysis Plans, SDTM domains, ADaM datasets, Tables, Listings, and...


  • Delhi, India Trigent Software - Professional Services Full time

    We 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+ years- Pinackel 21: 4+ years- R...


  • Delhi, India IQVIA Full time

    Role: Senior Statistical Programmer Skill: SDTM/ADAM/TLFMode: Hybrid/RemoteExperience: 5- 10 yearsJob Location: PAN 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...


  • Delhi, Delhi, India Parexel Full time

    Job Profile Summary The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with mínimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of...


  • Delhi, India IQVIA India Full time

    Job 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...


  • Delhi, India Premier Research Full time

    What you'll be doing:- Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells- Performs quality control (source code review, double-programming and log review) of SAS programs- Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications- Prepares specifications for CDISC...


  • Delhi, India Veramed Full time

    As 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...