Talent.com
This job offer is not available in your country.
Senior Clinical Statistical Programmer (SDTM)

Senior Clinical Statistical Programmer (SDTM)

Tigermed India (Tigermed Clinical Research India Pvt Ltd)kollam, kerala, in
8 hours ago
Job description

Location : Bangalore / Mumbai / Remote (WFH)

Experience : 6.5+ years

Job Responsibilities :

  • Strong oral and written communication skills
  • Develop, map, and validate SDTM datasets (Study Data Tabulation Model) as per CDISC standards and regulatory requirements.
  • Perform Pinnacle 21 (P21) validation and resolve compliance issues for FDA / PMDA submissions.
  • Work with Real-World Data (RWD) to standardize and transform data into CDISC-compliant formats.
  • Worked with biomarker data, ensuring alignment with clinical datasets to support integrated analysis and interpretation.
  • Experienced in developing CDISC submission packages, including Define.xml, cSDRG, and ADRG documentation, ensuring compliance with regulatory standards.
  • Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Analysis Plans, SDTM / ADAM specifications, datasets, and TLFs.
  • Ensures excellence and high quality in the programming of analysis-ready datasets, tables, listings, and figures for which they are responsible.
  • Provide support to mentor and train junior team members.
  • Ensure all statistical activities are in accordance with internal and external quality standards, SOPs / WPDs, ICH-GCP, and / or other international / local regulatory requirements.
  • Proficiency in SAS and CDISC for programming, as well as programming management skills for the project leader role.

Core Strength :

  • The candidate should be technically sound and have hands-on experience in Statistical Programming.
  • Responsible for appropriate code reviews and ensuring quality checks are performed on deliverables.
  • Issues would be raised about timelines, deliverables, and quality directly, and he / she would be the key communicator in resolving problems at a team level.
  • Providing support for onboarding additional programmers and mentoring them.
  • Relevant industry experience is mandatory. Freshers may kindly refrain from applying.
  • Create a job alert for this search

    Senior Statistical Programmer • kollam, kerala, in

    Related jobs
    • Promoted
    Senior Statistical Programmer – Clinical Trials

    Senior Statistical Programmer – Clinical Trials

    beBeeDataAnalystAlappuzha, Kerala, India
    We are seeking a highly skilled lead statistical programmer with expertise in SAS and R programming to support clinical trial data analysis and regulatory submissions. Author, validate, and document...Show moreLast updated: 4 days ago
    • Promoted
    Statistical Programmer (data standards)

    Statistical Programmer (data standards)

    IQVIAKollam, IN
    Senior Clinical data standards specialist.Statistical programming domain especially clinical operations (In the area of Data management, Database programming, Data Standards, Statistical programmin...Show moreLast updated: 1 day ago
    • Promoted
    Senior / Principal Statistical Programmer

    Senior / Principal Statistical Programmer

    VeramedKollam, IN
    Key Responsibilities The job tasks listed below outline the scope of the position.The application of these tasks may vary, based on current business needs. Technical : • Perform consistency review of...Show moreLast updated: 1 day ago
    • Promoted
    Fusion HCM Sr. Technical Consultant

    Fusion HCM Sr. Technical Consultant

    Best Infosystems Ltd.Thiruvananthapuram, IN
    Technical Consultant_Full-Time_Remote.Oracle HCM Cloud Senior Technical Developer with minimum experience of 8 years in technical development. Candidate must have technical experience for US and Can...Show moreLast updated: 30+ days ago
    • Promoted
    Transforming Healthcare through Data Insight

    Transforming Healthcare through Data Insight

    beBeeDataScientistAlappuzha, Kerala, India
    PulsePoint seeks a seasoned Senior Data Scientist to spearhead the development of data-driven solutions.The successful candidate will drive innovation and collaboration across internal teams, empow...Show moreLast updated: 2 days ago
    • Promoted
    Healthcare Research Analyst - 45737

    Healthcare Research Analyst - 45737

    TuringKollam, IN
    Based in San Francisco, California, Turing is the world’s leading.AI labs and a trusted partner for global enterprises deploying advanced AI systems. Turing supports customers in two ways : first, by...Show moreLast updated: 11 days ago
    • Promoted
    LLM Data Scientist

    LLM Data Scientist

    Insight GlobalThiruvananthapuram, IN
    Experience building out LLM platforms (must have platform level integration experience).Advanced proficiency in Python, especially with data science and machine learning libraries.Experience in dev...Show moreLast updated: 1 day ago
    • Promoted
    Lead Statistician - Clinical Trials

    Lead Statistician - Clinical Trials

    beBeeBiostatisticianAlappuzha, Kerala, India
    The Senior Biostatistician leads statistical strategies and deliverables in support of clinical trials under the guidance of Head of Biostatistics, ensuring high-quality timely deliverables that me...Show moreLast updated: 2 days ago
    • Promoted
    Clinical DataProgrammer

    Clinical DataProgrammer

    SIROKollam, Kerala, India
    Hands on exposure in reviewing Clinical Data in JReview.Configure data extraction and transformations in an individual contributor role across multiple data sources at the study level as defined by...Show moreLast updated: 2 days ago
    • Promoted
    Kinaxis Maestro Solutions Consultant

    Kinaxis Maestro Solutions Consultant

    Scott Sheldon India Pvt. Ltd.Kollam, IN
    Scott Sheldon, LLC is a supply chain consulting firm focused on implementing world-class technologies within our customers’ supply chain operations. For over twenty years, we have built an impeccabl...Show moreLast updated: 30+ days ago
    • Promoted
    Bioinformatics Engineer

    Bioinformatics Engineer

    TechNET IT Recruitment LtdAlappuzha, IN
    Bioinformatics Engineer (Nextflow).TechNET IT has partnered with a global biopharmaceutical leader at the forefront of data-driven drug discovery and healthcare innovation.This is a chance to join ...Show moreLast updated: 1 day ago
    • Promoted
    Senior Biostatistician

    Senior Biostatistician

    Advanced ClinicalAlappuzha, IN
    The Senior Biostatistician is responsible for leading, developing, implementing, and overseeing statistical strategies and deliverables in support of the Client’s R&D sponsored clinical trials.Unde...Show moreLast updated: 30+ days ago
    • Promoted
    HCM Technical Expert

    HCM Technical Expert

    beBeeCompensationAlappuzha, Kerala, India
    We are seeking an expert in compensation and equity for Oracle HCM tools such as OTBI, BI Publisher, and HDL / SDL.The successful candidate will possess strong problem-solving skills, the ability to ...Show moreLast updated: 2 days ago
    • Promoted
    Senior Statistical Programmer FSP.

    Senior Statistical Programmer FSP.

    CytelThiruvananthapuram, IN
    Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you...Show moreLast updated: 21 days ago
    • Promoted
    Senior Biostatistician

    Senior Biostatistician

    Unicon Pharma IncThiruvananthapuram, IN
    Location : Remote / Bangalore, India.Leads collaborations with clinical investigators to determine study design, contributes to protocol development, authors statistical analysis plans, performs stat...Show moreLast updated: 30+ days ago
    • Promoted
    Product Manager (AI for Clinical Research)

    Product Manager (AI for Clinical Research)

    Tilda ResearchKollam, IN
    Product Manager (AI for Clinical Research).We're looking for a Product Manager who combines.You'll work directly with the founders to shape our product strategy, prioritize features that deliver im...Show moreLast updated: 16 days ago
    • Promoted
    Senior Data Scientist (AI & Data)

    Senior Data Scientist (AI & Data)

    RecroAlappuzha, IN
    Role : Senior Data Scientist (AI & Data).Location : Remote (Work from Home).We’re hiring a Senior Data Scientist to build the next generation of intelligent. This is a high-impact role at the interse...Show moreLast updated: 1 day ago
    • Promoted
    EDI Sterling Consultant

    EDI Sterling Consultant

    BayOne SolutionsThiruvananthapuram, IN
    Configure, maintain, and troubleshoot EDI solutions using IBM Sterling to support seamless electronic data interchange with business partners. Collaborate with cross-functional teams to integrate ED...Show moreLast updated: 30+ days ago