Clinical Data Lead

1 week ago

bharatpur, India beBeeProgramming Full time

Job DescriptionWe are seeking a skilled professional to lead statistical programming activities for clinical studies and projects. As a Global Lead Statistical Programmer, you will be responsible for overseeing the programming and project standards to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis.Lead one or more Phase I-IV studies programming activities as per the project strategies.Work independently implementing and executing the programming and project standards to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis.Work closely with internal partnering functions, stakeholders, and external functional service providers to ensure all the programming deliverables are delivered in a timely manner with high quality.Participate in and contribute to development of standard macros, libraries, processes and act as a team player on the various programming tasks.Key Roles and ResponsibilitiesThe successful candidate will have the following responsibilities:Develop and maintain programming documentations following programming standards and processes. Create CDISC standard SDTM mapping specifications and ADaM specifications.Develop and oversee the development of SAS programs for the creation of SDTM and ADaM datasets following CDISC standards and reports (Tables, Listings and Figures).Contribute to the development of standard and utility macros, participate in establishing and maintaining statistical programming standards.Participate in the CRF annotation, review of SAP, TLFs specifications development and TLFs review.Required Skills and QualificationsTo be successful in this role, you will need to possess the following skills and qualifications:Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 7-8+ years of programming experience in processing clinical trial data in the biotechnology, pharmaceutical, CRO or health care related industry.Oncology Therapeutic area preferred.Strong SAS programming skills in a clinical data environment with excellent analytical skills. Working knowledge of other programming languages such as R, Python etc. is a plus.Great knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles) and regulatory submissions (NDA, ANDA etc.).Extensive working knowledge of using and implementing CDISC standards, Regulatory guidance and TAUG. Prior PTL experience, attention to detail and able to adapt to a fast-paced environment.BenefitsWe offer a dynamic and supportive work environment that encourages growth and development. The successful candidate will receive:A competitive salary package.Opportunities for career advancement and professional development.A collaborative and inclusive team culture.Flexible work arrangements to support work-life balance.

  • Lead Clinical Reviewer

    7 days ago

    bharatpur, India beBeeMedical Full time

    Medical OfficerThe Medical Officer will review and verify large volumes of patient medical records with precision, perform clinical reviews, and prepare detailed reports including chronologies and timelines, summaries, mass tort matrix and medical opinions on case validity and valuation.Summarize and analyze medical records for pre and post settlement...

  • Lead Clinical Neurologist

    2 weeks ago

    bharatpur, India beBeeneurologist Full time

    Job TitleWe are seeking an accomplished Neurologist to lead our clinical team in providing comprehensive neurological care to adult patients with a wide range of neurological conditions.About the RoleDiagnose and manage neurological conditions, including stroke, epilepsy, Parkinson's disease, multiple sclerosis, neuropathies, and headache disorders.Oversee...

  • Lead Data Analyst

    2 weeks ago

    bharatpur, India beBeeStatistical Full time

    Senior Statistical ProgrammerWe are seeking a highly experienced Senior Statistical Programmer to work on clinical development programs in various therapeutic areas.Develop SDTM, ADaM specifications, datasets, reviewer's guides and define.xml files for multiple studiesCreate SAS programs generating datasets, complex listings, tables and graphsDeliver...

  • Clinical Data Management Expert

    5 days ago

    bharatpur, India beBeeClinical Full time

    Job Title: Clinical EDC SpecialistThis role involves creating and validating clinical trial setup processes, including eCRF specifications and edit checks. The ideal candidate will have expertise in UAT scripts and be able to troubleshoot database setup.Key Responsibilities:Create eCRF specifications, design, develop and validate clinical trial setup...

  • Lead Data Developer

    2 weeks ago

    bharatpur, India beBeeClinical Full time

    Job Summary:This position involves developing, validating, and maintaining datasets for clinical trials. The role requires ensuring accuracy, consistency, and regulatory compliance in programming deliverables.Develop ADaM datasets, TLFs, and analytical outputs for clinical trials.Support Oncology studies by delivering accurate, consistent, and compliant...

  • Technical Director of Clinical Trials

    3 days ago

    bharatpur, India beBeeStatistical Full time

    Job RoleWe are seeking a skilled professional to lead our statistical programming efforts. As Senior Technical Lead, you will oversee the development and maintenance of datasets, reports, and outputs for clinical trials.Develop, validate, and maintain SDTM/ADaM datasets, TLFs (Tables, Listings & Figures) and submission-ready outputs.Perform end-to-end...

  • Clinical Operations Expert

    5 days ago

    bharatpur, India beBeeDoctor Full time

    Leader in Clinical ExcellenceWe are seeking a visionary Medical Doctor to lead our clinical operations, overseeing diagnostics interpretation, treatment protocols, and multidisciplinary team collaboration for effective health optimization strategies.Conduct in-person and virtual patient consultations.Design personalized wellness and IV therapy...

  • Data Platform Strategist

    2 weeks ago

    bharatpur, India beBeeSolution Full time

    Job Overview:We are seeking a visionary Senior Solutions Architect to lead the design and delivery of data-driven solutions across Clinical, Commercial, and Medical Affairs domains.Develop end-to-end data platform architectures that meet pharma clients' needs for high-quality and compliant delivery.Key Responsibilities:Create scalable solutions on leading...

  • Clinical Site Quality Assurance Specialist

    2 weeks ago

    bharatpur, India beBeeQuality Full time

    Clinical Site Quality Assurance SpecialistClinical site quality assurance specialists play a crucial role in ensuring compliance and quality at clinical trial sites. Their primary responsibility is to conduct site audits, review documentation, and verify adherence to protocols, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and regulatory...

  • Data-Driven Solutions Specialist

    4 days ago

    bharatpur, India beBeeArtificialintelligence Full time

    AI Researcher in Pharma Data ScienceWe are seeking an expert AI researcher to lead the development of data-driven solutions in pharma domain.Leverage foundation models for healthcare and pharma-specific datasets.Collaborate with computational biologists and data scientists to enhance research outcomes.Package AI-driven solutions for integration into clinical...