Senior Lead Clinical Data Manager

4 days ago

rajahmundry, India beBeeStatisticalProgrammer Full time

Lead Statistical ProgrammerProvide strategic leadership for one or more Phase I-IV studies programming activities to ensure project strategies are implemented effectively.Implement and execute high-quality programming and project standards to support ongoing clinical studies, requests for study reports, regulatory submissions, and ad hoc/post hoc analysis.Collaborate closely with internal and external stakeholders to ensure timely delivery of programming deliverables with high quality.Contribute to the development of standard macros, libraries, processes, and participate as a team player in various programming tasks.Key Responsibilities:Lead statistical programming activities for a therapeutic area or compound/indication within multiple studies/projects to ensure timely and high-quality programming deliverables in assigned projects and areas.Develop and maintain comprehensive 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 creating 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 CRF annotation, review of SAP, TLFs specifications development, and TLFs review.Handle all P21 related items and eCRT package including aCRF, define.XML, cSDRG, ADRG, and ARM for regulatory submissions to FDA/EMA/PMDA or other agencies.Support global regulatory authority submissions following guidelines (sdTCG, DSC, eCTD) and work closely with partnering functions to address health authority requests.Demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect, ownership, teamwork, and accountability.Understand scope of work, plan, and complete deliveries and timelines with the study team, programming lead, and management.Perform end-to-end programming activities, act as a team player, and SME.Focus on timelines and quality ensuring that programming deliverables meet regulatory submission requirements.Ensure all work is completed adhering to internal SOPs where applicable.Mentor and coach new hires and junior programmers. Require good collaborative skills.Qualifications and Skills: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 biotechnology, pharmaceutical, CRO, or healthcare-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).Extensive working knowledge of using and implementing CDISC standards, Regulatory guidance, and TAUG. Prior PTL experience, attention to detail, and ability to adapt to fast-paced environment.Ability to work independently and on global interdisciplinary teams. Good organizational, interpersonal, and communication skills. Positive attitude, team player, and growth mindset.Problem-solving and innovative skills that demonstrate initiative and motivation.Demonstrated and applied SAS programming skills. SAS certificates a plus.

  • Oncology Clinical Trials Specialist

    1 week ago

    rajahmundry, India beBeeTechnicalLead Full time

    About the RoleThe Senior Technical Lead will be responsible for creating, validating, and maintaining SDTM/ADaM datasets, TLFs, and submission-ready outputs. They will conduct end-to-end statistical programming activities across all phases of Oncology clinical trials and support integrated analysis activities for ISS and/or ISE as part of regulatory...

  • Senior Data Scientist

    1 week ago

    rajahmundry, India beBeeClinical Full time

    Job TitleWe are seeking an accomplished Clinical Programming Lead to support end-to-end clinical programming activities across multiple studies.The role demands a high level of technical expertise, autonomy, and the ability to collaborate effectively within cross-functional and global teams.Key responsibilities include:Programming, validation, and...

  • Nurse/Clinic Coordinator

    4 weeks ago

    Rajahmundry, India Dr Preethi's Ethicure Full time

    Company Description We suggest you enter details here. Role Description This is a full-time on-site role for a Nurse/Clinic Coordinator at our facility in Kochi. The Nurse/Clinic Coordinator will be responsible for coordinating clinical operations, providing quality patient care, managing patient flow, and ensuring the seamless day-to-day running of the...

  • Data Architect Jobs

    7 days ago

    rajahmundry, India beBeeDataEngineering Full time

    Senior Data Architect - Data EngineeringWe are seeking a highly skilled Senior Data Architect to lead our data engineering team in designing and delivering cutting-edge data platforms for the pharmaceutical industry.About the Role:This is a unique opportunity to leverage your expertise in data architecture, engineering, and delivery to drive business growth...

  • Senior Biostatistics Specialist

    1 week ago

    rajahmundry, India beBeeBiostatistics Full time

    Senior Biostatistics SpecialistJob Overview:As a seasoned biostatistician, you will play a pivotal role in driving the success of our pharmaceutical clients by delivering high-quality statistical programming services.Design and implement efficient data management systems to support clinical trials, ensuring seamless data analysis and reporting.Collaborate...

  • Senior Data Analyst

    1 week ago

    rajahmundry, India beBeeDataAnalysis Full time

    Statistical Analyst RoleSeeking a skilled statistical analyst to drive data-driven decision making.Key ResponsibilitiesAnalyze complex data sets using SAS and R programming languagesDevelop and maintain efficient statistical models for clinical trialsCollaborate with cross-functional teams to identify business opportunitiesStrong understanding of statistical...

  • Lead Data Strategist

    7 days ago

    rajahmundry, India beBeeDataAnalyst Full time

    Job Title: Senior Data AnalystAs a Senior Data Analyst, you will lead data projects that align with strategic goals and drive measurable value. You will leverage expertise in Power BI to design enterprise-grade solutions using complex dashboards, reports, and data models.You will collaborate closely with cross-functional teams to gather requirements, refine...

  • Clinical Research Quality Assurance Specialist

    1 week ago

    rajahmundry, India beBeeQuality Full time

    Job Overview:Clinical Site Auditors are accountable for ensuring compliance and quality at clinical trial sites by conducting site audits, reviewing documentation, and verifying adherence to protocols, GCP, GLP, and regulatory requirements.Conduct comprehensive audits of clinical research sites across all phases.Review case report forms (CRFs), informed...

  • Data Analyst

    1 week ago

    rajahmundry, India beBeeDataAnalyst Full time

    Job OverviewWe are seeking a highly skilled Data Analyst to join our team. As a key member of the data analysis unit, you will be responsible for developing and maintaining ADaM datasets, TLFs, and other analytical outputs for clinical trials.Key Responsibilities:Develop, validate, and maintain ADaM datasets, TLFs, and other analytical outputs for clinical...

  • Senior Data Analyst

    1 week ago

    rajahmundry, India beBeeData Full time

    Statistical Programming Leadership OpportunityWe are seeking an experienced Statistical Programmer to lead our programming activities for Phase I-IV studies.This role involves implementing and executing programming standards to support ongoing clinical studies, regulatory submissions, and ad hoc/post hoc analysis.You will work closely with internal...