Senior Bio Statistician-R programming:-ADaM,ANOVA, ANCOVA

10 hours ago

Chennai, Tamil Nadu, India Cortex Consultants Full time ₹ 1,20,000 - ₹ 6,00,000 per year
Overview The Senior Biostatistician plays a pivotal role in the research and development of clinical projects by applying statistical methods and providing insights through data analysis. This position requires expertise in R programming and a deep understanding of statistical techniques such as Analysis of Variance (ANOVA) and Analysis of Covariance (ANCOVA). The Senior Biostatistician will not only collaborate with various teams to ensure compliance with regulatory standards but also contribute to the development of statistical analysis plans and the interpretation of results. Given the importance of accurate statistical evaluations in clinical trials, this role is critical to the decision-making processes that impact patient outcomes and the overall success of pharmaceutical developments. You will lead projects and mentor junior biostatisticians, making your contribution vital to enhancing the organization's capabilities and ensuring the integrity of research findings. Key Responsibilities
  • Develop and implement statistical analysis plans for clinical studies.
  • Perform statistical analyses using R, focusing on ADaM, ANOVA, and ANCOVA methodologies.
  • Collaborate with clinical research teams to define analysis objectives and timelines.
  • Create and validate datasets to ensure accuracy and compliance with regulatory standards.
  • Generate and interpret statistical results to contribute to clinical study reports.
  • Work closely with data managers to design data collection tools and processes.
  • Conduct exploratory data analyses and prepare visualizations to communicate findings effectively.
  • Participate in protocol development and provide statistical input on study design.
  • Mentor and supervise junior statisticians and biostatisticians.
  • Conduct peer reviews of statistical analyses and reports executed by peers.
  • Stay current with biostatistics trends, methodologies, and regulatory guidance.
  • Present statistical findings to stakeholders and at scientific meetings.
  • Assist in regulatory submissions by preparing statistical sections of FDA submissions and other documents.
  • Participate in interdisciplinary project meetings and collaborate with cross-functional teams.
  • Continuously improve statistical practices and methodologies within the team.
Required Qualifications
  • Master's or PhD in Biostatistics, Statistics, or related field.
  • Minimum of 5 years of experience in a biostatistical role within the pharmaceutical or biotechnology industry.
  • Proficiency in R programming for statistical computing and data visualization.
  • Experience with ADaM data standards and regulatory guidelines.
  • Strong knowledge of ANOVA, ANCOVA, and other statistical methodologies.
  • Excellent understanding of clinical trial design and regulatory requirements.
  • Proficiency in other statistical software such as SAS is highly desirable.
  • Exceptional analytical and problem-solving skills.
  • Ability to communicate complex statistical concepts to non-statistical audiences.
  • Experience in leading statistical analyses for multiple clinical projects simultaneously.
  • Strong attention to detail and commitment to data integrity.
  • Demonstrated ability to work collaboratively within a team environment.
  • Experience mentoring or training junior staff members.
  • Published research or contributions to scientific literature is a plus.
  • Excellent organizational and time management skills.
  • Strong interpersonal skills and ability to work in a diverse environment.

  • Credit Risk Modeler

    2 weeks ago

    Chennai, Tamil Nadu, India Ford Motor Company Full time ₹ 1,40,000 - ₹ 28,00,000 per year

    Potential candidates should have knowledge in general math modeling, Machine Learning (ML) and related Operations Research(OR) and simulation techniques. Candidates should have hands-on experience in developing quantitative models. They shouldpossess the ability to translate a business problem into an analytical problem, recommend, implement and validate...

  • Senior SAS Programmer

    4 days ago

    Chennai, Tamil Nadu, India Veristat Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Description:Senior SAS ProgrammerThe Senior SAS programmer leads the programming activities for various purposes including CSRs, DSMBs, interim analyses, manuscripts, etc. Mainly supports statistical programming of statistical analysis plan (SAP)-planned tables, data listings, and graphs for CSRs, as well as integrated summaries of safety and efficacy,...

  • RA Spec III

    2 weeks ago

    Chennai, Tamil Nadu, India Bio-Rad Laboratories, Inc. Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Overview:The Regulatory Affairs Specialist position is responsible for RA/QA and co-ordinate with supply chain team, responsibilities includes but not least; maintaining of documentation, and support import requirements ensuring products released comply with import requirements.Support RA Manager for product registration and regulatory compliance and to...

  • Senior Associate, Senior Statistical Data Scientist

    2 weeks ago

    Chennai, Tamil Nadu, India Pfizer Full time ₹ 8,00,000 - ₹ 16,00,000 per year

    SummaryAn Individual Contributor roleProductive hands on programming, supporting deliverables in the study/project/portfolio/standards team, of medium – high complex statistical programming deliverables to support assets and study teamsPerforms tasks with limited supervision early in role and independently later in role.Is capable of handling...

  • Senior Statistical Data Scientist

    2 days ago

    Chennai, Tamil Nadu, India Pfizer Full time ₹ 1,00,00,000 - ₹ 2,00,00,000 per year

    An Individual Contributor roleProductive hands on programming, supporting deliverables in the study/project/portfolio/standards team, of medium – high complex statistical programming deliverables to support assets and study teamsPerforms tasks with limited supervision early in role and independently later in role.Is capable of handling standards/study...

  • senior Mobile Testing Engineer

    2 weeks ago

    Chennai, Tamil Nadu, India Programming Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Company Description empowers global enterprises to scale in a digital-first world with intelligent next-gen digital solutions. With 22+ years of excellence, 2200+ tech experts, and delivery hubs in the USA, India, Singapore, Mexico, and Ukraine, has successfully executed over 1000 projects across diverse industries. We specialize in AI & Machine Learning,...

  • Engineer- Ergonomic and Digital Pre-Assembly 5(DPA5)

    4 days ago

    Chennai, Tamil Nadu, India Ford Motor Company Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Advanced Feasibility and Planning Program Roles:Perform final assembly Manufacturing feasibility, planning and support program implementation.This role is to work on DPA5 & Ergo Deep dive studies for IMG region programs.Create, modify and update program specific process sheetsDPA5Perform checksRaise part/process issues as identified to programRe-perform...

  • Statistical Data Sciences Lead

    1 week ago

    Chennai, Tamil Nadu, India Pfizer Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    At least 7-8 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.Accountable for multiple projects/ongoing work activities (timelines, work plans, deliverables) of moderate complexity within a Work TeamContributes to upto 70% of their time to programming deliverables assigned within the scope of the function in either SAS, R or...

  • Senior Research Associate- II

    4 days ago

    Chennai, Tamil Nadu, India Kemin Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    OverviewLocation: ChennaiSupport the development of fermentation- based polymers/proteins for KAQ. Be a part of Global R&D team and work on multiple R&D Projects. Contribute to writing research reports and presentations.ResponsibilitiesDesign experiments under guidance to optimize fermentation. Conduct shake flask fermentation experiments in the lab to...

  • Senior Research Associate- II

    2 days ago

    Chennai, Tamil Nadu, India Kemin Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Overview:Location: ChennaiSupport the development of fermentation- based polymers/proteins for KAQ.Be a part of Global R&D team and work on multiple R&D Projects.Contribute to writing research reports and presentations.Responsibilities:Design experiments under guidance to optimize fermentation.Conduct shake flask fermentation experiments in the lab to...