Leading Biostatistics Expert

22 hours ago

Ghaziabad, Uttar Pradesh, India beBeeBiostatistician Full time US$ 1,20,000 - US$ 1,70,000
Senior Biostatistician Role

Job Summary:

The Senior Biostatistician plays a vital role in leading the development and implementation of statistical strategies for clinical trials. This position contributes to planning, executing, and interpreting statistical analyses across development programs.

Key Responsibilities:

  • Lead biostatistics efforts for assigned studies and projects
  • Participate in study design discussions, including protocol development, endpoint definition, and sample size estimation
  • Author and review Statistical Analysis Plans (SAPs), including mock tables, figures, and listings (TFLs)
  • Oversee and ensure execution of statistical analyses per SAP in collaboration with programming and CRO partners
  • Provide statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables
  • Communicate project status to management and escalate issues or risks in a timely manner
  • Provide statistical input and review for clinical study reports, regulatory documents, and publications
  • Perform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards
  • Lead or support regulatory interactions on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations
  • Deliver statistical presentations to internal and external stakeholders, or regulatory authorities as needed
  • Contribute to the development, review, and maintenance of statistical standard operating procedures (SOPs), Working Instructions (WIs), and internal guidelines
  • Familiarity with CDISC Standards, including SDTM, ADaM
  • Stay current with emerging statistical methodologies and evolving clinical trial practices

Requirements:

  • Masters degree or PhD in Biostatistics, Statistics, or related quantitative field, required
  • Minimum of 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum of 6 years for PhD-level candidates
  • Proficiency in statistical programming in SAS. Knowledge of R and other programming languages is preferred
  • Strong knowledge of statistical methodologies and clinical trial designs
  • Good understanding of CDISC standards (e.g., SDTM, ADaM) and their application
  • Experience with regulatory support and interaction
  • Experience providing statistical oversight of vendors and managing CRO collaborations
  • Proven ability to manage multiple studies and timelines concurrently
  • Excellent verbal and written communication skills, with the ability to explain statistical concepts to non-statisticians
  • Ability to work as a team and have skills to convince your position within cross-functional teams
  • Demonstrated ability to communicate statistical concepts and results clearly and effectively
  • Interest in and ability to learn clinical drug development processes
  • Able to work independently with minimum supervision

  • Cloud Migration Expert

    5 days ago

    Ghaziabad, Uttar Pradesh, India beBeeCloudMigration Full time US$ 1,50,000 - US$ 2,00,000

    Expert Cloud Migration SpecialistThis critical role requires a seasoned expert in cloud migration to oversee the onboarding and support of customers utilizing managed cloud services.Key Responsibilities:Lead the technical onboarding process for customers using managed cloud solutions.Collaborate with customers to understand their infrastructure requirements...

  • HCM Implementation Lead

    5 days ago

    Ghaziabad, Uttar Pradesh, India beBeeImplementation Full time ₹ 24,00,000 - ₹ 40,00,000

    Job Title: HCM Implementation LeadThis role requires an experienced professional with a strong background in Human Capital Management (HCM) to lead the implementation of HCM solutions.The ideal candidate will have a proven track record of successfully implementing HCM systems, covering the entire hire-to-retire cycle.Key responsibilities include:Leading...

  • SAP FICO Financial Transformation Lead

    3 hours ago

    Ghaziabad, Uttar Pradesh, India beBeeTransformation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Financial Transformation Expert WantedWe are seeking an experienced Financial Transformation Expert to lead finance initiatives within our organization. The ideal candidate will bring strong expertise in SAP FICO implementations, Product Costing, and treasury and finance reporting.Key Responsibilities:Lead end-to-end SAP FICO implementations and rollouts,...

  • YouTube Ads Marketing Expert

    2 weeks ago

    Ghaziabad, Uttar Pradesh, India Lotus Interworks Full time

    Job Title: YouTube Ads / Video Marketing ExpertLocation: Remote Employment Type: Full-Time Experience Required: Minimum 3–4 years in YouTube Ads & Video Marketing (B2B preferred)About UsWe are a fast-growing marketing solutions provider helping small and medium businesses in the USA achieve measurable growth through innovative digital campaigns. We are now...

  • Security Training Lead

    2 days ago

    Ghaziabad, Uttar Pradesh, India beBeeCybersecurity Full time ₹ 20,00,000 - ₹ 25,10,000

    About Us:We are a leading edtech company dedicated to empowering professionals with industry-relevant, practical, and cutting-edge technology training. Our goal is to bridge the skill gap through expert-led, hands-on learning experiences.Job Opportunity:We are seeking an experienced Cybersecurity Expert to lead and deliver engaging, hands-on training...

  • Solution Architect Lead

    3 hours ago

    Ghaziabad, Uttar Pradesh, India beBeeApplication Full time ₹ 15,00,000 - ₹ 20,00,000

    Job Title: Solution Architect LeadWe are seeking a seasoned expert to lead our application support team.The ideal candidate will have strong experience in managing complex technical issues and ensuring seamless application performance. Providing end-to-end support for applications built on .NET or PHP.Troubleshooting and resolving application, database, and...

  • Supply Chain Solutions Expert

    5 days ago

    Ghaziabad, Uttar Pradesh, India beBeeSolution Full time ₹ 82,50,000 - ₹ 1,42,25,000

    Supply Chain Solutions ExpertWe are seeking an experienced and detail-oriented Supply Chain Solutions Expert with a strong understanding of Kinaxis Maestro/RapidResponse to join our team.This role requires a blend of technical expertise, strategic thinking, and excellent communication skills to deliver tailored solutions that address complex supply chain...

  • Electrical Design Lead

    2 hours ago

    Ghaziabad, Uttar Pradesh, India beBeeDesign Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Electrical Design Lead - Substation ExpertThis is a high-level position that oversees the development of electrical designs for substation projects. The ideal candidate will have a strong background in electrical engineering, with experience in designing primary and secondary electrical systems.Responsibilities:Develop and implement electrical design plans...

  • Expert SAP Implementation Lead

    1 day ago

    Ghaziabad, Uttar Pradesh, India beBeeLeadership Full time US$ 1,50,000 - US$ 2,00,000

    SAP Project Management OpportunityWe are seeking a seasoned SAP professional to lead the planning, execution, and delivery of implementation and upgrade projects.Key Responsibilities:Manage end-to-end project lifecycle for implementations or enhancements.Strong understanding of SAP platform and lifecycle functionality, including implementation, upgrade, and...

  • Sales and Distribution Solutions Expert

    14 minutes ago

    Ghaziabad, Uttar Pradesh, India beBeeApplication Full time ₹ 1,50,00,000 - ₹ 1,80,00,000

    About the Role:As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact.This is a key position that requires leadership skills, technical expertise, and strong communication abilities.You will oversee the application development process and ensure successful project delivery.The...