Top MNC Hiring - Expert Biostatistician Navayuga Consultancy

10.0 - 17.0 years

16 - 25 Lacs

Kolkata, Mumbai, Chennai

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Select the apt sample size; collect data; perform the test; and develop TLG (tables, listings, and graphs); and finally, report the inference. Review of ADaM Specifications and TLGs. Develop statistical analysis plans (SAPs) in alignment with clinical protocols and regulatory guidelines (ICH, FDA, EMA). Perform and validate complex statistical analyses using SAS and R , ensuring accuracy and reproducibility. Provide statistical input into clinical study design, sample size calculation, randomization, and data collection strategies. Collaborate closely with Clinical, Data Management, Medical Writing, and Regulatory Affairs teams. Present and interpret statistical findings to non-technical stakeholders and contribute to publications or regulatory submissions (CSR, ISS/ISE, etc.). Lead or contribute to the development of standard operating procedures (SOPs), templates, and best practices. Mentor junior statisticians and provide peer review of statistical deliverables. Excellent written and verbal communication skills. Ability to manage multiple projects and priorities in a fast-paced environment. Location : Pan India Shift : General Shift

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Clinical SAS Programmer Glenmark Pharmaceuticals

13 - 18 years

30 - 45 Lacs

Navi Mumbai

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Job Description :SAS Programmer ABOUT GLENMARK Glenmark Pharmaceuticals Ltd. is an innovation-driven global pharmaceutical company with a presence across Specialty, Generics and OTC businesses. It focuses on the key therapeutic areas of respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities, 4 research and development centers, spread across 5 continents and operations in over 80 countries. Glenmark is ranked among the world's top 100 biopharmaceutical companies (Top 100 Companies Ranked by Pharmaceutical R&D and Sales, 2022, by In Vivo/Scrip 100) and among the world's top 50 companies in the Generics and Biosimilars (Top 50 Generics and Biosimilars Companies ranked by Sales, 2022, by Generics Bulletin/In Vivo). The company was listed on the Dow Jones Sustainability Index (DJSI), one of the world's most respected and widely accepted sustainability benchmarks, under the category of emerging markets (2021) for the fourth consecutive year. For more information, visit www.glenmarkpharma.com POSITION DETAILS: Business Unit: Research & Development Function: SAS Programming Location: Mahape, Navi Mumbai Reporting to: Sanjay Jankar, Sr. General Manager, Biometrics ROLE OVERVIEW/ PURPOSE Perform all Bio-statistical and SAS programming activities. OVERALL JOB RESPONSIBILITIES Develop CDISC related documentation ex aCRF, mapping specs. Be the lead programmers for the outsourced studies Develop Analysis Datasets and TLG for the internal studies Update project related documentation regularly. Provide support to data management /Clinical in developing listings or ad hoc reports as required. Other SAS programming related tasks assigned by line management. KEY RELATIONSHIPS/STAKEHOLDERS External Vendors Internal (other than Direct Reports) Data Management Team CRA DB Programmer Medical team DESIRED EXPERIENCE AND KNOWLEDGE Educational Qualifications Bachelor or Master Degree required, any statistics/biostatistics degree preferred Experience: 10-14 year's clinical trials in pharma or CRO. In depth SAS programming knowledge. Hands-on experience on multiple CDISC projects (10 or more studies) and Written Reviewers Guide with CDISC package. Working knowledge with SDTM/ADaM/XML Familiarity with statistical methods used for biomedical/pharmaceutical research required; Experience with clinical trials or pharmaceutical industry experience required Knowledge of current industry and regulatory submission practices, protocol designs, and terminology. Knowledge and Skills (Functional / Technical) Excellent SAS programming (Base SAS + Advance SAS + SAS STAT + SAS Graph) Proficiency in English language Good Interpersonal Skills Time Management Training and Mentoring Presentation Skills Adaptability Strategic Thinking Decision Making Comfort with Computer system usage Behavioral Attributes Team Player Other Requirements (License / Certification & Specialized Training) ICH-GCP

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