Clinical Sas Programmer

Job Description Clinical SAS Programmer

ABOUT GLENMARK
GLENMARK PHARMACEUTICALS
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 10 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries. Glenmark is ranked among the worlds top 100 biopharmaceutical companies (Top 100 Companies Ranked by Pharmaceutical Sales, 2020, by In Vivo/Scrip 100) and among the worlds top 50 companies in the off- patent sector (Top 50 Generics and Biosimilars Companies ranked by Sales, 2020, by Generics Bulletin/In Vivo). The company was listed on the Dow Jones Sustainability Index (DJSI), one of the worlds 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
Designation: Clinical SAS Programmer

Business Unit: Research & Development
Function: Global Clinical Research Operations
Location: Mahape
Reporting to: Manager/Sr. Manager SAS Programming

ROLE OVERVIEW/ PURPOSE
Perform all Bio-statistical and SAS programming activities

OVERALL JOB RESPONSIBILITIES
• Develop CDISC related documentation ex aCRF, mapping specs. Make sure that document/Datasets are in
compliance with CDISC and drug agencies submission requirements.
• Be the lead programmers for the outsourced studies. Ensure projects timelines are met. And deliverables are
in accordance with internal and CDISC standards.
• Develop Analysis Datasets and TLG for the internal studies. Review the SAP and provide comments to the
statistician. Develop the programs and outputs in accordance to the internal SOP.
• Update project related documentation regularly. Project related documentation to be up-to-date. Ensure that
the project documentation is maintained adequately in the DM/Stat Binder.
• Provide support to data management /Clinical in developing listings or ad hoc reports as required. Ensure that
various listings are developed for the project as required.
• Other SAS programming related tasks assigned by line management. Ensure that all tasks assigned by the
functional manager are completed within time and with appropriate quality.

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/bio statistics degree preferred, but not required

Experience
• 6-12 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
• Other Requirements (License / Certification & Specialized Training)
  • ICH-GCP