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Glenmark - SAS Programmer

2 months ago

Navi Mumbai, India Glenmark Pharmaceuticals Ltd Full time

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 world's top 100 biopharmaceutical companies (Top 100 Companies Ranked by Pharmaceutical Sales, 2020, by In Vivo/Scrip 100) and among the world's top 50 companies in the offpatent 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 world's most respected and widely accepted sustainability benchmarks, under the category of emerging markets (2021) for the fourth consecutive year.

INNOVATIVE MEDICINES GROUP :

- Innovation continues to be a key growth driver for Glenmark.

- In order to increase our focus on the in-house discovery and development of novel molecules, we have created a distinct sub-group within Glenmark called the "Innovative Medicines Group".

- Through this division, we will continue the development of innovative therapies to address critical
unmet medical needs and to improve the lives of patients and their families with serious diseases.

- Our current specialty pipeline consists of two respiratory molecules in various stages of clinical development, 1 molecule each in the therapy areas of pain and oncology.

- Each of these molecules has the potential to improve patient outcomes by proving to be safer and more effective than currently available0therapies.

POSITION DETAILS :

Designation : SAS Programmer (Multiple roles across level)

Business Unit : Research & Development

Function : Global Clinical Research Operations

Location : Mahape

Reporting to : Manager/Senior Manager - SAS Programming

ROLE OVERVIEW/ PURPOSE :

- Perform all Bio-statistical and SAS programming activities

- 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.

DESIRED EXPERIENCE AND KNOWLEDGE :

Educational Qualifications :

- Bachelor or Master Degree required, any statistics/bio statistics degree preferred, but not required

Experience :

- 2 -6 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 :

Role Summary :

1. SAS Programmer :

a. At least 1+ years of experience within clinical SAS Programming working with SDTM and ADAM

b. Candidate should be well versed with the SDTM, ADAM and TLG

c. Role will be based out of Mumbai

d. 5 day working from office, no remote or hybrid

(ref:hirist.tech)