SME, CDISC & eSubmission Standards (India)

SME, CDISC & eSubmission Standards (India)

01 Aug
|
Sun Pharmaceuticals
|
India

01 Aug

Sun Pharmaceuticals

India

Sun Pharma is looking for an experienced SAS Macro Developer to join our team. The primary responsibilities of this role will be to develop and maintain SAS macros to support our SDTM (Study Data Tabulation Model), ADAM (Analysis Data Model), and TLF (Tables, Listings, and Figures) programming efforts, which are critical components of the drug development process. Key Responsibilities: + Design, develop, and implement reusable SAS macros to streamline SDTM, ADAM, and TLF programming workflows + Collaborate with SAS programmers, Biostats and subject matter experts to understand business requirements and translate them into efficient macro solutions + Demonstrate a strong understanding of the drug development process and the role of SDTM, ADAM, and TLF standards in regulatory submissions + Develop macros to automate and standardize SDTM programming tasks, such as data transformation, variable derivation, and metadata generation + Maintain a valuable working knowledge of SDTM and ADAM standards to ensure macros are aligned with industry best practices + Optimize macro performance and ensure they are scalable and maintainable + Thoroughly test macros to validate functionality and identify/resolve any issues + Document macro code, usage, and best practices for knowledge sharing + Provide training and support to other team members on leveraging the developed macros + Stay up-to-date with the latest SAS macro language features and techniques + Will occasionally need support study team in with study SDTM/ADaM and TLFs Programming Qualifications + Education: BSc or equivalent with research experience,



and/or MS (Computer Science, Bioinformatics, or Related field). Masters Degree preferred. + Minimum 7 years of experience in SAS programming, with a strong focus on macro development in Clinical development with strong knowledge of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines + Experience in the pharmaceutical, healthcare, or life sciences industry is highly preferred + Experience with R programming is highly preferred Required Skills: + Proficient in writing complex, dynamic SAS macros using macro language features such as macro variables, macro functions, and macro conditional logic + Demonstrated understanding of the drug development process and familiarity with CDISC SDTM, ADAM, and TLF standards + Experience in designing modular, reusable, and maintainable macro solutions for SDTM programming tasks + Knowledge of Software Development Life(SDLC) cycle process + Strong problem-solving and analytical skills to identify and resolve macro-related issues + Excellent communication skills to collaborate with cross-functional teams + Ability to work independently and as part of a team We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

📌 SME, CDISC & eSubmission Standards (India)
🏢 Sun Pharmaceuticals
📍 India

Reply to this offer

Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.

Subscribe to this job alert:

Get the latest job offers by email for: sme, cdisc & esubmission standards (india) / india

Subscribe to this job alert:

Get the latest job offers by email for: sme, cdisc & esubmission standards (india) / india