Overview

We are seeking an experienced SAS and R programmer to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients, at Senior level. We are looking for someone who is bright, adaptable an individual that possesses excellent communication and relationship building skills.

The successful candidate will focus on oncology studies. The role will be full-time and fully remote and the successful candidate can be based anywhere in India.

Responsibilities

Employees may be required to perform some or all of the following:

- Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
- Program complex non efficacy outputs/ figures
- Perform Senior Review and Deliver QC of non- statistical output
- Develop and debug complex macros
- Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
- Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc
- Review more complex study design SAP without supervision
- Review all shells without supervision and provide feedback
- Knowledge, interpretation and implementation of current SDTM, ADAM standards
- Knowledge of FDA CRT requirements including define.xml and define.pdf
- Lead team and be responsible for creation of CRT packages
- Become familiar with and follow study documentation
- Lead a team for furthering programming development
- Ensure the principles in the PHASTAR checklist are followed rigorously
- Archive study documentation following instructions in supplied SOPs




- Act as a Lead programmer on multiple studies under same project, ensuring quality and timely delivery
- Liaise with Study Statistician and Project Manager regarding resourcing and deliverables
- Responsible for study level resources
- Attend and input to company resourcing meeting
- Point of contact for programming issues for the team, proactively ensuring everything is working cohesively
- Persuade stakeholders to follow best practice within a trial
- Develop and deliver company-wide training as and when required
- Create, review and update processes and SOPs
- Take responsibility for study compliance with SOPs and processes

Preferred Experience

Strong experience in SAS and R (R is essential)

Experience in oncology studies is essential

Experience with R Shiny is preferred

Full end-to-end experience in SDTM and ADaM programming is required

HEOR experience would be beneficial

Qualifications

Skills & Qualifications

Proficient in SAS or R programming within pharmaceutical or CRO environments

Bachelor's degree or higher in Computer Science, Mathematics, or a related scientific discipline

Solid SAS programming experience within the pharmaceutical industry

Good understanding of clinical trial design, conduct, and implementation

Familiarity with GCP and regulatory requirements

Experience working with CDISC standards (SDTM and ADaM)

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Programmer-SAS&R (India)
🏢 PHASTAR
📍 India