Overview:

Overview

We are looking for an experienced Senior Statistical Programmer with strong expertise in SAS, R, and Oncology clinical trials to join our growing team. This is an excellent opportunity to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients.

The role will be full time and fully remote and the successful candidate can be based anywhere in the 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

Key Requirements

The following areas of expertise will be aligned to the role...

Extensive hands-on SAS programming experience (5+ years) in clinical trials

R programming (intermediate to advanced level) with at least 1–2 years of practical experience.

Experience in Oncology clinical trials.

Strong knowledge of CDISC standards, including SDTM,ADaM,Define.xml,Reviewer's Guide

Pinnacle 21 (P21)

Experience supporting regulatory deliverables and clinical study programming.

Excellent written and spoken English.

Qualifications:

Preferred Skills

- Experience with R Shiny (or willingness to learn quickly).
- Project or technical lead experience.
- Experience with programming automation and process improvements.
- Regulatory submission experience.
- Ability to work independently with a proactive approach.
- Strong technical problem-solving skills and experience leading programming activities.

Why Join Us?

- Remote working and flexible working hours
- Career development, mentorship, and continuous learning
- Supportive, friendly, and collaborative culture

About Phastar

Phastar is an award-winning biometrics and data science CRO, trusted by pharma, biotech, and medical device companies worldwide. With a global team of data specialists, we bring expertise, precision, and pace to every trial, because behind every data point is a patient waiting for treatment. We transform complex data into clear, actionable intelligence, helping accelerate drug development,



and bring life-changing therapies to patients faster.

Awards & Recognition

- SCRIP – Best Contract Research Organization, Specialist Provider
- Citeline – 2025 Award Winner
- Fierce CRO Awards – Recognized Industry Leader

Apply Now

Be part of a team known for technical expertise, quality, and impact. We value Excellence, Collaboration, Integrity, Innovation, and Passion—and we seek team members who embody these qualities. Apply today!

Phastar is committed to the principles and practices of equal opportunities and to encourage the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, color, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.

Important notice to Employment businesses/Agencies

Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

📌 Senior Programmer (India)
🏢 PHASTAR
📍 India