Phastar
Website:
phastar.com
Job details:
Work as a principal programmer across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines working independently in this area; producing, reviewing and updating complex dataset specifications (including efficacy); creating and debugging complex macros; reviewing Statistical Analysis Plans (SAPs), including study specific ISS/ISE and DSMB SAPs and output shells with a view to commenting from a programming perspective. Excellent team work ethos, proactive at managing workload, willingness to help others and learn new skills from working in a team environment.
The role will be full-time and fully remote, the successful candidate will be based in India. The successful candidate's working hours will overlap with US working hours.
Responsibilities
The following areas of expertise will be aligned to the role...
- Statistical expertise and scientific leadership
- Leadership and people development
- Compliance, quality and governance
- Communication and influence
Qualifications
- BSc in Mathematics, Computer Science or a related discipline
- The ability to create, validate and maintain CDISC SDTM and ADaM datasets in compliance with regulatory submissions
- Proficiency in SAS (Macros, Base, Graphs) and other statistical Programming tools
- Experience with Define.xml, Reviewer’s Guide (SDRG, ADRG) and regulatory compliance documentation
- Relevant leadership experience
- Familiarity and experience with SDTM/ADaMs and TLFs
- Experience working on Integrated Summaries (ISS/ISE)
- At least 7 years of CDISC and Clinical trials experience
- eCRT experience is a must
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
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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.
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