Senior Statistical Programmer

Phastar; India; Remote; INR 2.800.000 - 3.600.000; Vollzeit

Benefits dieser Stelle

Remote working

Flexible hours

Career development

Zusammenfassung

Phastar is seeking a senior programmer to drive clinical and non-clinical trial analyses with SAS, SDTM and ADaM expertise. You will produce complex datasets, validate outputs, and ensure quality within tight timelines.

The role emphasizes leadership, collaboration with statisticians and cross-functional teams. Applicants should have strong SAS programming, CDISC SDTM/ADaM experience and the ability to translate SAPs into analysis outputs.

Qualifikationen

• BSc in Mathematics, Computer Science or a related discipline.
• Strong experience in clinical trial statistics and SAS programming across Phase II/III.
• Hands-on expertise in SDTM, ADaM, TLF development and validation with CDISC standards.

Aufgaben

• Provide statistical leadership and advanced programming for trials.
• Lead and develop junior team members and promote best practices.
• Ensure compliance, quality, governance and timely delivery of submissions.

Kenntnisse

SAS programming

Statistical analysis

Team collaboration

Ausbildung

Bachelor's or MSc in Mathematics/Statistics/CS

MSc advantageous

Tools

CDISC SDTM

CDISC ADaM

SAS Macro language

Jobbeschreibung

Overview

Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. Good knowledge of of CDISC SDTM and ADaM implementation guidelines; producing, reviewing and updating complex data specifications; creating and debugging complex macros; understanding Statistical Analysis Plans (SAPs) and output shells for day to day programming activities. Excellent team work ethos, willingness to help others and learn new skills from working in a team environment.

This role is full-time and fully-remote. The successful candidate may be based in India.

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.
• Strong experience in clinical trial statistics and SAS programming, supporting Phase II/III studies across analysis, reporting, and regulatory submission activities.
• Hands-on expertise in SDTM, ADaM, TLF development and validation, with strong knowledge of CDISC standards and submission-ready deliverables.
• The successful candidate will have experience supporting regulatory submissions, including NDA/BLA, MAA, ISS/ISE, eCTD packages, define.xml, reviewers’ guides, and responding to regulatory authority queries.
• The ability to interpret protocols, SAPs, shells, and statistical specifications, translate requirements into high-quality analysis outputs, and identify issues proactively.
• Strong understanding of submission QC, traceability, data integrity, and programming best practices, including independent validation, macro usage, documentation, and adherence to SOPs.
• Proven ability to work independently with statisticians, programmers, data management, medical writing, and sponsor teams, manage timelines, communicate risks early, and deliver high-quality outputs under tight submission deadlines.
• MSc in Mathematics, Computer Science or a related discipline is advantageous.

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

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.