Job Description

Overview:
THE COMPANY
Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK.
Our unique approach to data analysis, "The Phastar Discipline", has led us to build a reputation for outstanding quality. With this as our core focus, we're looking for talented individuals who share our passion for quality and technical expertise to join our team.
WHY PHASTAR
Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment.
What's more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you'll also be helping to save the planet!
THE ROLE
Demand for our Functional Service Provision is growing - we are therefore looking for a driven and passionate Statistical Programmer to join our reputable FSP team to support one of our fantastic US based pharmaceutical clients. We are looking for an experienced Programmer with Strong hands-on experience across the full programming spectrum including SDTM, ADaM, TLFs, and P21 validation.
This is a fantastic opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within a pharmaceutical environment.
This position is remote, and the successful candidate can be located anywhere in India.
Responsibilities:
Responsibilities:
Employees may be required to perform some or all of the following...
Program and validate SDTMs and ADaMs, including complex efficacy, labs, etc.
Program complex non efficacy outputs/figures
Develop and debug complex macros
Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies
Review simple 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
Become familiar with and follow study documentation
Ensure the principles in the Phastar checklist are followed rigorously
Archive study documentation following instructions in supplied SOPs
Act as a Lead Programmer, ensuring quality and timely delivery
Liaise with the Study Statistician and Project Manager regarding resourcing and deliverables
Assess and monitor study level resources
Point of contact for programming issues for the team, proactively ensuring everything is working cohesively
Persuade stakeholders to follow best practice within a trial
Assist in development of internal training courses Qualifications:
Qualifications:
Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
End-to-End Programming Expertise: Strong hands-on experience across the full programming spectrum including SDTM, ADaM, TLFs, and P21 validation. Submission experience is a plus, though not mandatory.
Must have proven experience in both safety and efficacy datasets. While there are no restrictions on therapeutic areas, efficacy experience is essential.
Looking for candidates who can manage complex tasks independently, demonstrate high levels of self-sufficiency, and contribute strategically to team goals.
APPLY NOW
With the world's eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We're committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.
Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in India as this role can be carried out remotely.
Phastar is committed to the principles and practices of equal opportunities and to encouraging 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, colour, 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.