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Principal Statistical Programmer

2 weeks ago

Remote, India PHASTAR Full time

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

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.

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

- Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
- Become independent technical expert
- Program complex non efficacy outputs/ figures
- Perform Senior Review and Deliver QC of non
- statistical output
- Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
- Validate and perform User Acceptance Testing (UAT) on standard macros
- Identify macros requirements, communicate and perform training
- Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc
- Implement and coordinate development and maintenance of PHASTAR standard specifications
- Be an SDTM and ADAM expert providing consultancy, advice and training
- Be an CRT expert providing consultancy, advice and training
- Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements
- Implement and coordinate the development and maintenance of PHASTAR CRT tools
- Become familiar with and follow study documentation
- Initiating projects and ideas for furthering programming development
- Ensure the principles in the PHASTAR checklist are followed rigorously
- Develop archiving systems and processes
- Act as a Lead programmer on multiple studies and 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
- Identify areas where new processes are required
- Create, review and update processes and SOPs
- Take responsibility for study compliance with SOPs and processes

Qualifications:

- BSc or above in mathematics, science, or IT related discipline.
- Experience working on clinical trials within a CRO/pharmaceutical environment.
- Excellent proven end to end programming experience including SDTM, ADaM and TLFs with solid experience of validating/reviewing outputs
- Strong QC ability across ADaMs and TLFs predominantly but good SDTM experience needed
- Ability to work independently and link in with client for work assignments, updated FSP manager on progress/timelines/challenges and feedback QC comments to third party vendor
- Must be able to work autonomously as there is no overlap with client teams based in US for day-to-day communication. Has to feel comfortable prioritising tasks and being able to investigate issues and suggest solutions

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 employ