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, therefore we are looking for an experienced, ambitious and driven Programmer to join our FSP team The expectation is that the candidate has very strong CDISC knowledge. We're looking for a skilled QC expert with strong experience in ADaMs and TLFs, along with solid SDTM knowledge. This role requires independent work, client coordination, and proactive problem-solving.

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 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

Qualifications :

Technical Skills:

• Proficiency in SAS (Macros, Base, Graphs) and other statistical Programming tools.
• Experience with CDISC Standards (SDTM, ADaM) and regulatory submissions.
• Knowledge of Statistical methodologies used in clinical trials.
• Understand Clinical trial data very well.
• Strong understanding of clinical trial data flow, from raw datasets to submission-ready formats.
• Experience with multiple therapeutic areas – so should have worked on a few Tas
• Implements new ways of working utilizing a wide variety of software (e.g. SAS, R, Python).
• Strong production hands-on TFL programming skills for in-house projects.
• Have to have worked on Disclosure tables especially the Basic Results tables.
• Quick learner as if they don’t have experience with Disclosure then at least they should be willing to learn.

Leadership and Management Skills:

• Serve as Lead Statistical Programmer overseeing programming deliverable across different Phases.
• Demonstrated ability to work and influence across functions, regions and cultures.
• Excellent communicator, able to convey both complex ideas and data, verbally and in writing.
• Recommends strategic decisions that impact the statistical programming function.
• Accountable for statistical programming decision making within study level.
• Plan, Prioritize, and allocate resources to meet project deadlines and regulatory submission timelines.
• Lead the development, validation, and implementation of standardized programming macros, templates, and best practices to improve efficiency.
• Collaborate with biostatisticians, data managers, and clinical teams to define data analysis requirements and ensure alignment with study objectives.
• Take ownership of statistical programming workflows, proactively identifying risks and mitigation strategies.

Communications:

• Excellent oral and written communications skills.
• Comfortable challenging the status quo and proposing forward thinking innovative solutions.
• Proposes and embeds ideas around innovative solutions and leverages new ways to accelerate existing milestones.
• Inspire teamwork.
• Assess benefit risk of options.
• Focuses on priorities.
• Strong interpersonal skills.
• Strong project management and time management skills.
• Strong collaborative skills and ability to work with a cross-functional team.

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!

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.