Senior Statistical Programmer

Job Title: Senior Statistical Programmer

Job Location: India

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Mid-Senior level

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

We are seeking a Senior Programmer to work 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.

This position is remote (although can be office based or hybrid, depending on your location) and will involve occasional travel to events throughout the year.

Responsibilities

• 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

Qualifications

Educated to BSc or above within Computer Science, Mathematics or a Science related discipline

5+ years of CDISC standards experience (i.e. programming SDTMs and ADaMs)

5+ years of SAS programming experience within the pharmaceutical/CRO industry (essential)

ISS/ISE Experience (essential)

Excellent communication skills

Good awareness of clinical trial issues, design, and implementation

Familiarity with GCP and regulatory requirements

Experience with eCOA is a plus.

Collect experience in PRO or outcomes data, if applicable.

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