Principal Statistical Programmer -Remote India

About the job

About Phastar

Phastar brings data to life! We are an award-winning specialist biometrics contract research organization (CRO) that works with pharmaceutical, biotechnology and medical device companies to provide statistical consulting, analysis and reporting, data management, and data science services.

Our unique approach to data analysis, The PHASTAR Discipline, has gained us a reputation for outstanding quality. With this as our core focus, were looking for a talented individual who shares our passion for quality and technical expertise to join our teamcould this be you?!

Why Phastar

Phastar is a company that cares. We strive to be the premier biometrics provider to work with, and to work for, and we take our responsibility to do our part for the environment and our community seriously.

Our pro bono scheme provides charities access to our biometrics experts at no cost; we source sustainable products to reduce our carbon footprint and, when you join our team, we will plant a tree in your honour as part of our rewilding project. Learn more about our ESG initiatives here.

Caring for YOU

YOUR career, YOUR work/life balance, YOUR PHASTAR experience.

Total flexibility working hours that work for YOU.

Remote working arrangement that works for YOU.

Culture of learning continuously develop YOUR knowledge and share YOUR expertise with others.

Career Path - tailored to YOUR strengths and aspirations.

Monthly well-being checks to ensure you get the support you need.

Fun, friendly working environment experience PHASTARs famous social events throughout the year.

Sound a good fit for you? Here are some of the key contributions you would be making as a fully integrated member .

• 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
• 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
• 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 require

QUALIFICATIONS EXPERIENCE

BSc or above in mathematics, science, or IT related discipline.

Experience working on clinical trials within a CRO/pharmaceutical environment.

Ability to engage and interact with global and local teams, embedding into the client teams

Proactive and solutions orientated

Oncology experience preferred but not mandatory

Demonstrable leadership skills including providing oversight of deliveries

Excellent proven end to end programming experience including SDTM, ADaM and TLFs with solid experience of validating/reviewing outputs

Please use the below link for job application and quicker response.

https://lifelancer.com/jobs/view/e0c2daf652dc3064744551bc715ca1de