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Senior Statistical Programmer
PHASTAR
posted 15d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- 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
- SAS Programming Experience within the pharmaceutical industry
- Good awareness of clinical trial issues, design, and implementation
- Experience of regulatory submissions and associated industry guidance
- Familiarity with GCP and regulatory requirements
- Knowledge of SDTM and ADaM CDISC standards
Employment Type: Full Time, Permanent
Read full job description What people at PHASTAR are saying
Rating based on 1 Senior Statistical Programmer
review
Anonymous · Research & Development
Likes
There is nothing to say good in organisation
Dislikes
There are many many things we can include to say bad . Work culture No proper KT Work life balance
- Salary - Bad+6 more
Senior Statistical Programmer salary at PHASTAR
reported by
1
employee
with 4
years exp.
₹19.8
L/yr - ₹25.3
L/yr
18%
more
than the average Senior Statistical Programmer Salary in India
View more details
What PHASTAR employees are saying about work life
based on 6 employees
Flexible timing
Monday to Friday
No travel
PHASTAR Benefits
View more benefits
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