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PHASTAR

Compare

3.4

based on 6 Reviews

7 PHASTAR Jobs

Senior/Principal Statistical Programmer (Submissions)

PHASTAR

3.4

based on 6 Reviews

2-7 years

Kolkata, Mumbai, New Delhi + 4 more

1 vacancy

Senior/Principal Statistical Programmer (Submissions)

PHASTAR

posted 3d ago

Job Role Insights

Flexible timing

Key skills for the job

Cron Pharmacy Computer Science SAP CO Data Analysis Talent Acquisition

+ 4 more

Job Description

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

Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
Expertise of CDISC standards is a must for this position.
Experience with P21E tool is a must.
This is for the submissions team, so a solid understand of SDTM/ADaMs, how to run and read P21 reports and understanding the requirements of eCRT packages is a must.

Candidate is expected to be able to lead right away
Experience of programming to SDTM and ADaM standards
Must be a strong senior or entry level principal.
Experience with ISS/ISE. Submission experience.
Experience with leading studies.
Strong hands-on programming background. Good communication skills.