Principal Statistical Programmer

7 months ago

Bengaluru, India PHASTAR Full time

Overview:
Work as a principal programmer 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.

**Responsibilities**:
Employees may be required to perform some or all of the following:

- 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
- Take responsibility for study compliance with SOPs and processes

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

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