Principal/Senior Statistical Programmer

Principal /Senior -Statistical Programmer -Remote India

As an experienced programmer, you will hold a combined project leadership and hands-on technical statistics role. Working across a defined area within the sponsor team you will be leading studies and working on sponsor systems

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

Preferred:

• Supports the Statistical Programming Point of Contact in ensuring successful implementation of programming strategies and efficient execution of statistical analyses for assigned clinical projects.
• Applies technical knowledge and experience to deliver statistical programming outputs with minimal supervision, supporting study teams effectively.
• Ensures high quality and consistency in the development of analysis-ready datasets, tables, listings and figures (TLFs).
• Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Analysis Plans (SAPs), SDTM/ADaM specifications, datasets and TLFs.
• Provides limited oversight and guidance to FSP colleagues, as required.

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

Experience in SDTM and ADaM CDISC standards

Apply Now!

Be part of a team known for technical expertise, quality, and impact. We value Excellence, Collaboration, Integrity, Innovation, and Passionand we seek team members who embody these qualities.

Apply today!

Phastar is committed to the principles and practices of equal opportunities and to encourage the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, color, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.

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