Clinical/Medical Research (Healthcare & Medical)
Full time
About the role
The Principal Statistical Programmer will act as the Statistical Programming Coordinator and may provide ongoing supervision of an assigned portfolio of projects to ensure timely and efficient completion of projects.
Responsibilities
Review a clinical study protocol with regards to Statistical Programming responsibilities.
Review and provide input to a Statistical Analysis Plan (SAP).
Review and provide input to Case Report Forms (CRFs) and External Data Review Transfer Agreements.
Interact with internal and external teams.
Work cooperatively with clinical study team members including but not limited to the Biostatistician, Data Manager, Project Manager, and Medical Writer.
Understand and enforce compliance with programming standards and data standards in the statistical programming team.
Program SDTMs, ADaMs, Tables, Figures, and Listings (TFLs) according to approved specifications.
Provide accurate programming time estimates and risk mitigation plans to Management or Project Team.
Minimum Qualifications & Experience:
Minimum Bachelor's Degree in Life Sciences, Computer Science, Mathematics, Statistics, or in a Quantitative/Analytical field.
A minimum of 8 years of experience in the Pharmaceutical Industry, CRO, or related experience using SAS programming in Clinical Studies including leading a Clinical Study or Project Programming Team.
Novotech is proud to offer a great workplace.
We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only one of the things that is important to them.
We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development programs.
We are looking for people who are passionate about working in clinical research and biotech, including people who identify as LGBTIQ+, have a disability, or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application.
We look forward to contacting you regarding your application.
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