Job Description

The Principal Statistical Programmer (PSP) is primarily responsible for all statistical programming aspects, and/or acts as Lead Programmer, across several studies. The PSP 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 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.
• Work cooperatively with the statistical programming study team members ensuring on-time delivery and quality standards of outputs.
• Assist Management team to assign tasks, set priorities, and provide technical help to junior statistical programmers.
• Develop and maintain SDTM and ADaM specifications.
• Program SDTMs, ADaMs, Tables, Figures, And Listings (TFLs) according to approved specifications.
• Understand and enforce compliance with programming standards and data standards in statistical programming team.
• Provide accurate programming time estimates and risk mitigation plans to Management or Project Team.
• Proactively inform management of the status of Statistical Programming deliverables and issues.
• Define strategies and evaluate the statistical resources needed to meet the defined project team goals.
• Serve as formal mentor to assigned Statistical Programmers.
• Ensure compliance with applicable regulatory agency guidelines and Novotech SOP’s in study design, protocol development and all other statistical programming output.
• Represent Novotech at client meetings.
• Participate in activities of the Biometrics department, including participation in industry forums (conferences, professional association committee work etc.) and providing training on Statistical programming related topics to Statistical team and wider Novotech organisation.
• Act as subject matter expert (SME) and contribute to process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.

Minimum Qualifications & Experience

• Minimum Bachelor’s Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or in Quantitative/Analytical field.
• A minimum 8 years of experience in pharmaceutical industry, CRO or related experience using SAS programming in clinical studies including leading a clinical study or project programming team.
• Able to independently perform technical work and oversee a statistical project programming team.
• Exceptional SAS programming skills; contribute programming to a global library of macros.
• Advanced knowledge of CDISC standards and applying standards to different study phases, study designs and therapeutic areas.

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 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