Lead Statistical Programmer - Sponsor Dedicated

Fortrea; Thatcham; On-site; GBP 60,000 - 75,000; Full time

Job summary

A global CRO is seeking a Lead Statistical Programmer to oversee programming activities in clinical trials. This role involves collaborating with study teams and mentoring junior staff. Candidates should have over 5 years of relevant experience and be proficient in SAS. The position offers the flexibility to work from home or local offices in EMEA.

Qualifications

• 5+ years of experience in statistical programming within clinical trials.
• Solid understanding of CDISC requirements related to SDTM and ADaM.
• Fluent in English - both verbal and written.

Responsibilities

• Plan and oversee programming activities on studies.
• Mentor less-experienced team members.
• Ensure quality standards in statistical outputs.

Skills

SAS programming

Statistical analysis

Clinical trial knowledge

Communication

Education

Degree in mathematics, life sciences, statistics, or computer sciences

Tools

SAS

Job description

Overview

As a Lead Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex projects for a renowned, innovative and global top pharmaceutical company.

You will be involved in liaising with the entire study team as needed, including Clinical, Medical Writing, Safety and Biometrics. It is a great opportunity to see more how this works from a Big Pharma perspective, whilst still being part of a global CRO with opportunity for future career growth.

You can be 100% home-based in EMEA or, if you prefer, you can work from our local office in your home country.

Responsibilities

• Plan, execute and oversee all programming activities on a study, including but not limited to: resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments, etc.
• Oversee SDTM, ADaM and TLF development, perform Senior Review of outputs.
• Liaise with other Sponsor departments for additional programming needs, as required to support publications, medical writing and additional development needs and analyses.
• Support/oversee submission activities (especially in late phase team).
• Ensure all activities are conducted efficiently, with appropriate set-up of needed tools and macros, prioritizing quality at all times.
• Mentor less-experienced team members in best practices around SDTMs, ADaMs and TFLs while ensuring adherence to department standards and processes.

Your Profile

• Ideally, a degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
• In lieu of the above: professional experience in statistical programming within clinical trials in a biotech, CRO or pharmaceutical company.
• Solid experience with complex clinical trials (minimum 5 years) and the corresponding datasets’ content (safety and efficacy) and endpoints.
• Previous Lead experience preferred.
• Ideally you will have knowledge in all aspects of clinical trials, from initial study set-up to study completion, with an understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management.
• Expert knowledge of base SAS, SAS macros, SAS/STAT and in debugging SAS programs.
• Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer\'s Guides and submission standards.
• An autonomous, collaborative work style, a curious mind and a keen attention to detail.
• Fluency in English - both verbal and written - is a must.

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