Lead Statistical Programmer - Sponsor Dedicated

Fortrea; Maidenhead; Remote; GBP 45,000 - 70,000; Full time

Job summary

A global top pharmaceutical company is seeking a Lead Statistical Programmer in Maidenhead. You will oversee programming activities for clinical trials and mentor team members. The ideal candidate has a degree in a relevant field, at least 5 years of experience, and expertise in SAS. The position offers flexibility for home-based work or local office engagement.

Qualifications

• 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 corresponding datasets content.
• Expert knowledge of base SAS, SAS macros, SAS/STAT and debugging SAS programs.

Responsibilities

• Plan, execute, and oversee programming activities on a study.
• Oversee SDTM, ADaM, and TLF development.
• Liaise with Sponsor departments for programming needs.

Skills

Business Development

Customer Service

Data Analysis

Education

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

Tools

SAS

Job description

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 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.

Your Responsibilities

• Plan, execute, and oversee all programming activities on a study, including resource estimation, working within budget, meeting timelines, and maximizing quality interaction with other departments.
• Oversee SDTM, ADaM, and TLF development and 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 SDTM, ADaM, 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.
• 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 debugging SAS programs.
• Broad knowledge of all CDISC requirements related to SDTM and ADaM including Reviewers 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.

Key Skills

• Business Development
• Customer Service
• Attorney
• CISSP
• Data Analysis

Learn more about our EEO & Accommodations request here.

Employment Type: Full-Time

Experience: years

Vacancy: 1