Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.

Summary of the Position:

We are looking for a Statistical Programming Team Lead to join our Biometrics department. You will be based remotely in the UK/EU.

You will provide support to the Head of Programming by providing oversi ght on clinical studies, ensuring standards are maintained according to Simbec-Orion (and/or Sponsor) Standard Operating Procedures (SOPs) ICH-GCP guidelines to ensure the quality of the clinical data delivered to our sponsors is of the highest standard such that subjects' rights, safety and well-being are protected and is completed within the agreed project timelines .

You will lead the ir S tatistical Programming team through manag ing and mentoring, leading on process improvement activities and working towards best practice . You will identify training needs and provide technical leadership and support to the ir team .

Key Accountabilities:

• Manages the flow of work for allocated studies to ensure the scope of work, budget and timelines for all study - related activities are adhered to and flags potential changes in scope , database and programming issues to internal and external study teams and suggests resolutions.
• Produces and QCs datasets, tables, figures and listings using SAS, including routine statistical analys i s.
• Acts as the S tatistical P rogramming point of contact for both internal and external customers for allocated studies .
• Attends study team meetings throughout the life of the study to communicate issues that may affect the study.
• Provides solutions to issues that arise during the conduct and analysis of the study.
• Leads on process improvement initiatives within Statistical Programming and plays a key role in r eview ing and updat ing SOPs.
• Maintains knowledge of relevant regulatory guidance and requirements , i.e. GCP, MHRA, CDISC etc .
• Line manages and provides technical leadership, training and mentoring to the ir Programming team
• Provides in-house training, technical support and mentoring for colleagues.

Minimum Requirements:

Essential:

• Minimum A levels (or equivalent)
• Significant experience as a Statistical Programmer within the pharmaceutical industry or within a Clinical Research Organisation
• Knowledge of and experience with CDISC standards
• Experience in define-XML production and FDA documentation requirement
• Experience in working in multi-disciplinary teams
• Experience in training and mentoring colleagues
• Excellent written and verbal communication skills in Fluent English
• Excellent organisation and time management skills
• Excellent attention to detail
• Comprehensive knowledge of the C linical D evelopment process and its critical paths.

Desirable:

• Master's Degree Qualified in Statistics or overseas equivalent
• Previous experience of l eading or managing a Statistical P rogramming T eam
• Experience with Statistical Programming across Phase 1/II/III C linical T rials
• Awareness of the G lobal regulatory environment.
• Experience in a wide breadth of therapeutic areas.
• An understanding of clinical trial budgets
• Experience in Bid Defence Meetings, including preparatory and follow up meetings
• Experience in managing process improvement activities

Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.