Senior/Principal Statistician

PHASTAR; Deutschland; Remote; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A global biostatistics CRO is seeking a Principal Statistician to oversee CRM clinical trials. Responsibilities include programming and validating datasets, writing statistical analysis plans, and liaising with clients. Ideal candidates will hold a PhD or MSc in Biostatistics or related fields, possess pharmaceutical industry experience, and be familiar with GCP. This role supports a strong team environment, promoting quality and innovation in clinical trials.

Leistungen

Flexible working hours

Continuous training and development

Supportive work environment

Qualifikationen

• Educated to PhD or MSc in Biostatistics, statistics or a related discipline.
• Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design, and implementation.
• Familiarity with GCP and regulatory requirements.
• Experience of writing SAPs, protocols.

Aufgaben

• Program and validate complex primary efficacy datasets.
• Develop and validate macros for statistical analyses.
• Write statistical section of protocol for any study.
• Provide statistical consultancy at study design stage.

Kenntnisse

Statistical Analysis

Team Collaboration

Data Management

Communication

Ausbildung

PhD or MSc in Biostatistics, Statistics or related discipline

Tools

SAS

R

Jobbeschreibung

Overview

THE COMPANY

Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK.

Our unique approach to data analysis, “The Phastar Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team.

WHY PHASTAR

Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment.

What’s more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you’ll also be helping to save the planet!

THE ROLE

We are seeking a Principal Statistician to Work as a statistician on CRM (Cardio, Renal & Metabolic) clinical trials; producing and validating complex outputs to excellent quality whilst adhering to deliverable timelines. Producing and reviewing Statistical Analysis Plans (SAPs), protocols and other pertinent study documentation. Acting as lead statistician within a reporting team environment, being responsible for statistical aspects of reporting out study results. Working as a global lead statistician across multiple studies, overseeing more junior leads and supporting regulatory interactions. Preparing randomisation schedules and acting as the unblinded statistician on reporting teams. Acting as a statistical consultant to pharmaceutical or biotech companies. Excellent team work ethos, and willingness to help others. Potential to have line management responsibilities.

Responsibilities

• Program and validate complex primary efficacy datasets
• Program and validate complex summary tables, listings and figures, program statistical analysis tables, according to the SAP
• Liaise with clients to propose alternatives or additional analyses if needed
• Develop and validate macros for statistical analyses and figures
• Perform stage 3 QC
• Advise on complex analyses and endpoints; ensure consistency across clinical trial program
• Create, validate and QC of efficacy dataset specifications for single studies, ISS/ISEs, etc
• Write ISS/ISE SAPs; DSMB SAPs and Charters
• Write project level or therapeutic area level documentation
• Perform QC of SAP text and develop standard SAP text and templates to be used within the company
• Identify the need and provide review of new standards and project level shells ensuring consistency across clinical trial programs
• Write statistical section of protocol for any study
• Provide statistical consultancy at study design stage or during program development
• Conduct independent critical protocol review
• Consult with clinical scientists to decide on best approach for sample size calculation, and execution
• Perform QC of sample size calculations
• Perform complex simulations
• Create complex randomisation schemes and QC of complex randomisation schemes
• Work as unblinded DSMB statistician involved with liaising with committee members
• Distribute and communicate interim analyses to appropriate stakeholders
• Attend meetings as the independent statistician on the DSMB committee
• Coordinate and lead clinical interpretation meetings
• Complete clinical trial transparency forms and input into project level regulatory documentation
• Senior review of CSR
• Archive study documentation following instructions in supplied SOPs
• Prioritise quality in all activities undertaken, by ensuring the principles in the Phastar checklist are followed
• Create, review and update processes and SOPs, identify areas where new processes are required

Qualifications

• Educated to PhD or MSc in Biostatistics, statistics or a related discipline
• Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design, and implementation.
• Familiarity with GCP and regulatory requirement
• Experience of writing SAPs, protocols

APPLY NOW

With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.

Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in the UK as this role can be carried out remotely.

Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.

Important notice to Employment businesses/Agencies

Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.