Key Facts

Remote From:

Full time

English

Hard Skills

SAS (Software) Biostatistics SAP Implementation Regulatory Compliance Sample Size Determination Clinical Data Analysis Missing Data Stakeholder Communications Process Analysis Clinical Trial Planning Project Documentation Simulation Software Clinical Study Design Bayesian Statistics Statistical Modeling Meeting Facilitation

Other Skills

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Adaptability
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Communication
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Teamwork
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Critical Thinking
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Detail Oriented
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Prioritization
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Relationship Building

Roles & Responsibilities

PhD or MSc in Biostatistics/Statistics or a closely related field
Pharmaceutical industry experience with understanding of clinical trial design and implementation
Strong statistical knowledge in analysis of binary and continuous data, including missing data handling
Experience writing SAPs and protocols

Requirements:

Program and validate complex primary efficacy datasets and related tables, listings and figures per the SAP
Liaise with clients to propose alternative or additional analyses and develop macros for statistical analyses and figures
Write and QC SAPs, protocols, ISS/ISEs, DSMB charters and related documentation; provide statistical consultancy at design stage or program development; QC of sample size calculations
Serve as unblinded DSMB statistician, coordinate interim analyses, communicate findings to stakeholders and lead clinical interpretation meetings

Phastar

Research

About Phastar

Phastar is a specialist biometrics contract research organization offering statistical consulting, clinical trial reporting, data management and data science services by providing expert consultants and managing and delivering in-house projects, FSP-style arrangements and preferred partnerships. Our number one priority is ensuring on time, quality work: every project undertaken is supervised on methodology and utilizes internal processes designed to guarantee optimal quality, inspired by 4,000 years accumulated technical experience across the company. Phastar is headquartered in London (UK) and North Carolina (US) and has 15 offices worldwide

Company type: Large

Industry: Research

Founded: 2018

Company size: 201 - 500

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Job description

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 an experienced Statistician to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients, at either Senior or Principal level. We are looking for someone who is bright, adaptable – an individual that possesses excellent communication and relationship building skills.

The successful candidate will focus on GI or Oncology studies. The position will be full-time and fully remote (although it can be office/hybrid based, depending on the successful candidate's location).

Responsibilities:

The successful candidate may perform some or all of the following…
• 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 closely related field
• Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design, and implementation

• Solid statistical knowledge and capability in statistical analysis (e.g. binary and continuous data analysis, missing data handling, etc.)

• Experience in novel study design, Bayesian statistics, or complex statistical analysis/modeling/simulations is a plus

• Experience of writing SAPs, protocols
• Critical Thinker
• Previous experience working as a Lead Statistician
• Proficient in SAS
• Ability to work independently and collaboratively in a fast-paced environment

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!

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.

Ready to apply?

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