Principal Biostatistician - Remote US - Leading CRO

Principal Biostatistician - Remote US - Leading CRO

Job Description:

A market-leading & well-established biopharmaceutical company, is in search for a Principal Biostatistician to assist their work on some complex oncology-focused clinical trials with the potential to save millions of lives.

The client is working across multi-stage clinical trials and are working on varied and complex projects in the pharma space. This is a role for someone who enjoys variety in their biostatistical work.

General Responsibilities

Provide to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts, and manuscripts to ensure that statistical elements are in line with leading-edge knowledge and the overall product strategy.

Lead the development of the statistical analysis plan for clinical trials and historical control comparisons

Provide specifications and directions to the statistical programmers in establishing standards for clinical conduct and data collection, management and/or reporting of data

Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results for CSRs / ISE / ISS

Provide guidelines and standards to CROs to ensure the quality of deliverables

Represent Biostatistics in meetings with cross-functional project teams ensuring adherence to FDA / ICH guidelines, Good Clinical Practices, and regulatory requirements

Contribute to interactions with external review boards/ethics committees, external consultants and key opinion leaders

Contribute in process development including writing SOPs and mentor junior members of the team

Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer-reviewed journals and presentations at professional meetings

Job Qualifications, Experience & Skills

2+ years of experience working in a Pharmaceutical Company or a Biotech or a CRO

Comprehensive knowledge and prior experience of advanced statistical methodology in clinical trials that apply to Phase I-IV clinical trials, adaptive study design, Bayesian analysis and regulatory requirements relating to clinical development of drugs.

Ability to initiate, drive and implement novel methods and innovative trial designs, including the development and review of study related documents (e. g. Statistical Analysis Plan, Statistical part of Study Protocols, Case Report Form, Data Management Plan, IDMC Charter)

Profound knowledge of statistical software "Base SAS", "SAS Macros", "Addplan" and "R" Extensive knowledge of industry standards, such as the ICH guidelines, CDISC standards / implementation guides, 21 CFR Part 11, and FDA guidelines

Expertise in medical research, especially oncology and inflammatory diseases

Experience in calculating the probability of study success, modelling and simulation

Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure and in a team environment to meet established deadlines

Experience in working in matrix organizations

Team player with well-developed interpersonal abilities

Excellent written and oral communication skills in English, including grammatical/technical writing skills

How To Apply

AL Solutions is a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you re interested, please apply below. If this position doesn t interest you, please visit our website for a list of more vacancies.

Kallum Saleem

AL Solutions

Tel: (0) - & ask to speak with Kallum