Principal Biostatistician - East Coast

POSTED ON 11/26/2022 AVAILABLE BEFORE 12/7/2022
AL2S3 LTD Hired Organization Address Kasigluk, AK Remote Full Time

Job Posting for Principal Biostatistician - East Coast at AL2S3 LTD

Job Description:

George Higginson is pleased to be kicking off the winter of 2022 by offering an incredibly rare opportunity to be exclusively partnered with the market leading, commercial-stage biopharmaceutical company, in search for an experienced Principal Biostatistician.

The client currently has one FDA approved product on the market within B-cell lymphoma. In addition to this, x4 other products currently in Phase 3 trials, in their pipeline to date.

Since opening their U.S. office in Boston, they have doubled in size to supporting rapid growth, building teams of experts across a variety of different disciplines, from drug development to commercialization.

Job Summary & General Responsibilities

  • Provide input 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 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

  • Masters in Statistics or Mathematics with 3 years of experience working in a Pharmaceutical Company or a Biotech or a CRO or PhD in Statistics or Mathematics with 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 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

Health & Safety

Full vaccination is an essential requirement: (two weeks after completing the second dose of a two-dose COVID-19 vaccine e.g., Pfizer or Moderna or two weeks after receiving a single dose of a one-dose vaccine e.g., Johnson & Johnson/Janssen

Culture & Benefits

You will receive a comprehensive benefits package consisting of medical and dental, vision, life, disability and more. We offer a competitive PTO and holiday schedule – giving you the time you need to recharge, along with a 401k retirement plan which allows you the opportunity to save for your future with an employer matching program. Our culture is a collaborative work environment and we believe the unique contributions each of us brings drives our success.

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.

George Higginson

AL Solutions

george@alsolutions.co.uk

Tel: 44 (0) 203 778 0909

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