Associate Director, Biostatistics

1 month ago

Cambridge, United States Proclinical Staffing Full time

Associate Director of Biostatistics - Permanent - Remote within US

Proclinical Staffing are partnered with a truly exciting Mid-Sized Global Pharma in their search for an Associate Director, Biostatistics.

Primary Responsibilities:

The business specialize across a diverse set of Rare Diseases with their work culminating in 9 products successfully approved and now hold a renowned pipeline of several upcoming submissions.

Skills & Requirements:

  • D. in Biostatistics, Statistics, or equivalent, with at least 5 years of experience in pharmaceutical biostatistics;
  • Proficient in SAS programming
  • Previous experience as a lead statistician for a compound.
  • Understanding of ICH GCP (International Council for Harmonisation - Good Clinical Practice) and general knowledge of industry practices and standards.
  • Familiarity with CDISC (Clinical Data Interchange Standards Consortium) standards, such as SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model), and CDASH (Clinical Data Acquisition Standards Harmonization).
  • Experience representing sponsors in meetings with US FDA and international regulatory authorities.
  • Experience in designing and conducting adaptive trials.
  • Possess excellent written and oral communication and presentation skills.

The Associate Director of Biostatistics' responsibilities will be:

  • Act as a representative of the biostatistics team in cross-functional meetings, driving the clinical development of drug candidates, and offering valuable input on clinical development plans.
  • Collaborate closely with Clinical Development, Regulatory, and Clinical Operations Expertise Areas to design well-structured and effective clinical trials.
  • Author statistical sections of clinical trial protocols while seeking guidance and input from internal and external experts.
  • Contribute to or develop statistical analysis plans to ensure robust data analysis.
  • Work collaboratively with Data Management, Clinical Development, and Clinical Operations teams to design electronic case report forms (eCRFs).
  • Provide expert statistical guidance throughout the ongoing trials to ensure accurate data analysis and interpretation.
  • Collaborate with Statistical Programmers to summarize and analyze trial data.
  • Draft ADS (Analysis Data Sets) and ad hoc analysis specifications.
  • Play a key role in preparing clinical study reports and other regulatory documents, such as DSURs (Development Safety Update Reports) and Briefing Documents.
  • Represent company in meetings with regulatory authorities, Key Opinion Leaders, partners, and other stakeholders.
  • Contribute to the development of scientific articles that summarize data collected in company's trials.
  • Participate in various activities and meetings to provide support to the Biostatistics and Development Team as required.
  • Offer statistical consultation to Research & Preclinical colleagues on their work.
  • Manage statistical and programming support from external Contract Research Organizations (CROs).

Compensation:

  • $205,000 to $215,000 per annum.

If you are having difficulty in applying or if you have any questions, please contact George Breen at g.breen@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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