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Director, Biostatistics - REMOTE

Employer
Proclinical Staffing
Location
Homeworking
Salary
Highly Competitive Salary
Start date
13 Mar 2023
Closing date
27 Mar 2023

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Job Details

Proclinical is seeking a remote Director, Biostatistics for a leading biotech company. This position will provide Biostatistics support for one or multiple therapeutic areas to ensure that Company Research and Development projects are correctly designed, properly analyzed, and clearly presented to support new product development, domestic and international regulatory submissions.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

  • Directs and controls the activities of Biostatistics to support one or more therapeutic areas to ensure clinical programs are optimally designed, properly analyzed, and clearly presented to support new product development, domestic and international regulatory submissions
  • Supports the establishment and maintenance of policies, standards, and procedures for global Biostatistics
  • Leads in development and adaptation of new statistical methodology in support of research and development, keeping current with regulatory guidance and requirements in the global environment
  • Provides statistical consultations for cross-functional teams within the company.
  • Provides statistical inputs in the development of study protocols, provides sample size estimates and power calculations, and oversees generation of randomization schedule
  • Hires, mentors, and manages employees or consultants to maintain a competent and qualified staff
  • Contributes to the selection of qualified and cost-effective CRO's to supplement internal resources. Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results. Provide guidelines and standards to CROs to ensure quality of deliverables
  • Demonstrated ability to provide coaching and feedback to foster professional development while also supporting business goals
  • Collaborate with members of project teams to establish project timelines and to develop and implement protocols
  • Develop or reviews statistical analysis plans (SAPs) to meet regulatory standards, coordinate and perform data analysis and validation as necessary, and provide data interpretation
  • Coordinates data and TFL review activities among the project team members
  • Reviews study protocols, CRFs, Data Validation Specifications (DVS), and other study-related documents to ensure correctness of statistical representation of data and results, and collection of required data
  • Writes or reviews specifications for datasets, tables, figures, listings, and consistency checks for both efficacy and safety analyses; performs validation of key statistical results
  • Develops or reviews templates for ISS and ISE statistical tables for regulatory submission in conjunction with clinical and provides specifications for production of ISS and ISE tables
  • Reviews ISS and ISE reports towards regulatory submission
  • Provides input in preparation of study reports, with particular emphasis on the statistical methods section, and works closely with Medical Writing in study report preparation
  • Responds to questions from the FDA and other regulatory authorities or ethics committees on statistical issues
  • Collaborate with clinical scientists, thought leaders, and medical writers, both internally and externally, in the publication of study data. Leads statistical analysis for publications
  • Stay current with new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc.
  • Other duties as assigned

Skills and Requirements:

  • PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with at least 6 years of relevant work experience OR a Master's degree in Statistics or Biostatistics or a related health science field, and at least 8 years of biostatistical experience in the clinical trials or health research environment
  • Comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics
  • Familiarity with pharmacokinetic/pharmacodynamic data is a plus
  • Experience supporting publication of analysis results (e.g. abstracts, posters, manuscripts)
  • Demonstrates knowledge of industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines
  • Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies
  • eCTD BLA/NDA experience and/or preparation of MAA
  • Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS. Capable of providing sample SAS codes for statistical analysis procedures and perform independent QC for critical outputs
  • Requires understanding of the company's products, the competition, and the pharmaceutical industry in general
  • Maintains current awareness of new drug developments in the business

If you are having difficulty in applying or if you have any questions, please contact Paula Bonilla at (+1) 305-929-0913 or p.bonilla@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.

#LI-PB2

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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