Director/ Associate Director
Biostatistician

Netherlands \

East coast, US

About the position:

The Associate Director/Director, Biostatistics will be responsible for designing, implementing, and reporting in a quality, timely and accurate manner, the statistical processes in the clinical trials, including applying state of the art concepts and tools to the interpretation of clinical trial data when appropriate. The candidate must have the demonstrated ability to work independently, be detail-oriented, have excellent communication skills and ability to work remotely across multiple time zones in a global environment

Professional qualifications:

  • PhD or MSc in Biostatistics or Statistics required.
    At least five (5) years’ experience for PhD, or eight (8) years’ experience for MSc as biostatistician in the Pharmaceutical or Biotechnology industry, and specifically with analysis of clinical data

  • Excellent working knowledge of CDISC requirements for regulatory submissions, including expertise with preparation and submission of data in STDM, ADaM, and SEND data standards and associated documentation.

  • Proficient in SAS programming and at least one other programming language

  • Proficient at Excel including graphics

  • Ability to interpret statistical concepts and results

  • Prior experience with FDA (and EMA – preferred) submissions including SAPs for pivotal trials and/or NDA submissions

  • Able to thrive in a fast-paced, collaborative environment, working remotely across multiple time zones

  • Self-starter who thrives in an entrepreneurial environment

  • Consistent attention to detail

  • Excellent interpersonal skills: ability to understand and respond to multiple external and internal customers’ demands, manage and handle conflict constructively required.

Roles and Responsibilities:

  • Responsible for providing statistical input into all phases of clinical development (ensuring regulatory compliance and compliance with good statistical practice) and providing statistical input into the reporting of clinical trial results e.g. in CSRs, manuscripts, regulatory submissions, and presentations to conferences.

  • Produce and deliver statistical analysis strategy for clinical development programs, endpoint strategy, statistical analysis plans (SAPs), reports and manuscripts, and statistical analysis required to support development program, including shells for tables, listings and figures.

  • Analyze clinical and preclinical data and produce accurate results that represent the outcome of the trial, validate statistical outputs, and accurately interpret and clearly communicate statistical results and concepts to non-statisticians.

  • Perform ad hoc and exploratory statistical analyses as needed.

  • Assist in writing relevant sections of the clinical study report and publications

  • Contribute to the planning and delivery of key analytical or clinical components of regulatory submissions, including but not limited to Q-subs, PMA, and sPMA.

  • Collaborate with external vendors as needed, including company’s external biostats consultants.

Location/Time/travel:

  • This is a full-time remote position in the East Coast of United States

  • Flexible schedule with interactions across Israel, North America and Europe time zones

If you wish to apply for this position, please email your CV to