Deciphera Pharmaceuticals Inc.

Job Title: Associate Director of Biostatistics

Job Number: 22449

Location: Waltham, MA

Job Description

We are seeking an Associate Director to the Biostatistics group. This position will report to the Head of Biometrics and be located in the Waltham, MA office.

Responsibilities

  • Serve as a lead statistician and manage statistical efforts for multiple clinical studies and/or a clinical program
  • Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
  • Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit shells for tables, figures and listings
  • Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
  • Provide statistical input to data monitoring committee (DMC) charters, project management plan, and other study-level documents
  • Work with statistical programmers or CROs to generate tables, figures and listings
  • Perform ad hoc and exploratory statistical analyses as needed
  • Contribute to clinical study reports, including authoring of statistical sections and interpretation of the study results
  • Support regulatory submissions as needed; provide response to regulatory requests independently
  • Support the preparation of publications, including manuscripts, posters and oral presentations
  • Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs
  • May have direct reports

Required Skills

Required Qualifications:

  • PhD in statistics or a related field with at least 6 years of relevant clinical trial experience or MS in statistics or equivalent with at least 8 years of relevant clinical trial experience
  • Knowledge of statistical methods for clinical trials
  • In-depth Knowledge of FDA, EMA and ICH regulations and guidelines
  • Proficient in statistical programming (SAS is required)
  • Experience with trial design software (e.g., EAST or nQuery)
  • Good communication skills and ability to work with cross-functional study teams
  • Good organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Good analytical and problem-solving skills
  • Positive and collaborative attitude

Preferred Qualifications:

  • Experience with NDAs/BLAs, MAAs and other regulatory submissions is a plus
  • Proficient in running simulations using either SAS or R

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care

 

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