Associate Director of Biostatistics

Waltham, MA
Clinical Development & Operations – Clinical Development
Full Time
Company Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off” or inactivated conformation. These investigational therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their responses to treatment.

We offer an outstanding culture and opportunity for personal and professional growth based on these key principles:
·       providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
·       a diverse and multi-disciplinary workforce
·       dedicated and talented people who are passionate about achieving excellence in all they do
·       a work environment that allows you to balance your priorities
·       above all else, a commitment to the patients we serve

We are seeking an Associate Director to the Biostatistics group.

This position will report to the Senior Director, Biostatistics and Data Management and be located in the Waltham, MA office.  

Key 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 director reports

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
In providing information about work experience in the application process, a candidate may include any verified work performed on a volunteer basis.  In addition, the following is for the information of applicants for employment in Massachusetts:  It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.  An employer who violates this law shall be subject to criminal penalties and civil liability.