Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK® is Deciphera’s FDA-approved switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also approved for fourth-line GIST in Australia, Canada, China, and Hong Kong.

Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas.

We offer an outstanding culture and opportunity for personal and professional growth based on our “PATHS” Core Values:

Patients – places the importance of improving the lives of patients and their caregivers at the forefront of every day’s work.

Accountability – for our performance and the way we work with coworkers and other stakeholders.

Transparency – in our intent and actions to both internal and external stakeholders.

Honesty and Integrity – fosters trust and strives to deliver on our and the company’s promises.

Stewardship – values and uses wisely the resources and investments provided to the company.

An exciting opportunity to join a fast-paced oncology-focused biopharmaceutical company making a difference for patients globally. You will join a group of highly motivated, top-notch biostatistics and clinical development professionals and will be a key player in shaping the biostatistical strategy for key clinical studies. The role offers exciting opportunities for learning and growth as you partner cross-functionally to develop statistical analysis plans and contribute to the overall clinical development strategy.

The Role:

We are seeking an Associate Director of Biostatistics to join our team. In this role, the successful candidate will serve as the lead study statistician on one or more studies, which may include pivotal studies. The successful candidate will also lead regulatory submission related tasks and represent Deciphera in communications with regulatory authorities.

What You’ll Do:

• Serve as a lead statistician and manage statistical efforts for multiple clinical studies
• Represent the biometrics functions on cross-functional teams and make strategic contributions to the clinical development plan (CDP)
• Serve as the biostatistical lead in regulatory submissions and inspections
• Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
• Author/review statistical analysis plans for studies, 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 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 manage FTE/contractor direct report(s) as needed
• #LI-PH1

• 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
• Experience with NDAs/BLAs, MAAs and other regulatory submissions
• Proficient in statistical programming (SAS or R 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 influencing skills to ensure good statistical and quantitative expertise is adopted in clinical development
• 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

What Deciphera will Bring:

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes the following:

• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• An annual lifestyle allowance
• Internal rewards and recognition program

Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.