Company DescriptionJob DescriptionWe are seeking an experienced
Director, Biostatistics to serve as Study Statistician across one or more drug development programs. This individual will provide statistical strategy from early development through regulatory submission, partnering cross-functionally to drive data-informed decision-making and ensure scientific and regulatory excellence.
Key Responsibilities- Provide statistical strategy and oversight for multiple clinical studies or programs across all phases of development
- Contribute to Clinical Development Plans and represent Biostatistics on cross-functional teams
- Design studies, author and review protocols and Statistical Analysis Plans (SAPs), and oversee interim and final analysis
- Ensure quality, accuracy, and reproducibility of statistical outputs in collaboration with programming teams and CROs
- Support regulatory submissions (INDs, NDAs, BLAs, MAAs), including health authority interactions and integrated summaries (ISS/ISE)
- Provide oversight of external vendors and mentor junior statisticians or contractors
- Contribute to publications, conference presentations, and continuous improvement initiatives
QualificationsQualifications- PhD in Statistics (or related field) with 8+ years of clinical trial experience, or MS with 12+ years of experience
- Deep knowledge of statistical methods for clinical trials and FDA, EMA, and ICH guidelines
- Proficiency in SAS or R; experience with trial design software (e.g., EAST, nQuery)
- Strong analytical, problem-solving, communication, and influencing skills
- Ability to manage multiple priorities in a fast-paced environment
Preferred- Experience supporting NDAs, BLAs, MAAs, and regulatory inspections
- Experience conducting simulations using SAS, R, or related software
This is a highly visible role offering the opportunity to shape statistical strategy and directly impact regulatory success and patient outcomes.
Additional InformationDeciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $200,000 - $275,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)
Benefits:- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the 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. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
