Director, Biostatistics

Waltham, MA - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

We 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

Qualifications :

Qualifications

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 Information :

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $200000 - $275000. 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 Decipheras 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 INFORMATION

Deciphera 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.

Remote Work :

Yes

Employment Type :

Full-time

We 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-makin...