As a member of ONO Group

Director, Biostatistics

DirectorDirectorFull TimeRemoteTeam 201-500Since 2016H1B SponsorCompany Site LinkedIn

Location

Massachusetts

Posted

16 days ago

Salary

$200K - $275K / year

Postgraduate Degree8 yrs expEnglish

Job Description

• 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.

Job Requirements

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.

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.