Director, Biostatistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee product and indication level responsibilities, including regulatory communications and submissions, while ensuring statistical validity; strategically support related projects from a statistical standpoint.

• Contribute to study-specific tasks from a statistical viewpoint, such as study design and determining sample sizes; author or review the statistical sections of the protocol, SAP, and DMC charter; create and review study randomization files; develop TFL shells and specifications; review CRFs and other study documents; actively participate in study-related meetings.

• Collaborate effectively within biometrics teams and across different functions to achieve product objectives and timelines for statistical data analysis and reporting.

• Maintain the statistical integrity of deliverables; provide sound scientific methodology to fulfill project goals and comply with regulatory statistical and data standards.

• Independently perform analyses based on data; propose innovative statistical methodologies to enhance the efficiency and sensitivity of study outcomes.

• Assist in establishing standards and conducting research in advanced statistical methodologies.

• Author or review regulatory documents and scientific publications.

• Provide mentorship to junior team members.

⛳️ Requirements

• PhD in Statistics or Biostatistics with a minimum of 8 years of post-graduate experience in clinical trials within the pharmaceutical sector (minimum of 11 years for those with a Master’s degree).

• Proven experience in NDA, BLA, and MAA activities as a key statistical contributor, with direct involvement in regulatory interactions.

• Experienced as the lead statistician on products, contributing to strategic discussions in cross-functional environments; adept at managing multiple products and studies while prioritizing effectively.

• Familiarity with study-level tasks, including the authorship of SAP and TFL specifications.

• Knowledgeable in ICH guidelines and guidance from FDA, EMA, and other regulatory bodies.

• Strong understanding of mathematical and statistical principles; prior experience with statistical methods for analyzing longitudinal data is preferred.

• Detail-oriented with strong organizational, problem-solving, and prioritization skills; demonstrated capability to manage and complete multiple tasks within company timelines.

• Proficient in SAS and R, with a preference for knowledge of CDISC standards, including SDTM, ADaM, and controlled terminologies.

🏝️ Benefits

• Generous vacation time and public holidays observed by the company.

• Volunteer days.

• Long-term incentives and employee stock purchase plans or equivalent offerings.

• Employee wellbeing benefits.

• Fitness reimbursement.

• Tuition sponsorship.

• Professional development plans.