Associate Director, Biostatistics

We are seeking an Associate Director, Biostatistics to join our team. The incumbent will be a key member of a highly collaborative Clinical Development team. This is a hands-on role that may have direct reports in the future. Associate Director level candidates will have proven leadership ability in a fast paced, multi-location environment and interact with all levels of internal staff as well as external stakeholders, including, but not limited to CROs.

This position reports to the Executive Director, Biostatistics and Programming, and will be located in the Boston, MA, USA location: we may consider other US locations for an exceptional candidate.

RESPONSIBILITIES:

• Serve as the lead statistician, develop or supervise the development of the statistical sections of protocols, statistical analysis plans and analysis specifications for the programming implementation of the statistical analyses.
• Collaborate with Clinical Science to develop innovative trial designs that are aligned with the project strategy and that address statistical, medical, and/or operational issues.
• Provide statistical input into data management and programming deliverables (e.g., data collection tools, analysis datasets) to ensure that they support the protocol specified goals and statistical analyses.
• Develop statistical programs, as needed, in support of ad-hoc requests, manuscripts and presentations and provide statistical review of scientific reports and publications.
• Collaborate with other functional areas on project deliverables and timelines within area of responsibility.
• Manage CROs within area of responsibility ensuring the quality, accuracy, and timeliness of outsourced statistical deliverables.
• Adhere to the company SOPs and working practices; help develop SOPs relevant to the biostatistical function.
• Provide timely feedback to manager regarding statistical deliverables.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
• Input in planning and managing budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
• Recruit, lead, direct, develop, coach, and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Other duties as assigned.

QUALIFICATIONS:

• An Associate Director will have a Ph.D. in Statistics or Biostatistics with 6+ years of experience in the pharmaceutical or biotech industry, or master’s with 8+ years of experience; previous management experience preferred.
• Up-to-date expertise/knowledge in advanced statistical methodologies related to clinical trial design, statistical modeling, and analysis.
• Experience with multiple phases of clinical development and regulatory submissions
• Knowledge of applicable ICH and FDA regulations.
• Proficiency with the SAS programming language; knowledge of R or similar language a plus.
• Knowledge of CDISC standards, including ADaM requirements.
• Experience in CNS preferred.
• Experience in CRO management.
• Experience in NDA/MAA submission preferred
• Strong leadership and interpersonal skills, ability to build credibility and trust inside and outside the Company.
• Strong organizational and time management skills, and the ability to prioritize multiple deliverables and ad-hoc requests.
• Be science and data driven while at the same time, be creative and flexible in strategic thinking and problem solving.
• Ability to travel up to 10%, both domestically and internationally.

The base salary range for this role is $183,900 to $232,500 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.