<p>We are seeking a Principal Biostatistician to join our team. The Principal Biostatistician will be a key member of a highly collaborative Clinical Development team. This is a hands-on role.</p> <p>This position reports to the Executive Director, Biostatistics and Programming and will be based out of Boston, MA, USA in our Needham office. We will consider other jurisdictions for exceptional candidates. For Boston based candidates, this role is a hybrid position, requiring a minimum of 2 days per week in the office.</p> <p>RESPONSIBILITIES:</p> <ul> <li>Provide statistical leadership for assigned clinical development programs or trials. </li><li>Participate in the development of study protocols, write the statistical section of study protocols, develop statistical analysis plans and analysis specifications for the programming implementation of statistical analyses. </li><li>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. </li><li>Develop statistical programs, as needed, in support of ad-hoc requests, manuscripts and presentations and provide statistical review of scientific reports and publications. </li><li>Collaborate and write statistical sections of regulatory documents. </li><li>Collaborate with other functional areas on project deliverables and timelines within area of responsibility. </li><li>Provide oversight of CRO deliverables within area of responsibility to ensure quality and accuracy. </li><li>Adhere to the company and department SOPs and working practices. </li><li>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. </li></ul> <p>QUALIFICATIONS:</p> <ul> <li>A Principal Biostatistician will have a PH.D. in Statistics or Biostatistics with a minimum of 4 years of statistical experience in the pharmaceutical or biotech industry, or Master with a minimum of 6 years of experience. </li><li>Up-to-date knowledge of statistical methodologies related to areas such as clinical trial design, statistical modeling and analysis. </li><li>Knowledge of applicable FDA regulations and ICH guidelines. </li><li>Advanced knowledge of the SAS programming language; knowledge of R or similar language a plus. </li><li>Knowledge of CDISC standards, including ADaM requirements. </li><li>Experience in CNS preferred. </li><li>Experience in CRO management. </li><li>Experience in NDA/MAA submission a plus. </li><li>Strong organizational and time management skills, and the ability to prioritize multiple deliverables and ad-hoc requests. </li><li>Strong communication skills, both oral and written. </li><li>Strong interpersonal skills, ability to build credibility and trust inside and outside the Company. </li><li>Ability to travel up to 10%, both domestically and internationally. </li></ul> <p>The base salary range for this role is $126,700 to $160,200 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.</p>