General Description:

Supporting clinical development with a focus in hematologic diseases, the position will work with the clinical and regulatory team in designing clinical trials, develop statistical analysis plans, facilitate the implementation of statistical analyses, provide statistical inputs to the CSR and scientific presentations/manuscripts, perform statistical functions for submission related activities, as well as submission activities. The position will participate in process improvement, training, SOP development, and mentoring junior statisticians as a senior member of biostatistics department.

This individual will interface with clinical therapeutic area members, statistical programmers, clinical data management, clinical operation, clinical pharmacology, medical writing and other functions. This position will also participate in managing vendors to ensure quality of all deliverables' and adherence to requirements/timeline.

Essential Duties & Responsibilities:

• Knowledge of SAS and/or R is strongly desirable.

• Experience with clinical trials and knowledge of regulatory guidance are required.

• Oncology experience is preferred but not required.

• Demonstrated written and oral communication skills.

• Ability to work within a team and work independently.

• Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision-making capability.

Supervisory Responsibilities:

• None

Computer Skills:

• Knowledge of SAS and/or R is strongly desirable.

Qualifications:

• PhD in Statistics or related field with 2+ years of experience in clinical drug development is required.

• Experiences with clinical trials and knowledge of regulatory guidance are required. Oncology experience is preferred but not required.

• Demonstrated written and oral communication skills and ability to work within a team and work independently are required.

• Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision-making capability.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.