Senior Manager/Associate Director, Biostatistics

Supporting clinical development with a focus in hematologic diseases, the position will work with the clinical and regulatory team in designing clinical trials and developing the statistical analysis plan, facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/manuscripts, perform statistical functions for submission related 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, SAS programming, 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.Since we are growing our team, we are open to considering candidates who are either senior or junior to the senior manager level for this opening.Essential Duties & Responsibilities:

A minimum of a master’s degree with 4+ years of experience or a PhD in Statistics or related field with 2+ years of experience in clinical drug development is required.

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.

Education Required:

A minimum of a master’s degree with 4+ years of experience or a PhD in Statistics or related field with 2+ years of experience in clinical drug development is required.

Other Qualifications:

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.

Competencies:Ethics - Treats people with respect; inspires the trust of others; works with integrity and ethically; upholds organizational values.Communication - Listens and gets clarification; responds well to questions; speaks clearly and persuasively in positive or negative situations; writes clearly and informatively; able to read and interpret written information.Teamwork - Balances team and individual responsibilities; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; supports everyone's efforts to succeed; contributes to building a positive team spirit; shares expertise with others.Adaptability – Able to adapt to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events.Technical Skills - Assesses own strengths and opportunities for development; pursues training and opportunities for growth; strives to continuously build knowledge and skills; shares expertise with others.Dependability - Follows instructions and responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan.Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.Analytical - Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data.Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully.Project Management - Communicates changes and progress; completes projects on time and budget.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.