Associate Director, Biostatistics (Biosimilars)

Key Skills

Biostatistics, Effective communication skills, Statistical modeling

Job Description

• The Associate Director of Biostatistics is responsible for providing the statistical expertise, strategy and managing the activities for one or more clinical development programs (CDPs), either at an early or late development phase, to ensure valid and efficient study designs that allow clearly interpretable results, and timely delivery of analyses, reports and regulatory documents with high quality.
• He/she builds and maintains strong collaboration with key stakeholders from different disciplines across the organization to develop agile and robust clinical development plans and decision framework.
• He/She provides strategic direction and responses to statistical issues arising in regulatory, other legal settings, or external development partners.
• He/She provides direct supervision and mentorship and takes accountability for one or more biostatisticians including assignments, priority setting, and strategic directions and ensures the adherence of standard processes. 
• He/She also contributes to the long-term growth strategy of the department by participating in process improvement initiatives and keeping up to date of and contributes to the current statistical methodology development.

Principal accountabilities

• Key player in the strategic planning and execution of the clinical development plan for the assigned project; provides strategic contributions to the clinical studies in the program, including study designs, protocol development, statistical analysis plans, data analysis and reporting, as well as key contributions to the planning and delivery of clinical components of regulatory submissions including INDs, BLAs, and MAAs.
• Manages assigned internal team members, including more junior statisticians, and external partnerships to ensure quality and consistency of the deliverables; provides guidance and support to facilitate internal team member development and enhanced efficiency; provides regular feedback to staff and management. 
• Provides key strategic contributions in addressing and statistical issues from regulatory, legal or other challenges to the company's products or processes and represents the biostatistics of the company in key regulatory meetings or meetings with KOLs as required.
• Serves as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel (protocols, CSRs, regulatory documents, and manuscripts), and acts as an internal consultant as assigned on broad statistical issues that impact on the pharmaceutical/Biotechnology industry
• Participates in approved process improvement initiatives; keeps up to date on current statistical methodology development and regulatory environment

Qualifications

Minimum education & experience requirements

• PhD in Biostatistics/Statistics or equivalent with a minimum of 6-7 years relevant work experience or MS in Biostatistics/Statistics with a minimum of 8-9 years relevant experience
• Substantial past regulatory interactions.
• Very good understanding of theoretical and applied statistics (including but not limited to Estimands, missing data and (bio)-equivalence trials).
• Ability to develop innovative/creative statistical/technical solutions to complex problems.
• Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies.
• Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas.
• Strong verbal and written communication skills.
• Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflicts resolutions, and effective partnership.