Reporting to the SVP, Clinical Development, this role will provide strategic and operational biostatistical leadership for the clinical development programs and the associated clinical trials. This includes but is not limited to: defining data analysis methodologies, implementing these methodologies, interpreting the resulting findings and crafting and communicating key messages to internal audiences and selected key external stakeholders. This role will interact with regulatory agencies on matters related to the data for clinical programs and trials. This position works cross-functionally with internal departments and external resources on biostatistics related issues and is accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. This role will influence the internal and external environment as a key contributor to strategic long-term decision-making in clinical development.
II. Principal Duties and Responsibilities include the following:
• Provides guidance and direction on the statistical elements of clinical development strategy across programs
• Ensures that statistical strategy, analyses and associated statistical programming activities support product and clinical development strategy; ensures statistical consistency across company, compliance with relevant regulatory requirements and delivery in a timely manner according to project plan
• Leads and contributes to the production of all trial-related and ad hoc statistical analyses, including the statistical programming; interprets data and provides statistical input to clinical study team(s) regarding clinical trial results, Clinical Study Reports (CSR) - including tables, listings and graphs - and regulatory submissions; contributes to publications activities, scientific presentations and promotional material
• Provides leadership for, and may contribute directly to, the statistical strategies including the development of Statistical Analysis Plans
• Provides strategic guidance/direction and as required, contributes to the assessment, recommendation and implementation of the statistical data analysis methodologies that align with clinical study objectives and endpoints
• Evaluates deliverables generated by consultants/ Contract Research Organizations (CROs) for validity, quality, and effectiveness of presentation
• Represents biostatistics in interactions with the clinical, regulatory, and commercial teams to communicate and resolve statistical issues; represents biostatistics in vendor qualification, selection, and management of data management technical tasks assigned to CROs
• Interacts with global regulatory and health authorities and acts as a Subject Matter Expert for the biostatistics function, the statistical analysis and programming methods employed in clinical data analysis.
• Perform other duties when requested.
III. Supervisory Responsibilities:
IV. Qualification Requirements:
• MS (PhD is preferred) in Statistics or equivalent with at least 7 years of progressively responsible statistical experience in a pharmaceutical, biotechnology, or related environment
• Hands-on experience setting strategic direction and providing tactical input for the statistical elements of clinical development
• Demonstrated, broad, hands-on experience with clinical data analysis and reporting including thorough knowledge/expertise of the theory and techniques of the applied statistical methods commonly used within the pharmaceutical industry.
• Experience providing and reviewing content for NDAs, INDs and other regulatory filings
• Experience representing the statistical aspects of clinical development programs and products with key external stakeholders including regulatory agencies, collaborators/business partners, KOLs, etc
• Ability to influence without direct authority
• Excellent verbal and written communication and skills
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members
• Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projectsAbility to think proactively, strategically and creatively
• Strong interpersonal skills with ability to work in a team environment as well as independently
• Ability to assimilate new information rapidly, multi-task, and work across multiple projects