Sr Manager/Associate Director – Statistics

Sr Manager/Associate Director – Statistics

Requirements

• Knowledge of global regulatory guidance on statistical methods for analyses of clinical data, and global submission requirements
• Proficient with statistical analysis methodologies and experimental design related to endocrinology, oncology and neurology studies
• Strong demonstrated interest in statistical research activities and application of novel methods to clinical trial development
• Knowledge of missing data handling, multiple comparisons, survival analyses techniques and simulation techniques
• Experience in organizing and driving regulatory submissions such as NDA, sNDA, and MAA submissions
• Good working knowledge of ICH, FDA and GCP regulations and guidelines
• Ability to learn, be proactive, motivated, and consistently focused on details and project execution
• Proficiency with statistical programming in SAS (including SAS/STAT, SAS/GRAPH, SAS/MACRO) and R
• Proficiency with sample size calculations software
• Familiarity with CDISC SDTM and ADaM specifications and associated regulatory guidance
• Excellent analytical, oral and written communication and organizational skills
• Demonstrated ability to communicate technical information to internal cross-functional teams and leadership team
• Experience in vendor audits and regulatory inspections

Responsibilities

• Partner with Clinical Development, Regulatory, Pharmacovigilance, Quality Assurance, Commercial organizations on design and execution of clinical trials in Corcept portfolio
• Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS/ISE. Participate in writing regulatory documents (briefing documents, safety summary, efficacy summary)
• Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities
• Partner with Statistical Programming in generation of statistical analyses for internal and external presentations, and validation of statistical analyses results generated in-house or by CROs
• Partner with Statistical Programming in evaluation CDISC electronic data packages for completeness, regulatory standards compliance and submission readiness
• Oversee execution of the statistical components of clinical studies in house and by CROs and independent contractors. Negotiate and ensure on-time and quality delivery of CRO generated analyses results
• Stay current with regulatory requirements for statistical methods of analyses and scientific developments in statistical methods for clinical trials
• Consult internal audit team in assessing regulatory compliance of CROs with respect to statistical SOPs
• Participate in standards governance and development of Corcept Biostatistical SOPs (including work instructions, templates and forms)
• Identify and anticipate technical or other potential problems arising in the design, conduct, and analysis of studies, proposing and implementing solutions
• Ensure consistency and adherence to standards across compounds and/or therapeutic areas

Preferred Qualifications

• PhD in Statistics, Biostatistics, or Mathematics
• 5+ years of experience in clinical trials and pharmaceutical industry
• Demonstrated ability for project management of competing priorities in clinical development
• Experience managing delivery of statistical projects by CROs
• Demonstrated ability to apply complex statistical methods, conduct and interpret the results
• Excellent interpersonal, problem solving, communication and influence/negotiation skills
• Able to navigate uncertainty with creative problem solving
• Ability to take a hands-on, “roll up your sleeves” approach