Director Biostatistics

Responsible for leading the execution of statistical components of Corcept Development programs. This position will manage internal statisticians, as well as external statisticians (private cloud, hybrid cloud and SaaS).

Essential 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 Skills, Qualifications and Technical Proficiencies:

• 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

Preferred Education and Experience:

• PhD in Statistics, Biostatistics, or Mathematics
• 15+ 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

 ** Onsite preferred

The pay range that the Company reasonably expects to pay for this position is $234,100 - $275,400; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education.  An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of financial, health and wellness benefits, dependent on the position offered. 

Applicants must be currently authorized to work in the United States on a full-time basis.

If you are based in California, we encourage you to read this important information for California residents linked here.