The Sr Manager, Statistics will be responsible for leading the execution of statistical components of Corcept clinical studies.
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
- 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
The pay range that the Company reasonably expects to pay for this headquarters-based position is $193,770 - $227,970; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.