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    Sr Manager, Statistics - Menlo Park, United States - Corcept Therapeutics

    Corcept Therapeutics
    Corcept Therapeutics Menlo Park, United States

    2 weeks ago

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    Description

    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.

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