Sr Manager, Statistics

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.

In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing syndrome).

Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advance the possibilities of cortisol modulation.

What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.

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.

For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

Please visit our website at: https://www.corcept.com/

Corcept is an Equal Opportunity Employer

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