Corcept Therapeutics
Sr Manager, Statistics
Corcept Therapeutics, Menlo Park, California, United States, 94029
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 portfolioResponsible 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 activitiesPartner with Statistical Programming in generation of statistical analyses for internal and external presentations, and validation of statistical analyses results generated in-house or by CROsPartner with Statistical Programming in evaluation CDISC electronic data packages for completeness, regulatory standards compliance and submission readinessOversee 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 resultsStay current with regulatory requirements for statistical methods of analyses and scientific developments in statistical methods for clinical trialsConsult internal audit team in assessing regulatory compliance of CROs with respect to statistical SOPsParticipate 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 solutionsEnsure consistency and adherence to standards across compounds and/or therapeutic areasPreferred Skills, Qualifications and Technical Proficiencies:
Knowledge of global regulatory guidance on statistical methods for analyses of clinical data, and global submission requirementsProficient with statistical analysis methodologies and experimental design related to endocrinology, oncology and neurology studiesStrong demonstrated interest in statistical research activities and application of novel methods to clinical trial developmentKnowledge of missing data handling, multiple comparisons, survival analyses techniques and simulation techniquesExperience in organizing and driving regulatory submissions such as NDA, sNDA, and MAA submissionsGood working knowledge of ICH, FDA and GCP regulations and guidelinesAbility to learn, be proactive, motivated, and consistently focused on details and project executionProficiency with statistical programming in SAS (including SAS/STAT, SAS/GRAPH, SAS/MACRO) and RProficiency with sample size calculations softwareFamiliarity with CDISC SDTM and ADaM specifications and associated regulatory guidanceExcellent analytical, oral and written communication and organizational skillsDemonstrated ability to communicate technical information to internal cross-functional teams and leadership teamExperience in vendor audits and regulatory inspectionsPreferred Education and Experience:
PhD in Statistics, Biostatistics, or Mathematics5+ years of experience in clinical trials and pharmaceutical industryDemonstrated ability for project management of competing priorities in clinical developmentExperience managing delivery of statistical projects by CROsDemonstrated ability to apply complex statistical methods, conduct and interpret the resultsExcellent interpersonal, problem solving, communication and influence/negotiation skillsAble to navigate uncertainty with creative problem solvingAbility 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
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.
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 portfolioResponsible 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 activitiesPartner with Statistical Programming in generation of statistical analyses for internal and external presentations, and validation of statistical analyses results generated in-house or by CROsPartner with Statistical Programming in evaluation CDISC electronic data packages for completeness, regulatory standards compliance and submission readinessOversee 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 resultsStay current with regulatory requirements for statistical methods of analyses and scientific developments in statistical methods for clinical trialsConsult internal audit team in assessing regulatory compliance of CROs with respect to statistical SOPsParticipate 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 solutionsEnsure consistency and adherence to standards across compounds and/or therapeutic areasPreferred Skills, Qualifications and Technical Proficiencies:
Knowledge of global regulatory guidance on statistical methods for analyses of clinical data, and global submission requirementsProficient with statistical analysis methodologies and experimental design related to endocrinology, oncology and neurology studiesStrong demonstrated interest in statistical research activities and application of novel methods to clinical trial developmentKnowledge of missing data handling, multiple comparisons, survival analyses techniques and simulation techniquesExperience in organizing and driving regulatory submissions such as NDA, sNDA, and MAA submissionsGood working knowledge of ICH, FDA and GCP regulations and guidelinesAbility to learn, be proactive, motivated, and consistently focused on details and project executionProficiency with statistical programming in SAS (including SAS/STAT, SAS/GRAPH, SAS/MACRO) and RProficiency with sample size calculations softwareFamiliarity with CDISC SDTM and ADaM specifications and associated regulatory guidanceExcellent analytical, oral and written communication and organizational skillsDemonstrated ability to communicate technical information to internal cross-functional teams and leadership teamExperience in vendor audits and regulatory inspectionsPreferred Education and Experience:
PhD in Statistics, Biostatistics, or Mathematics5+ years of experience in clinical trials and pharmaceutical industryDemonstrated ability for project management of competing priorities in clinical developmentExperience managing delivery of statistical projects by CROsDemonstrated ability to apply complex statistical methods, conduct and interpret the resultsExcellent interpersonal, problem solving, communication and influence/negotiation skillsAble to navigate uncertainty with creative problem solvingAbility 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
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.