Senior Manager, Biostatistics
At a glance
Senior Data Science role at Corcept Therapeutics. Redwood City · $165,150–$242,820 base.
dataroles summary, based on the employer's posting.
What you'll do
- Coordinate trial design and delivery with clinical, regulatory, manufacturing and commercial teams
- Direct CRO and contractor work on study statistics, keeping analyses accurate and on schedule
- Work with statistical programmers on analyses for presentations and check CRO results for validity
- Review CDISC data packages for completeness, regulatory alignment and readiness for submission
- Help audit CRO statistical practices and shape the team's statistical procedures
What you bring
- A master's or doctorate in statistics, biostatistics, mathematics or a related listed field
- At least two years working on clinical trial development
- Experience overseeing CRO statistical projects and managing their delivery
- Working knowledge of SAS and the ability to apply and interpret complex statistical methods
Who this fits
This role suits a biostatistician who can lead statistical work across clinical development studies and manage outside statisticians and programmers. It is based in Redwood City and typically requires on-site work at least three days each week. You must already be authorized to work full-time in the United States.
From the employer
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.
Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.
Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.
The Senior Manager, Biostatistics will be responsible for leading the execution of statistical components of Corcept Development programs. This position will manage external statisticians and statistical programmers.
This is a hybrid role typically requiring on-site presence at least 3 days per week.
Responsibilities:
- Partner with Clinical Development, Regulatory, Manufacturing, and Commercial organizations on the design and execution of clinical trials in the Corcept portfolio
- Oversee execution of the statistical components of clinical studies by CROs and independent contractors. Manage on-time and quality delivery of CRO-generated analyses results
- Partner with Statistical Programming in generation of statistical analyses for internal and external presentations, and validation statistical analyses results generated by CROs
- Partner with Statistical Programming in the evaluation of CDISC electronic data packages for completeness, regulatory standards compliance, and submission readiness
- 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
Preferred Skills, Qualifications, and Technical Proficiencies:
- Knowledge of global regulatory guidance on statistical methods for analyses of clinical data, and global submission requirements
- Proficiency with statistical programming in SAS. Familiarity with SAS/GRAPH, SAS/MACRO, and R
- Demonstrated ability to apply complex statistical methods, conduct and interpret the results
Preferred Education and Experience:
- MS or Ph.D. in Statistics, Biostatistics, or Mathematics
- 2+ years of experience in clinical trial development
- Demonstrated ability for project management of projects in clinical development
- Experience managing delivery of statistical projects by CROs
The pay range that the Company reasonably expects to pay for this headquarters-based position is $165,150 – $242,820; 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.
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