Hello,
Theorem is seeking a Director of Statistics for a remote, home-based position in California for our West Coast Clients. Please apply directly using the link below or feel free to email me with your resume and/or any inquiries.
Kelly Spak
Sourcing Specialist/Recruiter
P: (484) 682-8336
E: Kelly.Spak@theoremclinical.com
View Kelly Spak's LinkedIn Profile
DIRECTOR, STATISTICS
When you're ready to join a company that's as dedicated to excellence as you are, THINK THEOREM. We have an opening for a Director of Statistics for a permanent, salaried role on the West Coast of the US. In this role, the selected candidate will lead projects and groups of Biometrics personnel within one geographic location. The selected candidate will be responsible for managing, possess the capability to analyze all parts of any clinical study, and also provide planning on multiple clinical studies from multiple clients. Additionally, you will work extensively with Biometrics project team members and effectively communicate with other departments and project teams involved in the clinical trials along with the following:
- Able to coordinate an IDMC and be statistician as part of the statistical coordinating center for a IDMC and write a charter for independent data monitoring committee (IDMC).
- Supervise statisticians up to Senior Project Statistician level and manage Biometrics project teams and track department project activities (including project revenue) and provide status updates. Additionally, the selected candidate will coach and develop staff members for professional enhancement and perform Employee Performance Appraisal for these direct reports.
- Assist in the administration of the department processes including resource and project scheduling, interviewing and hiring, training of staff, establishing departmental processes, and interaction with other departments. Review and approve work of other members in the department so that a quality product is provided to the client.
- Prepare detailed statistical analysis plans for a single project and for an integrated summary of safety (ISS) and an integrated summary of efficacy and review and approve case report form (CRF) design, data management plan, and edit specifications for a clinical trial.
- Able to present at bid defenses for Biometrics; represent department on interdepartmental project teams; may serve as a back−up to represent clients at FDA meetings; and serve as project leader for "back−end" projects involving multiple studies and may serve as primary statistical contact with clients for projects of diversified scope.
- Able to properly review CSRs to ensure appropriate representation of statistical methodology and inference.
- Respond to sponsor audit and ability to write standard operating procedures (SOPs).
- May be responsible for statistical activities associated with clinical research studies and with programs leading to regulatory submissions.
- Perform quality control of datasets and data displays for integrated summary of efficacy (ISE); supervise quality control of datasets and data displays for ISS and ISE.
- Prepare statistical sections of protocols, including sample size calculations; develop randomization specifications and verify randomization codes for basic and complex clinical trials; prepare and annotate safety and basic and complex efficacy shell data displays
- Able to conduct all statistical analyses in support of clinical research studies.
- Provide specifications for structure, content and algorithms for safety and efficacy analysis datasets.
- Perform quality control of complex efficacy analysis datasets and supervise quality control of safety and all efficacy analysis datasets.
- Perform validation and quality control of complex efficacy data displays and supervise validation and quality control of safety and all efficacy data displays that show inferential statistics.
- Write statistical reports and statistical section of the clinical study report (CSR).
We require a Master's degree/Ph.D. in Statistics/Biostatistics or equivalent; 6 years for M.S. and 5 years for Ph.D. with clinical data experience. High degree of accuracy and attention to detail along with Proficiency in SAS and ability to program using SAS macro language. Proficiency in statistical procedures including non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques are also required along with excellent project management and organizational skills. Additionally, the selected candidate will have previous responsibility for a large portion of the statistical content of at lease on NDA submission, the understanding of data management flow in clinical trial environment and extended knowledge of procedures of clinical programming. No special physical demands and major part of work done in office environment. Some travel required for project team meetings.
To apply, please visit:
http://tinyurl.com/ng78j94
For more information about our Biometrics group, please visit: http://www.theoremclinical.com/biometrics.aspx
For more information about Theorem Clinical Research, please visit:
http://www.theoremclinical.com/
At Theorem, you'll join a team of like-minded individuals headed by some of the most dynamic and influential leaders in drug and medical device development today. You'll work on cutting-edge global research projects in a fast-paced but collegial atmosphere where you'll have the opportunity to make meaningful - and acknowledged - contributions. You'll have opportunities to grow personally and professionally and abundant room for advancement along with generous incentive programs.
Theorem Clinical Research Inc. is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world's top pharmaceutical, biotech and medical device companies. As a forerunner in medical device and drug-device combination trials with notable capabilities in pharmaceuticals and biologics, Theorem offers deep expertise in a broad range of therapeutic areas and in all phases of development. With some of the industry's top scientists and most advanced clinical analytics capabilities, Theorem ensures smooth-running, successful trials. For the full-service, right-size global research partner, don't think twice. THINK THEOREM.
Theorem Clinical Research is an equal opportunity employer, M/F/D/V