Study Lead Statistician needed for a one year W2 contract for a global pharmaceutical company in Thousand Oaks, CA.
This is a remote role and will consider candidates in PST zone.
Hourly Rate: $90.00-$98.00
The Study Lead Statistician (SLS) oversees statistical aspects of clinical studies for product development. They ensure study planning, statistical power, Regulatory compliance, and maintain study integrity. Collaborating with cross-functional teams and the Global Statistical Lead, the SLS aligns studies with product strategy. They also support Regulatory activities and publications, while ensuring study quality. **
What can you bring to this role:**
- Masters degree in Statistics or Biostatistics. Must have 4-6 years of post graduate statistical experience in the pharmaceutical industry or medical research
- Doctoral degree in Statistics or Biostatistics. Must have 3-5 years of post graduate statistical experience in the pharmaceutical industry or medical research
- Experience SAS software
- Must have clinical trial experience with drug development, preferred Life Cycle Drug Development
- Designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
- Demonstrated ability in presenting results and defending statistical findings, study design and analysis to internal audiences (study/product team) AND at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings
- Leadership of at least 3 clinical studies/projects end-to-end with minimal oversight
- Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions, working with clinical development colleagues in study management, programming and IS
- Experience in adaptive clinical trials and innovative study designs
- Experience in the utilization of Bayesian statistics in clinical trials
- Proficient R programming skills conducting simulations and applying statistical concepts and methods based on complex study designs
What the day to day looks like:
- Provide statistical guidance, review, and contribution to protocols, SAPs; TFL shells; DMC Charters; SDF specifications (SDTM and ADaM); randomization specifications; other key-study related documentation, protocol deviations, data quality review, and other communications? Attend and be a contributor at Clinical Study Team Meetings
- Attend meetings for and provide statistical input into cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review? Initiate cross-functional team meetings as necessary (e.g., SAP review, TFL shell review, TFL review)
- Provide statistical guidance, review, and be responsible for statistical analysis of individual studies/projects
- Perform and document QC of primary and key secondary endpoints within ADaM datasets as well as the statistical analyses of these endpoints (programmatically)
- Perform data-driven modeling during clinical studies
- Coordinate the creation of required outputs for Dose Level Review Meetings (DLRMs) as well as coordinate and participate in the DLRM
- Review TFLs created by statistical programming for consistency and accuracy
- Author analysis reports such as Flash Memo, and results section of the CSRs
- Collaborate with the study programming team for study deliverables
- Manage timelines for all statistics-related deliverables by working with the cross-functional team members (e.g., programmers, study statisticians, clinical data managers, medical writers)
- Assist with study and systems audits conducted by Company GCA and external bodies
What’s In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.
Medical, Dental & Vision Benefits
401K Retirement Saving Plan
Life & Disability Insurance
Direct Deposit & weekly ePayroll
Employee Discount Programs
Referral Bonus Programs
Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
