As a
pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a
better tomorrow. We
take pride in improving patient outcomes and advancing
healthcare. At
UBC, we provide services to enhance the entire drug development process and
commercialization lifecycle - From clinical trial support to real-world
evidence generation.
Embark on a
rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our
Core Values of Respect, Accountability, Innovation, Quality, Integrity, and
Collaboration. We believe in an inclusive workplace that fosters creativity.
If you are
seeking a career that will challenge, inspire, and reward you, join us at UBC!
Job Title: YCI01J - Senior Principal Statistician
Brief Description:
Provide strategic input, statistical expertise and leadership to project teams in the design and analysis of clinical trials or observational studies, act as lead statistician, provide support for validation of tables, listings and figures, provide expert advice on at least one subfield of statistics and lead department initiatives. Preferred experience in with statistical methodologies employed in non-interventional studies.
Specific Job Duties:
- Participate, without supervision, in protocol development or clinical development plan process, including discussions of study designs, selection of endpoints, sample size determination, and preparation of statistical section of the protocol supporting Phase I-IV Clinical Trials, REMS, Registry, Survey, Chart Review, or other post marketing studies
- Act as advisor in the conduct and analysis of clinical studies
- Prepare statistical analysis plans and be able to present and support them with clients or regulatory agencies
- Apply complex statistical methods and analyze clinical study data or observational study data
- Provide statistical programming and validation support
- Prepare statistical section of clinical trial reports or other statistical documents in support of an NDA or MAA
- Prepare materials/presentations to support clients in regulatory related meetings at the different stages of development (IND, end-of-phase II, pre-NDA, NDA review)
- Participate in proposal preparation as primary author for statistical sections, resource allocation and proactively manage timelines for Biometrics deliverables development
- Act as Project Leader in Biometrics Project Team (Data Management, Programming, Statistics)
- Train and mentor junior statistical personnel
- Develop and maintain statistical SOPs
Supervisory Responsibility: N/A
Desired Skills and Qualifications:
- 8 or more years of statistical experience or relevant experience in the pharmaceutical/CRO industry
- Ph.D. in statistics/biostatistics with 6 years of experience (at least 4 years of clinical trials experience), or M.S. degree with at least 8 years of experience in the pharmaceutical industry
- Experience with application of a variety of statistical methods and ability to work on complex statistical problems
- Solid knowledge of SAS and familiarity with other statistical software packages
- Ability to clearly and effectively communicate and interact with clients
- Strong analytical, problem-solving, excellent written and oral communication and organizational skills
- Ability to work both independently and as a part of a project team
- Exposure and familiarity with relevant ICH and FDA guidelines
- Ability to search and review relevant medical literature
- Project management experience
Benefits:
At UBC, employee growth and well-being are always at the
forefront. We offer an extensive range of benefits to ensure that you have
everything you need to thrive personally and professionally.
Here
are some of the exciting perks UBC offers:
- Remote opportunities
- Competitive salaries
- Growth opportunities
for promotion
- 401K with company
match*
- Tuition
reimbursement
- Flexible work
environment
- Discretionary PTO
(Paid Time Off)
- Paid Holidays
- Employee assistance
programs
- Medical, Dental, and
vision coverage
- HSA/FSA
- Telemedicine
(Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term
disability
- Long term disability
- Life insurance
- Discount
programs
UBC is proud to be an equal opportunity employer and
does not discriminate because of race, color, sex, age, national origin,
religion, sexual orientation, gender identity and/or expression, status as a
veteran, and basis of disability or any other federal, state, or local
protected class. We are committed to a diverse, equitable and inclusive culture
that fosters respect for each other, our clients, and our patients.
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