We are looking for a Senior Biostatistician experienced in supporting clinical trials to join our team!
Are you looking for a rewarding career and opportunity to change people’s lives? Are you interested in discovery and innovation in a growing and supportive environment? Do you have previous clinical trial experience? If so, read on…
As a core member of the Biostatistics & Statistical Programming group, the Senior Biostatistician leads teams and provides sound statistical guidance and consultation on both academic and regulatory directed initiatives.
In this position you will:
- Guide project teams in the selection of optimal study design, data collection and statistical analysis.
- Develop high quality Statistical Analysis Plans including mock display shells for study reporting.
- Provide statistical leadership for the design, writing and review of study protocols, including sample size/power estimations.
- Plan, analyze and prepare reports for interim analyses, DSMBs, manuscripts and abstracts.
- Confidently interact with clients and effectively communicate statistical issues to project team members to influence team decisions.
- Oversee the timing and quality of deliverables and the assessment of resource within project activities.
- Utilize SAS for programming, validation, analysis, and reporting of clinical data (proficiency in additional statistical or programming languages e.g. R, Python is welcome).
- Ensure compliance with GCP, FDA, and ICH guidelines and CPC standards.
- Provide statistical input on clinical electronic data capture (EDC) design, edit checks and trending reports to innovate and increase the quality of data collection.
Here's what you will need to bring to the table:
- Master’s or Ph.D. degree in biostatistics or related field and hands on experience with the application of study designs and analytic methods in clinical trials.
- Minimum of 5 years of experience in the analysis of data for clinical trials with at least 3 years’ experience with Phase 1-4 clinical trials in the pharmaceutical industry.
- Experience in the application of common statistical methods to clinical trials including parametric and non-parametric analysis, linear and non-linear models, categorical data and survival analysis.
- Experience developing Statistical Analysis Plans for clinical trials intended for submission to regulatory agencies.
- Proven ability to contribute to clinical study reports intended for submission to regulatory agencies.
- Prior experience serving as a lead biostatistician on project teams.
- Ability to work independently and commitment to effectively oversee others in the development or validation of statistical programming.
- Demonstrable programming experience with SAS 9.0 or higher in a Windows environment.
- Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook).
- Good knowledge of ICH guidelines, experience with Phase I-III clinical trials and FDA/NDA submissions.
- Impeccable attention to detail and excellent analytical and organizational skills.
Viable applicants will be required to demonstrate their computer skills as well as pass a background and education verification check.
Note this is not a remote position. We prefer someone who is willing to be co-located and engage with clinical and scientific teams on a regular basis.
CPC is an academically led clinical research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 25 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.
CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/
- Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
- Matching 401(k) plan
- 10 paid holidays
- In-suite exercise room
- In-suite relaxation room
- In-office masseuse 3x/month
- Monthly fun events (i.e. sports games, potlucks, picnics)
- Flexible work schedules
Visit our web site to learn more about us and values we embrace: www.cpcmed.org
An Equal Opportunity Employer
CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, sex, gender identity, veteran status, marital status, sexual orientation, age, disability, genetic information or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team.