We are looking for a Biostatistician II experienced in supporting clinical trials to join our team!
Remote candidates are welcome to apply.
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 Biostatistician II provides sound statistical guidance and consultation on both academic and regulatory directed initiatives.
In this position you will:
- Act as lead biostatistician for specific study tasks.
- Provide input to study design and statistical analysis details for assigned study and tasks, and communicate with project team members (project manager, data managers, physicians, other biostatisticians).
- Deliver regular feedback to supervising biostatistician or the Head of Biostatistics and project team on project progress, timelines and deliverables, as well as challenges and accomplishments.
- Provide statistical input on clinical electronic data capture (EDC) design as well as assist data management with defining internal and external edit checks to ensure data are collected in a manner which will satisfy any interim and/or final study analyses.
- Ensure the appropriate and accurate application of statistical methods to study design and analysis.
- Provide statistical input to the design, writing and review of study protocols and the development and review of statistical analysis plans (SAP). May lead the development of reporting plans for specific study tasks.
- Utilize SAS for programming, validation, analysis, and reporting of clinical data. May validate programming generated in other statistical packages.
- Develop or validate statistical programs to analyze data in SAS or prepare specifications for a programmer to develop or validate statistical programs to analyze data in SAS.
- Lead reporting efforts and effectively collaborate with others in the development or validation of statistical programming and reporting of results.
- Prepare, review, and submit interim or final reports of clinical data according to study goals.
- Adhere to CPC standards and the goals and requirements of each study or task.
- Lead the planning, analysis, and presentation of non-study specific requests such as manuscripts, abstracts, ad hoc sponsor requests.
- Provide statistical support and consulting to other functions within CPC (e.g. input to data collection or programming support to operational teams).
- Participate in the development and review of statistical standard operating procedures (SOPs).
- Ensure that study protocols, statistical programs, analyses and reports generated within the CPC comply with GCP, FDA, and ICH guidelines and CPC standards.
- May participate in the field of biostatistics/clinical trials through membership in related professional organizations, attending and/or making presentations at professional conferences, and/or submissions to relevant journals.
- Work collaboratively within the biostatistics and programming department and with other departments at CPC to optimize cross department functionality.
- Provide high-quality cost-effective service to industry clients that meets or exceeds industry standards, meets FDA, EMEA and other regulatory requirements, and that aligns well with guidance documents.
- Communicate statistical issues related to study goals to project team members.
Here’s what you will need to bring to the table:
- Master’s or Ph.D. degree in biostatistics or related field, with a minimum of 3 years experience in the analysis of data for clinical trials.
- Demonstrable programming experience with SAS 9.0 or higher.
- Experience with Microsoft Office (Word, Excel, PowerPoint).
- Knowledge of ICH guidelines, experience with Phase I-III clinical trials, CDISC reporting standards and FDA/NDA submissions helpful.
- Excellent analytical, organizational, communications, and team skills, and attention to detail.
- Ability to perform in an environment which requires support for multiple trials and /or tasks (e.g. ability to multi-task with minimal disruption or loss of significant productivity).
- Ability to work well with minimal supervision.
Note: Viable applicants will be required to pass a background and education verification check.
Targeted Compensation: $84,000 – $117,000
About CPC:
CPC is an academic 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 30 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/
CPC offers:
- Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
- Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
- 10 paid holidays
- 15 – 25 vacation days based on years of service
- Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
- In-suite exercise and relaxation room
- Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
- Flexible and remote work schedules
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 forty and over, 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 at careers@cpcmed.org.