Job Description

Job Description

Job Description

Salary: $34/hr - $37/hr

We are looking for a part-time Biostatistician I to join our team!

Are you looking for a rewarding career and opportunity to change peoples 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

In this position you will:

• Support the study design and statistical analysis details for assigned study and tasks, and communicate with project team members as appropriate.
• Provide regular feedback to the supervising biostatistician or Head of Biostatistics on the progress of projects as well as challenges and accomplishments. Seek guidance as needed.
• Participate in the review and validation of 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 with input from more senior level biostatisticians as needed.
• Utilize SAS for programming, validation, analysis, and reporting of clinical data.
• Develop or validate statistical programs to analyze data in SAS.
• Work with other team members to coordinate programming tasks, resolve programming differences or raise issues as appropriate.
• Support the lead biostatistician or programmer in the preparation, review, and submission of interim or final reports of clinical data.
• Adhere to CPC standards and the goals and requirements of each study or task.
• Support the planning, analysis, and presentation of non-study specific requests such as manuscripts, abstracts, grants, ad-hoc sponsor requests.
• May provide statistical support to other functions within CPC (e.g. input to data collection or programming support to operational teams).
• Comply with statistical standard operating procedures (SOPs).
• May participate in the field of biostatistics/clinical trials through membership in related professional organizations, making presentations at professional conferences, and/or submissions to relevant journals.
• Work collaboratively within the biostatistics and programming department and with other departments as required.
• 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 on task related issues with colleagues and project team members in a timely manner.
• Perform other tasks as required.

Here's what you will need to bring to the table:

• Master's degree in biostatistics or related field, with at least 1 year 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.
• Demonstrated comprehension and application of terminology and requirements for study protocols, statistical programs, analyses and reports with respect to GCP, FDA, and ICH guidelines and CPC standards.
• Excellent analytical, organizational, communications, and team skills, and attention to detail.
• Ability to interpret study protocols and Statistical Analysis plans (SAPs) and understand the goals and objectives.
• Ability to perform in an environment which requires support for multiple trials and /or tasks (e.g. multi-task with minimal disruption or loss of significant productivity).

Note: Viable applicants will be required to pass a background and education verification check.

Targeted Compensation: $34/hr - $37/hr; FTE .38 (15 hours per week)

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 35 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.

* 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)

11 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

* benefits subject to meeting eligibility requirements

An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over 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 atcareers@cpcmed.org.

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