Biostatistician Senior or Senior Lead - Clinical Research Service (Remote)
Location: Philadelphia, Pennsylvania US
Job Id: 1459
Position Title: Biostatistician Senior, Biostatistician Senior Lead
Precision for Medicine Oncology & Rare Disease is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.
You will provide statistical support for all phases of clinical development, including writing and reviewing statistical sections of protocols and analysis plans while providing input to clinical development plans, and developing SAS programs.
- You are passionate about health care solutions in rare disease and oncology
- You thrive in a fast paced environment while maintaining a high level of quality
- You love working on a team and providing collaborative input to others, working well with data and project management
- You are comfortable interpreting, communicating and presenting statistical results to non-statisticians providing explanations and answering the statistical or clinical questions to non-statisticians in simple terms
- You are a strong SAS programmer, experienced in data manipulation and statistical analysis
- You have excellent written and verbal communication skills
- You are familiar with biostatistics-related industry standards and regulatory guidelines
What to expect day-to-day:
- Generating randomization schedules and providing sample size calculations.
- Providing input into development of case report forms (CRFs).
- Authoring and reviewing statistical analysis plans, including development of table and listing shells.
- Generating analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS.
- Providing programming support and quality control for SAS Programs and other study documents.
- Providing statistical analysis and reports to Data Monitoring Committees (DMCs) and preparing clinical study reports.
- Reviewing output across programs to ensure consistency.
- Participating in the development and maintenance of SOPs.
- Serving as the primary project team representative, delegating work as appropriate.
- Training and mentoring new statisticians.
- MS or degree in Statistics
- Senior: minimum of 5 years experience.
- Senior Lead: minimum of 7 years experience.
- Knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
- Experience with SAS.
Division: Precision For Medicine
Business Unit: Oncology & Rare Disease
Office Based: Remote
Employment Type: Exempt
Employment Status: Regular Full-time
Work From Home Available: Yes
Country: United States
Community / Marketing Title: Biostatistician Senior or Senior Lead - Clinical Research Service (Remote)
Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
EEO Employer Verbiage:
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2018 Precision Medicine Group, LLC
Location_formattedLocationLong: Philadelphia, Pennsylvania US