As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on oncology, cardiology, and bone health. With a strong legacy of scientific excellence and a mission to improve patient outcomes worldwide, they offer a dynamic environment where your contributions will drive real change. If you're seeking a rewarding career that makes a difference, let us help you take the next step!
KEY SKILLS;
CLINICAL TRIAL EXPERIENCE
STATISTICAL ANALYSIS PLANS
DEVELOPING STUDY STRATEGIES
DRUG DEVELOPMENT LIFE CYCLE
R PROGRAMMING
location: Telecommute
job type: Contract
salary: $100.00 - 113.05 per hour
work hours: 9 to 5
education: Masters
responsibilities:
- Lead statistical activities for clinical studies.
- Collaborate with cross-functional teams to ensure study planning, statistical power, regulatory compliance, and integrity.
- Work with the Global Statistical Lead to align study strategies with product strategies.
- Partner with the Study Statistician for operational statistical deliverables.
- Maintain study integrity and quality.
- Support product-level activities (regulatory, publications).
- Provide statistical guidance, review, and contributions to:
- Protocols
- Statistical Analysis Plans (SAPs)
- Tables, Figures, and Listings (TFL) shells
- Data Monitoring Committee (DMC) Charters
- Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) specifications
- Randomization specifications
- Other key study-related documents
- Protocol deviations
- Data quality reviews
- Communications
- Attend and contribute to Clinical Study Team Meetings.
- Provide statistical input for cross-functional study start-up activities (CRF development, database specifications, IVRS specifications).
- Initiate cross-functional meetings (SAP review, TFL shell review, TFL review).
- Provide statistical guidance, review, and responsibility for statistical analysis.
- Perform and document QC of primary and key secondary endpoints in ADaM datasets and statistical analyses.
- Perform data-driven modeling during clinical studies.
- Coordinate and participate in Dose Level Review Meetings (DLRMs).
- Review TFLs for consistency and accuracy.
- Author analysis reports (Flash Memos, CSR results sections).
- Collaborate with the study programming team.
- Manage timelines for statistics-related deliverables.
- Comply with company policies, SOPs, and controlled documents.
- Assist with study and system audits.
qualifications:
Minimum Education/Experience:
- Master's degree in Statistics/Biostatistics or related field with significant statistical content.
- At least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research.
- Or PhD degree with at least 3 years experience.
- Strong communication skills (written and oral).
- Strong understanding of statistical concepts in clinical study design and conduct.
- Ability to apply statistical methodologies in clinical trial analysis.
- Independent leadership of complex or multiple less complex studies/projects.
- Experience in protocol and SAP development, CSR review.
- Excellent English communication skills.
- Strong SAS and/or R programming skills.
- Master's degree in Statistics/Biostatistics or related field with significant statistical content and at least 6 years of post-graduate experience.
- Or Doctoral degree in Statistics/Biostatistics or related field with significant statistical content and 5 years of post-graduate experience.
- Experience in designing, analyzing, and reporting clinical trials.
- Ability to present and defend statistical findings.
- Leadership of at least 3 clinical studies end-to-end.
- Life Cycle Drug Development Experience.
- Ability to work in cross-functional teams.
- Ability to influence decision-making.
- Experience with adaptive clinical trials and innovative study designs.
- Experience with Bayesian statistics in clinical trials.
- Proficient R programming skills.
skills: R Language, Clinical Study Design
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
