Senior/Principal Biostatistician
6 Month Contract (may extend)
$110-$120PH
REMOTE
Wev are seeking a talented Biostatistician to support innovative Synthetic Control Arm (SCA) projects, leveraging AI to optimize clinical trials using historical patient-level data. This role is ideal for statisticians passionate about hands-on statistical analysis and innovation.
MUST HAVE
- Late-phase Oncology experience (95% of projects).
- Drug development experience required
- Regulatory submission experience
- Strong SAS, CDISC, ADaM required (R is a plus)
- PhD
location: New York, New York
job type: Contract
salary: $110 - 120 per hour
work hours: 9 to 5
education: Doctorate
responsibilities:
Your Mission:
- Leverage your statistical expertise and programming skills to execute, manage, and QC synthetic control arm (SCA) projects and further develop innovative approaches to optimize clinical trials. An SCA is an external control created using appropriate statistical methods to achieve baseline balance and to augment clinical trials with patient level data from previous clinical trials. We have access to thousands of previous clinical trials available in our Enterprise Data Store which may be the basis of this work.
- Work collaboratively with data standardization subject matter experts, statistical programmers, biostatisticians, and other groups to assist cross trial integration of historical data and assess adequacy to support project specific research objectives.
- Create and review protocols, statistical analysis plans, and other clinical trial related documents.
- Work collaboratively with the statistical programming team to support, develop and review specification for ADaM datasets and perform and guide statistical programmers, and/or QC statistical analysis and reporting of both efficacy and safety clinical trial data utilizing SAS programming.
qualifications:
Required:
- PhD degree in Statistics or Biostatistics.
- 3+ years of experience analyzing and interpreting clinical trial data and/or managing SAS programming, with expertise in CDISC and ADaM standards within the pharmaceutical and biotechnology industry.
- Experience in Phase II/III Oncology trials
- Experience with clinical trial design, analysis, and interpretation, with a focus on time-to-event analyses, matching/weighting methods, and Bayesian approaches.
- Experience with regulatory submissions, define.xml and other submission documents
- R programming
skills: ADaM, CDISC, SAS Macro, SAS/STAT, SAS-Base, SDTM, Statistical Analysis Plan, Statistical Programming, Biostatistical Analysis
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.
