Our client is seeking a Senior or Principal Statistician to support Synthetic Control Arm (SCA) projects, leveraging statistical expertise and programming skills to execute, manage, and QC these innovative clinical trial solutions. SCAs use advanced statistical methods to create external controls, ensuring baseline balance and augmenting clinical trials with patient-level data from previous studies. With access to thousands of historical clinical trials in their Enterprise Data Store, this role will play a critical part in optimizing trial design and execution. The ideal candidate will have experience in late-phase oncology trials, strong proficiency in SAS, CDISC, and ADaM, and a background in regulatory submissions.
location: New York, New York
job type: Contract
salary: $110 - 120 per hour
work hours: 9 to 5
education: Doctorate
responsibilities:
- 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:
- PhD degree or equivalent, in Statistics or Biostatistics. Exceptional candidates with MS degree in Statistics or Biostatistics may be considered
- 3+ years analyzing and interpreting clinical trials data and/or managing/QCing SAS programming in the Pharmaceutical & Biotech industry. Experience with additional programming languages is a plus.
- Solid ability in the design, analysis, and interpretation of clinical trials, particularly in time-to-event analyses, propensity score or other matching or weighting methods and/or Bayesian approaches to clinical trials with an appetite for innovation
- Familiarity with drug development life cycle and experience with the standardization, integration, analysis and reporting of clinical trials' data.
- Regulatory submissions knowledge and experience utilizing define.xml and other submission documents is a plus. Understanding of FDA guidelines.
- Strong SAS skills and knowledge of CDISC standard. Experience working with and guiding statistical programmers. Experience in Phase II/III Oncology trials a plus
- Excellent written and verbal ability, including the ability to be persuasive to a technical or non-technical audience
- Ability to work in a fast paced environment and work on multiple projects at the same time
skills: ADaM, CDISC, SAS Macro, SAS-Base, 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.
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