Current Openings (Multiple Positions, Full-time, Contractor)
How to Apply
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Lead Biostatistician (Director-Level)
BioPier is looking for a Lead Biostatistician (director-level) to join our growing consulting team and lead our biostatistical services. The ideal candidate would be working from the Boston area.
- Act as the statistical analysis subject matter expert for phase I-IV studies
- Develop statistical analysis plan (SAP) and TFL shells for CSR, IA, ISE, ISS, as well as safety reports such as EURMP, SWG etc.
- Perform statistical programming and analysis; Interpret statistical results; Prepare clinical study reports - Review and develop specifications for analysis datasets
- Present results to the FDA, and develop responses to regulatory agency requests
- Provide study designs: sample size estimation; patient randomization etc.
- Develop service scope, manage projects, timeline and resources
- Bachelor's degree with 8 plus years of experience, Master's degree with 3 plus years of experience, or Ph.D. with 2 years of experience is required
- Experience of Phase I-IV clinical trials in the Pharmaceutical or Biotechnology industry AND global regulatory submissions are required.
- Ph.D. with 5+ years of experience in the Pharmaceutical/Biotechnology industry in clinical development
- 5+ years as a study lead working with cross functional teams
- CRO experience
- Strong SAS programming skills and SDTM, AdaM, QA/GCP/ICH knowledge
- Boston area (local) is strongly preferred
We offer competitive compensations (130k to 200k plus bonus) based on your experiences. We offer paid holidays, 3-week vacations, medical/dental insurances, 401k, and many other benefits. We have a friendly and flexible working environment.
Lead SDTM Programmer
BioPier is looking for a Senior /Lead SAS Programmer to join our growing consulting team. The candidates will be converting legacy clinical data into CDISC SDTM format for phase I-IV clinical trial studies.
AS a SDTM data conversion expert, you will
- Lead and manage SDTM conversion projects
- Write SDTM mapping specifications according to CDISC SDTM Implementation Guide (SDTM IG)
- Annotate Case Report Form
- Write SAS programs to produce and validate SDTM datasets
- Manage timeliness and resources, and interact with clients
- Produce SDTM define.xml Package including Reviewer's Guide
- Support regular SAS programming activities (see Biostatistical Analyst).
- Minimum 2+ years of hands-on SDTM conversion / SAS Programming experience within CRO or biopharmaceutical companies
- Very knowledgeable of CDISC regulations including CDISC SDTM, SEND, ADaM, CRT, and their implementation guide
- Minimum Bachelor's degree in statistics, computer science, or related field; an equivalent combination of relevant education and applicable job experience will be considered
- Excellent and proven SAS programming and statistical analysis skills using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACRO. SAS Certified Base and/or Advanced Programmer is a plus
We offer competitive compensations based on your experiences. We offer paid holidays, 3-week vacations, medical/dental insurances, 401k, and many other benefits. We have a friendly and flexible working environment. We sponsor H1B visa and Green card.