Job Opportunities

Current Openings:

How to Apply

Please submit your resume with cover letter to the email: hr@biopier.com (include the position title and job code, direct applicants only)

Senior/Principal Biostatistical Analyst (Job Code: BA2)

BioPier is looking for a Senior/Principal SAS Programmer to join our growing consulting team. The candidates will be working on the analysis and reporting of Phase I-IV clinical trial studies for biopharmaceutical companies.

Responsibilities:

You will lead statistical programming studies, manage timelines and resources, and work on one or more of the following tasks based on your expertise.

CDISC SDTM Tasks

Follow the CDISC SDTM Implementation Guide, write SDTM mapping specifications and SAS programs to produce or validate CDISC-compliant SDTM datasets;
Review and annotate eCRFs (Case Report Form).

Efficacy/Safety Analysis Tasks

Follow statistical analysis plans(SAP), develop AdaM dataset specifications and write SAS programs to produce ADaM datasets;
Produce or validate summary tables, data listings, and graphs (TLGs) using SAS software;
Build programming specifications for the ADaM database based on the statistical analysis plan and report specifications.

Regulatory Submission (eCRT/eCTD) Tasks

Produce/validate eSubmission (define.xml) packages for FDA and PMDA, write eSubmission Reviewer's Guide.

Other Tasks

Develop programming procedures, system macros for process improvements;
Write or review standard operation procedures for biostatistics or SAS programming activities.

Qualifications:

Minimum Bachelor's degree in (bio)statistics, computer science, biomedical science, or related field; an equivalent combination of relevant education and applicable job experience will be considered;
Minimum 2+ years of SAS programming experience within CRO or biopharmaceutical companies. Years of other programming experiences will be considered as well;
Excellent and proven SAS programming and statistical analysis skills using SAS BASE, STAT, GRAPH, and MACRO. SAS Certified Base and/or Advanced Programmer is a plus.

Compensation:

We offer competitive compensation based on your experiences. We offer paid holidays, 3-week vacations, medical/dental insurance, 401k, bonus, on-site gym, and many other benefits. We have a friendly and flexible working environment. We sponsor H1B visa and Green card.

Lead Biostatistician (Director-Level) (Job Code: LeadBiostat)

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.

Responsibilities:

Act as the statistical analysis subject matter expert for Phase I-IV studies
Develop statistical analysis plans (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, timelines, and resources

Qualifications:

Minimum Qualifications:

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.

Preferred Qualifications::

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.

Compensation:

We offer competitive compensation (130k to 200k plus bonus) based on your experiences. We offer paid holidays, 3-week vacations, medical/dental insurance, 401k, bonus, on-site gym, and many other benefits. We have a friendly and flexible working environment.

Lead SDTM Programmer (Job Code: LeadSDTM)

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.

Responsibilities:

As an 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 timelines and resources, and interact with clients
Produce SDTM define.xml Package including Reviewer's Guide
Support regular SAS programming activities (see Biostatistical Analyst).

Qualifications:

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 SAS BASE, STAT, GRAPH, and MACRO. SAS Certified Base and/or Advanced Programmer is a plus.