- 6 month remote potentially renewable contract; must be able to work pacific time zone hours CDISC experience required NDA submission big plus • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications. • Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files. • Perform quality control for SAS programs and other study documents (e.g., presentations and reports). • Maintain complete and auditable documentatio...

- 6 month remote potentially renewable contract; must be able to work pacific time zone hours CDISC experience required NDA submission big plus • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications. • Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files. • Perform quality control for SAS programs and other study documents (e.g., presentations and reports). • Maintain complete and auditable documentatio...

The Lead Biostatistician for product facing work is responsible for leading statistical activities of clinical studies. Works closely with cross-functional team members to ensure their clinical studies are appropriately planned, have the required statistical power for success, comply with Regulatory requirements and Amgen standards, and maintain statistical, as well as operational, integrity throughout the life of the study. Works closely with the Global Statistical Lead to ensure their study aligns with the overall product strategy. Also works closel...

*Initial 6-month contract, remote, and potentially renewable Summary We are looking for experienced statisticians who can quickly step into hands-on, detailed analyses with minimal training. Candidates need to be comfortable working in a fast-paced SAS® programming environment on complex studies across many therapeutic areas, and have at least 5 years of pharmaceutical industry experience. CRO experience is preferred. Typical tasks include (but aren’t limited to): • Writing/reviewing Statistical Analysis Plan text and Table, Listing, Figure (TLF)...

- 12 month remote renewable contract Top 4 Must Have Skill Sets: * SAS experience * Pharma industry experience * Experience with claims databases * Statistical Analysis experience Work under the direction of Medical Affairs Statistics Disease Lead. • Actively provide statistical support to the Medical Affairs Department. • Provide statistical support for publications, presentations, posters at medical meetings and any other requests not covered in the clinical study report. This includes meta-analysis, multivariate analysis, use of graphical...

- 12 month remote renewable contract At least 8 years of hands-on experience in Stat Programming, with no employment gaps. Note, positions mostly providing oversight of outsourced projects are not considered hands-on At least 4 years hands-on experience working on SDTM and ADaM data sets Hands-on experience in oncology and submissions (meaning, preparing metadata for a study and/or working on an ISS or ISE) Strong communication skills, both written and verbal Demonstrated attention to detail and focus on quality, supported by examples Demonst...

The Senior/Principal Biostatistician works independently in the production and quality control of analysis plans, reports, derived datasets, tables, listings and figures, provides statistical advice to clients and fulfills the project primary role within a designated project team. Key Accountabilities: Coordinate and lead a project team to successful completion of a project within timelines and budget Interact with clients as key contact with regard to statistical and contractual issues Perform QC of derived datasets, tables, figures and data li...