Director of Biostatistics (REMOTE, PST/MST - Up to 200/HR)

Strictly seeking W2 candidates on PST/MST ONLY

*MUST HAVE EXPERIENCE IN: Phase 1 and PK Analysis/Planning*

Candidate will plan the PK analysis with Scientists & interpret the results. Needs stats experience in Phase 1. Candidate expected to do at least 50% contribution on Phase 1 studies

Primary Responsibilities:

• Performs sample size and power calculations.
• Reviews Case Report Forms (CRFs/eCRFs).
• Develops Statistical Analysis Plan (SAP) and creates table, listing, and figure shells.
• Codes complex statistical analyses using good coding practices.
• Interprets results and writes sections of documents; presents results.
• Provides statistical analyses for decision making, regulatory submissions and interactions with regulatory agencies.
• Develops and assists in maintenance of department tools, templates, guidelines, SOPs, and systems.
• Provides statistical input into other disciplines' activities and participates in interdepartmental processes.

Education/Experience/Skills:

• PhD in (bio) statistics required. An equivalent combination of relevant education and applicable job experience may be considered. Minimum of 7 years' progressively responsible experience in clinical research with a focus on biostatistics.

Must possess:

• Knowledge and understanding of SAS programming and at least some other significant statistics software (e.g., R, S-Plus, PASS) is a plus.
• Ability to code complex statistical analyses; familiar with good coding practices.
• Working knowledge of FDA regulations, ICH GCP guidelines, and the drug development process.
• Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required.
  

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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