Associate Director, Biostatistics

Job Description:

The Associate Director, Biostatistics within Oncology independently reviews entire protocols and interfaces with clinicians and other functions to understand study requirements and study design elements including sample size calculations, analysis methods, and study durations etc. for multiple studies

The incumbent develops and/or reviews statistical documents for multiple clinical trials, including SAPs, TLG shells and specifications of variable derivation. This position supports clinical trial related publications.

The incumbent also provides statistical and validation support for analysis datasets, statistical tables, figures and listings as well as performs and validates statistical analysis. Additionally, this individual will be expected to complete Independent reviews of CSRs and perform data interpretation.

The Associate Director, Biostatistics works with the internal/CRO statisticians and programmers to ensure the highest quality of CRO deliverables and QA of data outputs. This individual will function as lead statistician in global registration trials and manage all related statistical activities which includes leading preparation of inputs for regulatory documents and helping to prepare for meetings with health authorities. This individual will also lead preparation of responses to health authorities including identification and execution of new analysis required for these responses.

The Associate Director, Biostatistics manages contract statisticians in the group and provides mentoring and oversight of the assigned work.

Knowledge/Skills/Abilities Required:

• PhD with 5+ years or MS with 10+ years of experience required in related discipline or in the pharmaceutical industry/CRO environment.
• Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process.
• Experience with CRO oversight and FDA submission preferred.
• Excellent technical writing and verbal communication skills.
• Strong teamwork ability/commitment and individual initiative.
• Strong organizational skills with ability to effectively manage multiple studies.
• Excellent programming skills in SAS or R.