Principal Biostatistician

Fully Remote Principal Biostatistician 6 Month Contract

Essential Duties and Responsibilities

• Act as the lead or contributing statistician on the clinical development program, individual studies, and associated project teams.
• Produce and deliver statistical analysis strategy for clinical development programs (including target product profiles), clinical development plans, endpoint strategy, statistical analysis plans (SAPs), reports and manuscripts, and statistical analysis required to support development programs.
• Provide statistical input into all phases of clinical development (ensuring regulatory compliance and compliance with good statistical practice) and provide statistical input into the reporting of clinical trial results. CSRs, manuscripts, regulatory submissions, and presentations to Congresses
• Provide statistical input into protocol and CRF development (e.g., trial design, sample size determination and power analysis, randomization, statistical methods for protocols, and edit checks for clinical trial data), annual safety reporting, and development and updating of program level investigator brochures.
• Oversee and manage CRO statistical and programming activities to ensure quality deliverables within timelines.
• Author/review DMC charter and serve as an internal independent statistician for assigned clinical trials.
• Analyze clinical trial data and produce accurate results that represent the outcome of the trial, validate statistical outputs, and accurately interpret and clearly communicate statistical results and concepts to non-statisticians.

Education

• PhD in Statistics or related fields with a minimum of 2 years (minimum of 4 years for Master’s degree) of post-graduate experience in clinical trial setting in the pharmaceutical industry.

Experience, Knowledge, Skills and Abilities

• Working Knowledge of FDA, EMA, and ICH guidance for drug development
• Excellent working knowledge of CDISC requirements for regulatory submissions, including expertise with preparation and submission of data in STDM, ADaM, and SEND data standards and associated documentation.
• Excellent presentation skills to interpret statistical concepts and results to clinical development team.
• Proficient in SAS programming and at least one other programming language such as R for statistical analysis.
• Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required.
• Excellent verbal and written communication skills
• Detail and process oriented.
• Must be able to demonstrate strong project management skills.