Responsible to perform a variety of advanced biometrical, statistical, and technical activities for the design, analysis and interpretation of statistical data in conjunction with a research program based on company products. Collaborates closely with project teams consisting of clinicians, project managers, programmers, data management and other members. Supports (with review) trial planning and analysis activities in support of clinical trials.
Performs sample size and power calculations.
Reviews Case Report Forms (CRFs/eCRFs).
Develops Statistical Analysis Plan (SAP) and creates table, listing, and figure shells.
Performs statistical analysis as defined in the SAPs.
Codes complex statistical analyses using good coding practices.
Applies sound statistical methods to various study designs.
Interprets results and writes sections of documents; presents results.
Provides statistical analyses for decision making, regulatory submissions and interactions with regulatory agencies.
Collaborates effectively with clinical investigators on multiple ongoing projects.
Keeps up to date with Medical/Clinical literature as it as applicable to projects.
Develops and assists in maintenance of department tools, templates, guidelines, SOPs, and systems.
Provides statistical input into other disciplines’ activities and participate in interdepartmental processes.
Bachelors’ degree in in (bio)statistics or related. Higher level education preferred. An equivalent combination of relevant education and applicable job experience may be considered.
Minimum of 5 years’ progressively responsible experience in clinical research with a focus on biostatistics. Desirable experience includes prior role as a statistician on clinical trials and/or clinical research projects that have delivered the agreed-upon end products on time. Pharmaceutical industry experience desired.
Basic knowledge 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.
Able to prioritize work and complete deliverables to timelines with some supervision.
Excellent verbal and written communication skills.
Detail and process oriented.
Skilled at presenting information in a clear, concise manner to all levels within the department.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity