Responsible for leading the statistical design and analysis activities for clinical trials assigned by the Head of Biometrics. Participates in analysis planning for clinical trials, statistical input to clinical study reports, and statistical support to drug safety, medical affairs and pharmacology. Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.
*Position can be based in San Diego, CA OR Princeton, NJ*
- Leads collaborative efforts to provide statistical support for assigned projects
- Performs sample size and power calculations.
- Reviews Case Report forms (CRFs)/eCRFs to ensure completeness and accuracy
- Develops Statistical Analysis Plan (SAP) and create table, listing, and figure shells.
- Performs statistical analysis as defined in SAP.
- Independently provides the statistical input required in the design, conduct and analysis of assigned projects
- Learns new statistical methods and applies new skills to future projects.
- Prepares reports that summarize the analysis of research data, interprets the findings and provides conclusions and recommendations including statistical analyses for decision making, regulatory submissions and interactions with regulatory agencies.
- Provides training on advanced statistical methodologies to the biostatistics staff
- Develops complex statistical analyses programs using good programming practices.
- Applies sound and innovative 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 R&D teams in the design and interpretation of results
- Keeps up to date with Medical/Clinical literature 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 participates in interdepartmental processes.
- Perform other related duties as assigned.
- Ph.D. in Statistics is preferred, Masters level with extensive experience will be considered.
- Minimum of 8-10 years of experience as lead statistician on clinical trials in pharmaceutical industry with increasing responsibilities.
- Solid knowledge of Statistical Analysis System (SAS) programming
- Knowledge of statistical software (e.g., R, S-Plus, nQuery, EAST).
- Experience in programming complex statistical analyses
- Extensive working knowledge of FDA regulations, ICH GCP guidelines, and the drug development process.
- Solid command of the English language and excellent verbal and written communication skills
- Ability to consistently demonstrate leadership qualities and ability to manage project responsibilities independently across a variety of different projects.
- Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.
- Excellent interpersonal and networking skills with the ability to build cross functional relationships
- Able to objectively evaluate situations and make recommendations to meet project goals.
Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways, exercising judgment in selecting methods, techniques and evaluation criteria for obtaining results. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Determines methods and procedures on new assignments and may coordinate activities of other personnel.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity