- Ensures consistency among protocols within a project, and provides certification for the protocol review check list. Works with project team to select an appropriate study design to meet study objectives, contributes to decisions regarding data collection instruments. Conducts comprehensive review of protocol to ensure quality. Responsible for conducting research and identifying key parameters for sample size estimation.
- Independently determine appropriate statistical methodology needed in support of study objectives; develops and authors the statistical methods section of the protocol. Responsible for randomization for routine and non-routine studies. Works with external partners, including contract research organizations, drug supply, and other groups, to effectively implement the randomization schedule as planned.
- Actively participates in meetings to identify scientifically appropriate data collection instruments and database design requirements (e.g., SAS, MS Access, Excel) to ensure that the data evaluated are free of bias, contain maximum information (minimum variance), and satisfy analysis requirements.
- Demonstrates extended understanding of statistical concepts and methodologies. Demonstrates ability to apply statistical knowledge to solve real-world problems. Demonstrates the ability to evaluate alternative statistical approaches, to make recommendations based on sound statistical reasoning, and to influence non-statisticians to accept the analytical approach.
- Reviews identified or anticipated technical or data related issues arising in the design, conductor analysis of clinical trials or other scientific research. Approves and implements alternative analysis strategies or other recommendations to address these issues. Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
- Works with project team to develop strategy for data presentation and scientific arguments. Ensures consistency of data presentations and scientific/statistical arguments among reports within a project. Responsible for statistical methods and relevant sections for major deliverables such as protocols, analysis plans, study reports and scientific publications. Responsible for accurate interpretation of analysis results. Responsible for high quality deliverables.
- Prepares oral and written reports that effectively communicate results of scientific research to the project team, AbbVie management, regulatory agencies, or individual investigators. Responsible for consistency between deliverables for the same compound and/or within same therapeutic area. Responsible for accuracy and internal consistency of report of publication, including text, tables, listings, and figures. Ensures as applicable that guidance and template format for protocol & analysis plans
- Works collaboratively with members of multi-function teams to complete project deliverables per agreed timelines. Keeps management informed on important scientific/statistical issues that may arise, in a timely manner. Provides responses to routine and non-routine questions from clients, and independently pursues analyses suggested by the data.
- Represents Data and Statistical Sciences (DSS) or Biometrics on assigned project team(s) to provide functional area input to compound/drug development. Serves as a liaison between the project team and DSS or Biometrics to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional area.
- Maintains technical skills and increases own knowledge of new statistical methodology or areas of application through use of the scientific literature and attendance at professional meetings. Presents own statistical research or review of the statistical literature at meetings and seminars. Demonstrates a high degree of responsibility in maintaining Statistics / Biometrics department standards, GxP compliance, and best operating practices.
- MS or PhD in Statistics, Biostatistics or a highly related field.
- At least 4-6 years (PhD) or 8-10 years (MS) of experience in pharmaceutical development and applied statistics/statistical consulting required.
- statistical modeling and inferential statistics; actively seeks to acquire knowledge concerning the use of new/novel statistical techniques and their biometric/ biopharmaceutical applications.
- Pharmaceutical or related industry experience with nonclinical, clinical or pharmacology studies, as appropriate, including experience and understanding of drug development in a regulated environment preferred.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Job Type: Experienced