Associate Director, biostatistics - #19528789

Supernus Pharmaceuticals


Date: Feb 23, 2021
City: Rockville, MD
Contract type: Full time
Supernus Pharmaceuticals

Job Summary


The Associate Director of Biostatistics is responsible for directing the biostatistics activities for clinical studies sponsored by Supernus Pharmaceuticals Inc. from trial design, execution, analysis, and data interpretation. Works cooperatively with the Director, in the development of


Standard Operating Procedures (SOPs). Develops statistical methods sections of protocols.


Essential Duties & Responsibilities:



  • Contributes in study level tasks from statistics perspective: selection of study design, selection of end points to meet research objectives, sample size and power


calculation, and analyses methods.



  • Develops or review SAPs, TLF shell and specification, and review CRF's and other study documentations

  • Performs ad hoc statistical analyses, including the statistical programming, for assigned studies; interprets data and provides statistical input to clinical protocols, Clinical Study Reports (CSR).

  • Lead and/or manage both in-house and CRO activities related to statistical analysis, programming and data management.

  • Performs simulations to create mock analyses. Proposes new/novel statistical methodological approaches to improve the efficiency and sensitivity of study


results.



  • Interacts with staff from other operational groups (clinical research, clinical OPs, marketing


and preclinical).



  • Develops biostatistics and data management SOP's.

  • Provides effective guidance and communicates to CRO staff in the production of tables, figures, and listings.

  • Reviews and validates analysis data sets, tables, figures, and listings.

  • Reviews database design, CRF's, and edit checks.

  • Attends FDA advisory committee meeting.

  • Reviews and prepares Integrated Safety (ISS) and Integrated Summary Efficacy (ISE).

  • Reviews CDISC/SDTM and DEFINE.XML.

  • Attends Operations meetings, keeps up-to-date on project issues companywide, and keeps Director informed of project issues.

  • Works under limited supervision.

  • Assists with other duties as assigned.

  • Interacts with clients as needed for project and/or relationship management.


Non-Essential Duties & Responsibilities:



  • N/A


Supervisory Responsibilities:



  • Provides oversight to the data capture and management, and database requirements.


Knowledge and Other Qualifications:



  • Ph.D. with 6+ plus years of experience or MS in Biostatistics with 8+ for Associate years of experience in the pharmaceutical/CRO (Associate) , including significant


interactions with regulatory bodies and experience in central nervous system indication preferred.



  • Experienced in NDA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction.

  • Broad knowledge and superior understanding of advanced statistical concepts and techniques with experience in adaptive designs, longitudinal data analysis, handling missing data using pattern mixture models, sensitivity analysis.

  • Fluent in SAS data step programming including SAS macro, familiarity with other packages (e.g., nQuery Advisor, R).

  • Familiarity with ICH guideline and FDA other regulatory authority guidance.

  • Excellent written and oral communication skills including grammatical/technical writing skills.

  • Excellent attention and accuracy with details.

  • Familiarity with statistical methods that apply to Phase I-IV clinical trials.

  • Strong organizational skills.

  • Ability to solve moderately complex problems (identify, propose & implement


solutions).



  • Ability to work in team situations.

  • Demonstrated strong individual initiative.

  • Ability to effectively manage multiple tasks and projects.

  • Ability to lead and co-ordinate the work of small teams.

  • Ability to work in a fully self-directed manner


Other Characteristics:



  • Authorized to legally work in the United States without visa sponsorship.

  • Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors,


customers and others.



  • Ability to work independently and as part of a team.

  • Ability to maintain high ethical standards of integrity and quality.

  • Capable of being innovative and dynamic in approach to work.


Physical Requirements / Work Environment



  • Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects.


Sedentary work involves sitting most of the time.



  • The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer


screen, iPad, or other electronic device; and extensive reading



  • The worker is not substantially exposed to adverse environmental conditions


Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard


to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic


protected by law.

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