1. Participates as lead biostatistician on single or multi-protocol projects and/or team biostatistician on large, complex, multi-protocol projects (such as an NDA or BLA), providing the following functions:
a. Develop statistical methods sections of protocols (or team biostatistician's
review of protocols); review of case report forms.
b. Develops analysis plans, AROs, and table shells.
c. Responsible for coordinating with Medical Operations team members in development of Annotated Report Outlines (ARO)
d. Provides specifications for tables and may develop and specify analyses files, both for individual studies and in preparation of major regulatory documents, such as, IND, NDA, BLA, and PMA; reviews output and reviews tables.
e. Coordinates activities between BIOS, SPS, and RDQC on carrying out specified analysis.
2. In lead biostatistician role (on projects with two or more biostatisticians), provide general direction of work of other biostatisticians to ensure efficiencies and to ensure consistencies across studies (or across NDA components, as appropriate).
3. Interprets analyses and writes statistical and/or joint clinical and statistical study reports, as well as ISE, ISS, and Section 10 components of NDAs.
4. Interacts with staff from other operational groups (e.g., clinical, medical, data management).
5. Interacts with clients on projects; leads biostatistics discussion at client meetings.
6. May interact with FDA on client projects.
7. Conducts statistical analysis utilizing SAS? and other statistical software packages.
8. May serve as Project Manager as needed on Statistical Operations project.
9. Produces sample size estimates and provides power calculations, as needed
10. Participates as expert reviewer on deliverables for specific projects; advises other biostatisticians on moderately complex statistical issues; and may oversee the preparation and submission of the statistical components of major FDA regulatory documents.
11. Participates in development of departmental processes and training, jointly with departmental managerial staff.
12. May give presentations to potential new clients.
13. Performs short-term administrative and technical functions assigned by the Director (or supervisor), including participating in task forces and giving presentations to the Biostatistics staff, other departments or at professional meetings.
Ph.D. degree in Statistics or Biostatistics and ? 2 years working biostatistical experience in the clinical trials environment.
M.S. degree in Statistics or Biostatistics and ? 5 years working biostatistical experience in the clinical trials environment.
Excellent written and oral communication skills including grammatical/technical writing skills Excellent attention and accuracy with details
Familiarity with moderately complex and some complex statistical methods that apply to Phase I-IV clinical trials
Strong organizational skills
Ability to lead and co-ordinate the work of small teams
Familiarity with PC and VAX computing systems
Strong working knowledge of SAS?, familiarity with other packages (eg, S+, SUDAAN, StatXact)
Proficient at solving complex scientific problems (identify, propose & implement solutions)
Ability to work in team situations
Shows strong individual initiative
Strong commitment to teamwork and quality
Ability to effectively manage multiple tasks and projects
The following is a position posting for the Biostatistics Department. Qualified and interested applicants may send their resume to: firstname.lastname@example.org Be sure to mention position and your school in the Subject section of the email. Resumes may be cut and pasted to the email or sent as a Word attachment.