Job Location: REMOTE

PURPOSE

Contributes to and leads initiatives for the structure and development of the Biostatistics department. Responsible for both management and technical aspects of the biostatistics elements of clinical trials. Oversees the direction, planning, execution, and interpretation of the statistical data analysis activities related to clinical trials/research (Phase I-IV), including the support of regulatory submission by provision of CDISC standardized study data and support of ISS/ISE analyses. Establishes and approves scientific methods for design and implementation of clinical protocols, analysis methods, analysis presentations and final reports.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Employee performs all, part, and/or any combination of the duties listed below.

1. Responsible for working closely with internal and external functions, such as Programming, Data Management, Regulatory Affairs, and Project Management.

2. Responsible for interacting directly with sponsors as part of the study team.

3. Responsible for the review of and input into the statistical aspects of Clinical Development Materials (Protocols, Regulatory Submissions, CSR etc.) and for providing feedback to the project team and/or sponsor regarding their review both verbally and in written form.

4. Responsible for all aspects of statistical analyses of clinical trials data, Phases I-IV, including development of statistical analysis plan and mock shells; creating tables, listings, and graphs; sample size estimation; randomization schedules; and other relevant tools.

5. Serves as core team member for multiple projects including supervising the initiation, planning, and execution of all statistics related tasks awarded to the department per contract as well as monitoring the operational and financial status of the Biostatistics department's portion of the contract.

6. Coordinates detailed initiation, planning, and execution of statistics phase of project with core team members from other departments and with the project manager.

7. Serves as the Statistical Quality Reviewer for statistical analyses, sample sizes, and outputs generated by other Lotus personnel.

8. Performs QC of any statistical data/outputs received from external vendors/statisticians.

9. Coordinates and develops statistical information for reports submitted to the FDA or other regulatory bodies.

10. Identifies, evaluates and provides solutions for fundamental issues for the biostatistics department and other functional areas as relevant.

11. Remains current with relevant statistical developments and publications including CDISC guidance. Applies this knowledge to current programs.

12. Identifies, evaluates and provides statistical scientific expertise to resolution of issues related to development activities for major functional areas.

13. Provides support to the business in the development of business development and promotional materials and the training of junior biostatisticians and programmers.

14. Participates in corporate development of SOPs, standardization efforts, methods, techniques and evaluation criteria for projects, programs and people. Has responsibility for internal performance management of junior staff, including training, coaching and performance reviews. Acts as a mentor to junior staff.

SUPERVISORY RESPONSIBILITIES

Position may supervise assigned team members or vendors and has responsibility for workflow supervision of staff involved in the provision of statistical services in support of clinical studies. Identify the need for process and quality improvement in the biostatistics department. Communicates with upper management to identify required training and resources.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION and/or EXPERIENCE

Must have a minimum of M.S. in Statistics and a minimum of 7 years of work experience in clinical research in the pharmaceutical field, with experience in Phase 1 through Phase 3 clinical studies. Must be able to demonstrate extensive experience in the design, execution and data analysis of clinical studies.

SKILLS and/or ABILITIES

Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is required. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills. Ability to work effectively and efficiently handling multiple tasks simultaneously. Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity appropriate to the position. Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, SAS, and PowerPoint.

Job Type: Full-time

Benefits:

• 401(k) matching
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Work Location: Remote