Senior Biostatistician

Summary of The Position:

The Senior Biostatistician will be responsible for biostatistical aspects, as applicable, of clinical projects undertaken by FHI Clinical, in accordance with the relevant protocol and other trial-related documentation, ICH GCP (and applicable local adaptations thereof), other local legal requirements, relevant FDA, EMA, and other international guidelines, as well as FHI Clinical (and sponsor, if applicable) Procedural Documents.

The Senior Biostatistician will oversee statistical support, as applicable, for clinical projects undertaken by FHI Clinical. The biostatistician will interact proactively with vendors and clients on statistical issues as they arise. The Senior Biostatistician will communicate with team members regarding trial conduct as it relates to timelines, data quality, and interpretation of results.

Essential Functions:

1. Produce and deliver:

• Statistical analysis plans and appropriate templates for tables, listings and graphs.
• Statistical reports.
• Derived datasets (including specification), tables, listings and figures.
• Sample size calculations.
• Randomization schedules.

Oversee and assist with the preparation of:

• Derived datasets, tables, listings, and figures.
• Post-processing of datasets to Clinical Data Interchange Standards Consortium (CDISC) specifications.
• Statistical trial budgets/quotations.
• Code break envelopes.

Provide statistical support to clients and to other global departments, as required.

Write statistical sections of protocol and input and / or review of Clinical Study Report (CSR).

Provide medical writing assistance as and when required.

Provide support to DSMB meetings, blinded or unblinded.

Assist the Global Head with delegated tasks and responsibilities, including but not limited to support in the preparation and review of Procedural Documents, resource allocation, utilization and forecasting, budget review, bid defenses, etc.

Provides guidance and oversight to direct report(s), including the management of workload, special projects, performance management, salary review, and career development.

Any other duties and responsibilities as may be assigned from time to time.

Knowledge, Skills, and Abilities:

• Excellent judgment and decision-making skills.
• Uncompromising attention to detail and tie ability to think analytically.
• Able to communicate in English effectively and accurately, both orally and in writing.
• Effective time management skills.
• Ability to prioritize workload.
• Effective organizational and negotiating skills.
• Excellent interpersonal skills and problem-solving ability.
• Medical writing skills.
• Highly developed computer skills, including expertise in using biostatistical software packages and the ability to learn appropriate software as necessary.
• Proficient knowledge of therapeutic areas.
• Proficient knowledge of all FHI Clinical Procedural Documents, ICH GCP and local legal requirements, European, FDA and other relevant international guidelines applicable to clinical research.
• Be able to maintain a high level of confidentiality.

Position Requirements

Education: Bachelor of Science degree or higher in statistics, mathematics, biostatistics, public health or related field, or equivalent in terms of formal training and experience.

Preferred Job-related Experience: A minimum of three (3) years of experience as a biostatistician in a clinical research setting.

Additional Eligibility Qualifications: Three (3) to five (5) years of experience in data management.

Preferences: Minimum of two (2) years experience as supervision or manager of staff.

Special Position Requirements: None.

Physical Expectations:

• Typical office environment.
• Ability to sit and stand for extended periods of time.
• Ability to lift or move 5-15 lbs. or 2.26 - 6.8kg.

Travel Requirements:

Expected travel time is less than 10 % for this position.

This job description is not intended to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.

FHI Clinical, Inc. and its subsidiary and affiliate companies provide equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.