Job Details

SUMMARY/JOB PURPOSE:

Provides leadership within biostatistics function to develop and execute statistical strategy, design and analyses for clinical trials in all phases. Applies sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements. Develops and/or applies statistical theories, methods and software. Partners in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or reporting of data. Develops and implements biostatistics department policies, standards, practices and work-instructions in coordination with department leader and leaders in other functions. Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success. Represents biostatistics function in interactions with institutional review boards, ethics committees, and health agencies. Manages timelines, deliverables and budgets of contract research organizations.

Essential Duties And Responsibilities:

1. Work with department head to develop and implement department standards and practices.
2. Direct the statistical design, conduct, and analysis of clinical trials in all phases.
3. Review protocols and case report forms for soundness of trial design.
4. Review and or author statistical analysis plans for all phases of a trial.
5. Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
6. Direct the development, validation and summary of integrated safety and efficacy summaries.
7. Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements.
8. Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development.
9. Contribute to the development of Requests-for-Proposals.
10. Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
11. Responsible for all statistical oversight within a therapeutic area.

Supervisory Responsibilities:

No supervisory responsibilities.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

1. BS/BA degree in Statistics/Biostatistics or related discipline and a minimum of thirteen years of related experience; or,
2. MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of eleven years of related experience; or,
3. PhD in Statistics/Biostatistics or related discipline and a minimum of eight years of related experience, or;
4. Equivalent combination of education and experience.
5. May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

1. Managed and or supported clinical trials, preferably in the therapeutic area of oncology and in the biotech/pharmaceutical industry.
2. Preferably led a phase III clinical trial.
3. In-depth knowledge of CDISC standards.
4. Management and statistical analysis of data obtained from Phase I IV clinical studies in support of US NDAs.
5. Direct experience with FDA/EU Authority preferred.
6. Typically requires a minimum of 15 years of related experience and/or combination of experience and education/training.

Knowledge/Skills:

1. Comprehensive and detailed knowledge of: statistical experimental designs, analyses and clinical trial requirements, particularly pertaining to oncology trials.
2. Developed/reviewed SDTM/ADaM specifications.
3. Excellent knowledge of FDA/EU statistical guidelines.
4. Management and statistical analysis of data obtained from Phase I IV studies in support of NDAs.
5. Must have experience in state-of-the-art data organization and statistical analyses using statistical software such as: SAS, EAST, nQuery, Cytel Studio.
6. Guides the successful completion of major programs, projects and/or functions by identifying and implementing appropriate techniques and evaluation criteria.
7. Has understanding of other disciplines such as data management, clinical operation, clinical science, regulatory affairs and drug safety.
8. Project management and contract negotiation with outside vendors.
9. Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve these goals in creative and effective ways.
10. Develops technical and/or business solutions to complex problems.
11. Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
12. Applies strong analytical and business communication skills.

JOB COMPLEXITY:

1. Works on significant and unique issues where analysis scenarios require an evaluation of intangibles.
2. Works on complex issues where analysis scenarios require an in-depth knowledge of the company.
3. Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
4. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
5. Ensures budgets and schedules meet corporate requirements.
6. Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.