Director, Medical Data - King of Prussia, PA, United States - Exelixis

Description

Provides leadership to the biostatistics function and direct management of biostatistics staff in developing statistical strategy, design, and analyses for clinical trials for multiple compounds with a focus on early phase (1/2) trials.

Applies sound statistical methodology to meet key project objectives related to early development including clinical biomarker and translational medicine objectives.

Develops and/or applies statistical theories, methods, and software.

Partners in early clinical development program study design, biomarker strategy and translational medicine strategy establishing standards for clinical conduct, and the collection, management and/or reporting of data.

Recruits, develops, and supervises project statisticians.

Takes a leadership role in developing and implementing biostatistics department policies, standards, practices, and work-instructions in coordination with senior leaders in biometrics and other functions.

Conceptualizes and implements initiatives for process improvement and or standardization for biostatistics activities and deliverables. Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success. Manages timelines, deliverables, and budgets of contract research organizations.
Responsible for all statistical oversight of early development projects.
Provide vision and direction for the development and implementation of department standards and practices and oversite of process improvement initiatives
Provide technical oversight of the statistical design, conduct, and analysis of early phase clinical trials.
Review statistical analysis plans and case report forms.

Lead and directly manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, costs, methods, and resourcing.

Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements and ensure ongoing agreement on project development.

Contribute to the development of Requests-for-Proposals for evaluation of Contract Research Organizations and other vendors providing services for biostatistics, and programming activities.

Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables, and budgets.
Interpret, execute, and recommend modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
Direct management and supervision of biostatisticians.
Indirectly supervise employees in other functions through a dotted line structure or via other subordinate supervisors.

PhD in Statistics/Biostatistics or related discipline and a minimum of 12 years of related experience; Managed clinical trials in the therapeutic area of oncology for at least 5+ years and other therapeutic areas for 10+ years.

Experience managing multiple statisticians.
Knowledgeable regarding FDA/EMA/ICH guidelines for drug development, new methodology in statistics and statistical/clinical data analyses.

Ability to work simultaneously on multiple projects and multiple compounds, and to deliver high-quality work according to tight timelines.

Strong people management and interpersonal skills
Strong conflict management skills

Comprehensive and detailed knowledge of statistical experimental designs, analyses, and clinical trial requirements, particularly pertaining to early development oncology trials.

Has functional understanding of other disciplines such as data management, clinical operations, clinical science, regulatory affairs, and drug safety.

Project management and contract negotiation with outside vendors.

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.

Works on significant and unique issues where analysis scenarios require an evaluation of intangibles.
Works on complex issues where analysis scenarios require an in-depth knowledge of the company.
Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.
Creates formal networks involving coordination among groups.
#The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.

Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

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.

#