Director Biostatistics

Green Key Resources; Durham (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Green Key Resources seeks a Statistical Science Director to independently guide statistical strategies and activities across pharmaceutical programs. You will lead design, delivery, and interpretation for governance committees and regulatory submissions, and mentor staff while gaining external recognition as a methodology expert.

You will steer statistical thinking for development plans, regulatory strategy, HTA, and commercial presentations, partnering with experts to deliver high-quality

Qualifications

• Advanced degree in statistics/biostatistics or equivalent.
• Proven leadership in directing statistical strategy.
• Experience in clinical trials and regulatory submissions is essential.
• Strong communication and cross-functional collaboration skills.
• Mentors staff and drives technical excellence.

Responsibilities

• Lead statistical design and strategy for development plans and regulatory activities.
• Oversee statistical content for study designs, documents, and submissions.
• Quantify benefit, risk, value, and uncertainty of product profiles in governance settings.
• Provide global leadership and manage internal/external staff.
• Collaborate with CROs to ensure timely, high-quality delivery.
• Represent statistical strategy to external bodies and governance boards.
• Stay current with regulatory guidance and novel statistical methods.
• Mentor and train Statistics staff across projects.

Skills

Statistical leadership

Clinical trials

Regulatory submissions

Data analysis

Mentoring

Education

MSc/PhD in Statistics or related

Tools

SAS

R

Python

Job description

As a Statistical Science Director, you'll leverage your extensive experience in the pharmaceutical industry to independently guide statistical strategies and technical activities. Whether it's designing, delivering, or interpreting data for high-level governance committees or regulatory submissions, your expertise will be pivotal. You'll also have the opportunity to be recognized externally as a methodology expert, leading technical analyses and mentoring less experienced staff. Join us and collaborate across functions to make a real impact!

What you’ll do:

In this role you will be responsible in leading the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects within a product team.

You will provide leadership to statistical staff on the indications/projects so that all work is carried out with regards to clients standards and external regulations; through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions; quantifying the benefit, risk, value and uncertainty of the emerging product profile.

You will apply expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration. You will mentor/coach and support the education and training of statistics staff in the technical arena.

The accountabilities for supporting projects directly include:

• Lead the statistical design and strategy to product development plans, preclinical studies, regulatory strategy, health technology assessment, and/or commercial activities as appropriate for the stage of the product.
• Lead the statistical content and ensure quality for study designs, documents, delivery, interpretation, and submission.
• Quantify the benefit, risk, value, and uncertainty of the emerging product profile and communicate these effectively within the team.
• Provide global leadership to others and direct project work delivered by internal and external staff.
• Partner with CROs to ensure delivery to quality and time.
• Represent company externally which may include health authorities, advisory boards, conferences, workshops, and/or payer interactions.
• Maintain knowledge of statistical methodology in relevant areas and promote, investigate, and implement novel statistical approaches.
• Represent statistical strategy and decision-making at internal governance including review boards, therapy area leadership teams, and ESPC/LSPC.
• Mentor/coach and support the technical education and training of Statistics staff.

The accountabilities for supporting statistical methodological advances are (technical focus):

• In-depth knowledge of technical/regulatory requirements with experience in pharma/healthcare.
• Stay up-to-date and implement novel statistical approaches.
• Experience with and broad awareness of regulatory interactions and/or submissions.
• Excellent communication skills/build strong relationships.
• Nationally recognized externally. Invited to attend or speak at seminars and external meetings. Well-rounded statistician with publications on a range of topic areas. Publications resulting from external collaborations.
• Expert Leadership role able to lead/direct work across a team.

What we’re looking for:

This role requires an individual with outstanding technical skills, leadership, and the ability to guide and support multiple studies while fostering team development and project success.

• MSc/PhD in Statistics, Mathematics (with a substantial statistical component), or a recognized equivalent to a stats MSc.
• Proven track record of independent leadership.
• 5 years of experience in clinical trials is critical for this role.
• Recognized for exemplary technical skills and expert leadership role or national recognition as a statistical technical expert.
• Demonstrated ability to provide cross-study support, overseeing, aligning, and providing technical support for multiple studies.