Director, Quantitative Science (Post - Approval)

Who We Are

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

Summary

The Director Quantitative Science (Post-Approval) is a self-sufficient and high-impact position focusing on leading cross-functional teams supporting the statistical needs in the post-approval area in terms of rapid response for critical requests, exceptional communication and collaboration abilities, a broad practical perspective on contributing to the success of medical affairs and market access efforts, and technical leadership in formulating, interpreting, and communicating statistical approaches.

Specifically, the applicant must have demonstrated the following qualifications.

• Subject matter expert in related technical areas such as real-world data/evidence (RWD/E), patient centered outcomes (PCOs), health economics and outcomes research (HEOR), and contemporary statistical modeling techniques (e.g., prognostic / predictive modelling, indirect treatment comparison, Bayesian analysis, etc.).
• Proficient data science analytical and programming skills.
• Excellent matrix team leadership, interpersonal skills, and project management capabilities.

The position’s primary responsibilities will include the following

• Leading a Data Science program / project team.

 

• Directing / supporting all statistical activities from design to ad-hoc analysis to reporting and presentation.

 

• Performing all tasks from statistical thinking to programming.

 

Responsibilities

• Functioning as a statistical / analytical subject-matter expert in all post-approval areas, especially Medical and Market Access / HEOR.

 

• Ensuring creative and effective statistical methodologies are identified and implemented in designs, analysis plans, and reporting and interpretation of post-approval study outcomes and statistical analyses.

 

• Providing operational statistical leadership for the post-approval study team’s and Market Access team’s statistical needs in HEOR, health technology assessments (HTAs), price negotiation and reimbursement dossiers, observational research, and other medical and scientific communication activities.

 

• Serving as the lead for the Data Analysis Working Group (DAWG), Data Analysis and Reporting Team or Statistical Analysis Review Team (DART) for a therapeutic area (TA) or a program.

 

• Collaborating effectively with internal stakeholders from Clinical Development, Medical Affairs, HEOR, and RWE teams and external stakeholders (e.g., regulators, payers, review boards, co-authors, CROs, etc.).

 

• Working proactively and efficiently with the other Quantitative Science leads, Clinical Development statistical leads, and other colleagues within Data Science to organize, plan, manage, and control deliverables against goals and timelines. 

 

• Contributing to clinical study reports (CSRs) and related periodic reports, and to authoring or co-authoring methodological or study-related presentations, posters, and manuscripts.

 

• Understanding modern drug discovery, research, development, and post-approval principles and processes.

 

• Contributing to development, improvement, and implementation of the departmental and cross-functional processes, working instructions, guidelines, and document management systems.

 

Education & Experience

• S. in Biostatistics, Statistics, Data Science, Pharmacoeconomics, or similar field required.

 

• D. in Biostatistics, Statistics, Data Science, Pharmacoeconomics, or similar field preferred.

 

Minimum Qualifications

A minimum of 8 (PhD) – 10 (Master’s) years’ experience in pharmaceutical and/or biotech industry.

• at least 5 years of working experience in post-approval, RWE, or market access/HEOR areas.

 

Preferred Qualifications

 

Overall

• Must be able to effectively lead and collaborate with cross-functional teams in the realization of clinical programs and initiatives from study design to presentation of results.

 

• In-depth knowledge of Market Access / HEOR statistical needs and statistical methodology, as well as hands-on data analysis experience.

 

• Must be able to provide technical and tactical support for cross-functional Medical Affairs and Market Access / HEOR programs including registries, burden of Illness / natural history of disease for regulators, payers, and clinicians.

 

• Must be able to work effectively in a constantly changing, diverse, and matrix environment.

 

Statistics

• Advanced knowledge of theoretical and applied statistics or other related data sciences.

 

• In-depth knowledge of statistical analysis methods, especially on data originated from post-approval areas, especially Medical Affairs and Market Access / HEOR.

 

• Solid programming skills including SAS, R, Python and other statistical software packages.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.