Sr. Director, Biostatistics
- Emergent BioSolutions
- Gaithersburg, MD
- Start date
- Mar 2, 2023
- Science/R&D, Biostatistics
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
The Sr. Director, Biostatistics is responsible for the development and oversight of biostatistics, , resourcing, budgets and personnel to ensure the efficient and accurate collection and analysis of clinical trial data. This position develops and implements biostatistics related company policy, practices, and operating procedures in compliance with industry standards ensuring high standards of data integrity and quality to optimize compliance, effectiveness, and efficiency. Participates in establishing drug development strategy and direction.
Provides statistical oversight and guidance for research activities for all phases of Research and Development activities. Liaise with various internal and external groups (Clinical, Non-clinical, Data Management, Regulatory, Pharmacovigilance, and external vendors including CROs and regulatory bodies) for the implementation of statistical input needed for internal data exploration, data management, and regulatory submissions.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Ensure appropriate biostatistics input into and review of critical clinical and non-clinical submission documents including clinical development plans , protocols, statistical analysis plans, data management documentation, integrated statistical analysis plans, tables, figures and listings, clinical study reports , summary documents (including ISS, ISE, Clinical Overview, Clinical Summary), Summary of Product Characteristics, clinical study summaries (for posting to study registries), clinical sections of IND applications, agency meeting briefing packages, Annual Safety Updates, responses to agency questions and other documents that may be assigned.
• Interact with executive leadership to establish vision, execute decisions, manage risk, and influence activities that affect the long-term viability of the BDS department and the company.
• In collaboration with the product development teams and through subordinate management, leads the effective development and implementation of strategies consistent with the company's strategic objectives, and ensures the overall effective operations of the biostatistics group.
• Ensures functional areas are appropriately staffed with employees, consultants, and/or temporary workers who can do, will do, and are developed to do the work necessary for the success of the functional areas and the satisfactions of the workers. Responsible for developing and maintaining department and CRO budgets within corporate fiscal targets.
• Responsible for the supervision and management of Biostatistics staff and contractors, including hiring, motivation, training, coaching/mentoring, and performance evaluation; Provide staff with reliable guidance to succeed and grow.
• Responsible for the development and oversight of biostatistics, and personnel to ensure the efficient and accurate collection and analysis of clinical trial data and other research needs. Develops and implements company policy, practices and operating procedures in compliance with industry standards ensuring high standards of data integrity and quality to optimize compliance, effectiveness and efficiency.
• Ensure coordination between Biostatistics, Regulatory, and eCTD submission group for the preparation and authoring of module 2 and 5 materials, answering questions about the submission data standards, communicating with FDA experts, if necessary. Coordinate response to health authority questions post submission.
• Interact with FDA and other regulatory authorities to ensure clinical studies meet regulatory requirements and to ensure ongoing agreement on project development.
• Senior biostatistical representative on internal executive committees including a protocol/clinical/submission document review committee, strategic-and partner joint-development committees, and drug safety committees.
• Conduct regular departmental meetings; communicate implications of enterprise decisions on department's daily work and priorities.
• Provide input into Vendor selection and management, including writing RFPs, negotiating contracts and defining scopes of work. Liaising between Sponsor Clinical and Data Management or Biostatistical vendors and consultants. Review and monitor vendor budgets and timelines, adjusting if necessary, ensure vendor can meet both planned and unplanned Emergent needs in a timely way. Provide executive leadership for sponsor/CRO activities, relationships, and escalation resolution.
• Provide statistical guidance, assist in the design of all phases of clinical and pre-clinical studies including sample size calculation, and in the preparation of statistical sections of study protocols and clinical study reports.
• Serve as statistical expert at external events, conferences and regulatory meetings.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
- MS/MA or PhD in Biostatistics, Statistics, or related field.
- Minimum 15-20 years of experience in leading biostatistics in clinical research (at various levels and in different capacities, including at least 10 years of progressive functional area management through at least senior director level), including having built the biostatistics function and managing a biostatistical group working on all phases of clinical research and drug development.
- Extensive experience in the pharmaceutical or biotech industry determining appropriate designs, understanding the science and clinical application and analyses for clinical trials. Vaccines and biologics experience is a plus.
- Experience with global clinical programs and filings; proven track record communicating and leading the Biostatistics and Data Science Departmental discussions with the FDA, EMA, and other Global Health Authorities and experience with leading the NDA/BLA or other regulatory interactions and filing activities for the biostatistics and data sciences effort.
- Demonstrated success in collaborating and interfacing effectively with executives, advisory committees, peers, subordinates, project teams, etc. throughout the organization.
- Ability to foster effective working relationships with Medical, Regulatory, Clinical Science, and Clinical Operations internal groups.
- Dynamic leadership skills with proven results orientation. Visionary, and strategic leader with the ability to articulate a vision and strategy in a way that inspires, develops, and motivates teams to achieve results.
- Proven ability to translate strategy into implementation that leads to results; strong track record of performance excellence meeting milestones and objectives.
- Positive, forward thinking leadership that emphasizes collaboration, creativity, and flexibility within the confines of a regulated environment. Ability to change the thinking of or gain acceptance of others in critical situations
- Exceptional ability to foster team productivity, cohesiveness, and collaboration. Proven track record of successfully managing remote and international teams. Demonstrated ability to effectively delegate and monitor delegated work.
- Open, engaging, and transparent work style along with exceptional interpersonal skills for navigating employee relations with diplomacy and tact.
- Demonstrated experience building and managing a biostatistics team as well as managing outside consultants/CROs, including proficiency in project planning and management and proactively anticipating and identifying complex issues and problems.
- Demonstrated high level of technical skill and expertise as pertains to biostatistics and programming, with an understanding of data management and data flow. Ability to provide appropriate, comprehensive, and professional statistical input both internally and externally.
- Ability to deal with competing timelines and multiple assignments by appropriate delegation, setting group priorities, and assignment of resources. Negotiate with business unit clients.
- Demonstrated excellent decision-making abilities with competency in making decisions and resolving problems. Ability to recognize which decisions may have a consequential effect on the project and/or study and to make decisions based on experience, skill, and situation, consulting with and/or informing others as appropriate.
- Exceptional communication (written and oral), negotiation, and organizational skills. Ability to explain and present complex statistical concepts to non-statistical colleagues.
- Ability to determine when to use internal resources or a functional service provider or CRO
- Ability to competently manage a very heavy workload and multiple competing priorities, switching priorities quickly as need change. Must be comfortable working within a rapidly evolving environment
- Expert knowledge of GCP, ICH, FDA and HIPAA regulations and guidelines.
- Ability to program in SAS, R or other software to simulate clinical trial outcomes.
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.
Stock Symbol: EBS
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