Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
Provides statistical oversight and guidance for clinical 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 methodology needed for internal data exploration, research support, and regulatory submissions. Ensure high quality, compliant statistical analyses to produce the statistical analyses needed to support all R&D and to provide scientifically rigorous, regulatory compliant analyses with consistency across the clinical and non-clinical programs and on-time delivery.
A strategic and pro-active role with responsibility for ensuring the function is professionally led and represented both within and external to the company, providing support and expertise to members of the team.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Responsible for the supervision and management of Biostatistical staff and contractors, including hiring, motivation, training, coaching/mentoring, and performance evaluation; Provide staff with reliable guidance to succeed and grow.
• Collaborate and work effectively with multiple departments throughout the organization.
• Conduct regular departmental meetings; communicate implications of enterprise decisions on biostatistical daily work and priorities.
• Take a hands-on role in operational issues, as the demands of the project dictate, serving as lead study statistician on assigned clinical projects, provide statistical guidance, assist in the design of clinical and pre-clinical studies including sample size calculation, and in the preparation of statistical sections of study protocols and clinical study reports.
• 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 parts of IND applications, agency meeting briefing packages, Annual Safety Updates, responses to agency questions and other documents that may be assigned.
• Provide technical oversight and review of CSRs and health authority submissions.
• Serve as SME for statistical input into government or NGO proposals
• Serve as statistical expert at external events, conferences, and regulatory meetings.
• Maintain expertise in state-of-the-art clinical trial design and statistical analyses.
• Provide input into Vendor selection, including writing RFPs, negotiating contracts and scopes of work.
• Liaising between Sponsor Clinical and Data Management or Biostatistical vendors and consultants.
• Review and monitor timelines, adjusting if necessary, to ensure staff or vendor can meet both planned and unplanned Emergent needs in a timely way.
• Liaise 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.
• Lead the team to define and implement Biostatistics standards (SOPs, mock TFLs, biostatistical methods, sample size estimation, section 16.1.9 templates, etc.); maintain and communicate those standards to increase quality and internal efficiency of processes.
• Ensure that the required Standard Operating Procedures and working procedures/processes used in Biostatistics are appropriately implemented and used.
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
• Advanced degree (Master or PhD) in biostatistics, statistics, mathematics, or related quantitative field. Professional Statistical certification (e.g., CStat) an advantage, but not mandatory.
• 15+ years of pharmaceutical industry experience
• 5+ years direct supervisory experience
• Experience with vaccine and/or biologics development
• Expert knowledge of GCP, ICH, FDA and HIPAA regulations and guidelines; Knowledge of CDISC standards.
• Prior experience leading a team for a therapeutic project/program area
• Excellent understanding of expectations from regulatory agencies, especially FDA and EMA.
• Direct NDA/BLA or other regulatory filing experience, including ISS or ISE experience. Thorough understanding of ICH Guidelines and relevant regulatory requirements.
• Experience working within a dynamic growing environment. Ability to prioritize and handle multiple tasks simultaneously.
• Ability to deal with competing timelines and multiple assignments by appropriate delegation, setting group priorities, and assignment of resources. Demonstrated ability to effectively delegate and monitor delegated work.
• Energetic leadership with strong results orientation; Excellent ability to foster team productivity, cohesiveness, and collaboration. Team builder.
• Open and transparent leadership that emphasizes collaboration, creativity, and flexibility within the confines of a regulated environment
• Must be a strategic thinker and have the ability to solve complex problems.
• Ability to foster effective working relationships with Medical, Clinical Science, and Clinical Operations internal groups; Ability to manage remote teams
• Ability to provide appropriate, comprehensive, and professional statistical input both internally and externally.
• Strong interpersonal skills for navigating employee relations with diplomacy and tact.
• Strong communication (written and oral), negotiation, organizational, and interpersonal skills. Ability to explain and present complex statistical concepts to non-statistical colleagues.
• Knowledge of SAS (Base, Stat, Macro, graph).
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.