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.
This position provides statistical support for assigned studies. Also responsible for leading study design, data analysis, and interpretation of results with some independence. The Lead Statistician may also participate in interactions with funding and regulatory agencies with supervision. Contributes to process improvement of the biostatistics function and ensuring compliance at every level. Provides leadership in cross-functional teams and mentors junior staff members.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Reviews programs and output (TFLs) for the analysis and reporting from clinical and pre-clinical studies.
• As project statistician, supports the Biostatistics and Data Sciences team maintaining consistency across a program in their study documents and acts as liaison with clinical operations/medical.
• Develops Statistical Analysis Plans for studies.
• Collaborates with clinical development teams to determine protocol design and sample size calculations.
• Actively participates in clinical study team meetings. Leads departmental study subteams.
• Prepares and reviews statistical and results sections of clinical study reports and provides input into regulatory filing documents.
• Supports the design of PK, clinical, and pre-clinical studies.
• Participates in the evaluation of and response to Government RFPs, BAAs, RFIs and RFAs in support of new and existing products.
• Provides statistical guidance, oversees study conduct and works with CROs to ensure successful completion of studies.
• Authors, with other Clinical Development staff, posters and manuscripts for associated clinical study work.
• Provides statistical consultation and analyses as required to departments outside Clinical Development.
• Serves as study biostatistician for clinical protocols.
• Works collaboratively with Clinical Operations and Clinical Development, Data Management, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Learns to manage a study’s resources and timelines.
• Works with statistical programming and other functions for the development and maintenance of standard mock tables, programming standards, data review and reporting tools, and any other statistical applications as appropriate.
• Supports the development of biostatistics SOPs and standard processes.
• Develops leadership skills and stays up to date with evolving industry standards, statistical concepts, regulatory expertise, and biological/therapeutic area knowledge.
• Mentors Biostatistics, Data Management and Statistical Programming staff on processes and statistical needs as relevant to their roles.
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.
• MS: At least 8 years of relevant biostatistics experience in a pharmaceutical, biotech, CRO or other clinical research setting.
• PhD: At least 6 years of relevant biostatistics experience in a pharmaceutical, biotech, CRO or other clinical research setting.
• Knowledge of statistical computing software including SAS. Experience with other software such as R, JMP, and nQuery is a plus.
• Experience with early phases of clinical trials; Phase 3 experience is a plus.
• Expert knowledge of GCP, ICH, FDA and HIPAA regulations and guidelines.
• Experience with vaccine and/or biologics development is a plus.
• Past interactions with regulatory agencies is a plus.
• Hands on and solid knowledge in CDISC standards, including SDTM and ADaM, controlled terminologies, aCRF, cSDRG, ADRG, and define.
• Demonstrated organizational, analytical and problem-solving skills, as well as ability to prioritize tasks.
• Extensive experience with performing regression analysis, ANOVA, sampling techniques, categorical data analysis, statistical process control, experimental design and exploratory data analysis.
• Demonstrated ability to write statistical analysis plans, mock tables and specifications to meet regulatory and company standards.
• Ability to effectively oversee work of outsourcing partner.
• Excellent organizational, analytical and problem-solving skills.
• Excellent written, verbal, and interpersonal communication skills.
• Ability to work as part of a project team.
• Experience with SQL, Microsoft Excel, Access and Word.
• Responsibility for matrix management and mentorship within Biostatistics and Data Sciences team.
• Independence for all initial biostatistical tasks is expected.
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.