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.
Provides statistical and clinical programming 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 programming needed for internal data exploration, data management, and regulatory submissions. Ensure high quality, compliant programming to produce the datasets, tables, and statistical analyses needed for regulatory compliant output 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. This role includes providing the vision for and overseeing the creation of standard statistical programming tools, common code (macros), and table/figure/listing layouts.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Supervision and management of statistical programming staff and contractors, including hiring, motivation, training, coaching/mentoring, and performance evaluation; Provide staff with reliable guidance to succeed and grow.
- Provide leadership, vision and support for the creation and validation of standard global SAS macros and utilities to automate standards and frequent tasks to enhance quality and efficiency.
- Oversee programming and validation of datasets, tables, listings, and graphics, and other submission deliverables from clinical and pre-clinical studies including define.xml, reviewer's guides, SDTM annotated CRFs, and computational methods documentation.
- Ensures compliance with CDISC standards for Study Data Tabulation Model (SDTM), Analysis
- Data Model (ADaM), Standard for the Exchange of Nonclinical Data (SEND).
- Ensuring QC of vendor programming deliverables.
- Ensuring the review of critical documents including protocols, CRFs, SAPs, mock TFLs, DMPs, Randomization Plans, DSMB / SMC charters, and CSRs.
- Ensuring the review of DTA/DTS specifications for external data transfers.
- Liaise between Biostatistics, Regulatory, and eCTD submission group for the preparation of module 5 materials, answering questions about the submission data standards, communicating with FDA experts, if necessary.
- Ensure the programming effort by working collaboratively with Biostatistics, Clinical Operations and Clinical Development, Data Management, and Regulatory to meet project deliverables and timelines for statistical data analysis and reporting for both in-house and outsourced projects.
- Review and monitor project timelines, adjusting, if necessary, to ensure project can meet both planned and unplanned needs in a timely way.
- Responsibility for programming SOPs and Guidelines development and revision.
- Update skills continually with respect to evolving industry standards, statistical concepts, regulatory expertise, and biological/therapeutic area knowledge.
- Provide input into Vendor selection and management, including writing RFPs, negotiating contracts and scopes of work.
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
- Master or Bachelor’s degree in Statistics, Computer Science, or related quantitative fields
- Over 10 years of experience in a pharmaceutical industry or other clinical research setting, with over 5 years in a supervisory/managerial capacity.
- Over five years of program management experience.
- Highly competent in SAS programming and Macro development; ability to understand the implementation of statistical analyses.
- High degree of technical competence.
- Thorough understanding of ICH Guidelines and relevant regulatory requirements.
- Pharmaceutical experience with clinical trials.
- Familiar with expectations of regulatory agencies, especially FDA and EMA. Experience with NDA/BLA or other regulatory filing, including ISS or ISE experience.
- In-depth knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidance documents.
- Experience with departmental resource allocation and labor requirement assessment.
- Excellent project management skills and ability to prioritize tasks.
- Excellent written, verbal, and interpersonal communication skills, and strong negotiation, and organizational skills
- Must be fluent in the English language.
- Ability to foster team productivity, cohesiveness, and collaboration. Leadership with strong results orientation.
- Must be able to work independently.
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.