Sr. Director, Statistical Programming

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/clinical programming and data standards strategy, oversight and guidance for research activities for all phases of Science and Development activities. Takes a lead role in liaising 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 activities are professionally led and represented both within and external to the company, providing support and expertise to members of the team. This role dives and leads the development and governance of biostatistics and data science standards (eg, analysis tools, common code (macros), and table/figure/listing layouts) and process strategies, provides leadership in data-driven centralized monitoring approaches, supports pharmacovigilance activities, and develops standards and processes for the integration of clinical data to support regulatory agency submissions and reporting requirements.

I. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• As a key Science and Development team member, establish, align and confirm statistical programming expectations for studies, through regular interaction with Clinical Operations, Clinical Data Management, Biostatistics, Quality Assurance, Regulatory, and Outsourcing.
• 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.
• Continually invest in team empowerment. Develop a clear vision and strategic direction, while also creating a culture around effective communication, a sense of urgency, and prioritizing collaboration with both internal and external partners.
• 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.
• Responsible for the development, maintenance, and strategy of end-to-end standards for collecting, reporting, and analysis of clinical data following industry models (including but not limited to: SDTM, Controlled Terminology, ADaM, TFLs, and questionnaires). This includes compliance, assessment, and decommissioning, as necessary.
• Is a Champion for and leads the development of strategies and governance for assessing, implementing maintenance, and integrating systems and tools to support, manage, govern, and report on data standards.
• Responsible for developing, implementing, and maintaining the structure, content, and processes for a clinical trial data repository and metadata repository.
• Ensuring QC of vendor programming deliverables.
• Ensuring the review of critical documents including protocols, CRFs, SAPs, mock TFLs, DMPs, Randomization Plans, DSMB / SMC charters, data review guidelines, metadata for CDISC SDTM and ADaM data, Analysis Results Metadata (ARM) 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, Regulatory and external vendors to meet project deliverables and timelines for statistical data analysis and reporting for both in-house and outsourced projects.
• Develops and implements a data-driven Risk Based Quality Management process to drive the new paradigm of managing risk for the entire clinical trial lifecycle in order to identify areas of greatest risk and implement targeted measures and controls to monitor and address the quality of the trial.
• Review and monitor project timelines, adjusting if necessary, to ensure project can meet both planned and unplanned needs in a timely way.
• Acts as a champion for change with the responsibility for programming SOPs and Guidelines, process maps, templates development and revision.
• Update skills continually with respect to evolving industry standards, statistical concepts, regulatory expertise, and biological/therapeutic area knowledge.
• Review the UAT Plan and testing of clinical study databases including the development of edit check specifications and manual data listings, as required.
• Ensures compliance with CDISC standards for Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), Standard for the Exchange of Nonclinical Data (SEND), as needed.
• 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.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Master or Bachelor's degree in Statistics, Computer Science, or related quantitative fields.
• MS 12+/BS 15+ years of experience in a pharmaceutical industry or other clinical research setting with outsourced CRO oversight experience.
• 10 years direct supervisory experience.
• Highly competent in SAS programming and Macro development; ability to understand the implementation of statistical analyses. High degree of technical competence and the ability to identify and communicate data trends.
• Critical thinker with great attention to detail.
• Thorough understanding of ICH Guidelines and relevant regulatory requirements.
• Pharmaceutical experience with clinical trials.
• NDA/BLA submission experience with expert knowledge of regulatory and clinical study data submission requirements for FDA, EMA, and ROW (Rest of the World) and solid understanding of ICH, GCP, 21 CFR Part 11 required.
• Familiarity with ICH-E6 (R2) required; experience with centralized (data-driven) monitoring and oversight preferred.
• In-depth knowledge of CDISC STDM and ADaM specifications and associated regulatory guidance documents.
• Experience with departmental resource allocation and labor requirement assessment.
• Excellent project management skills, ability to lead and facilitate meetings, ability to prioritize tasks and adapt flexibility to changing priorities.
• Excellent written, verbal, and interpersonal communication skills with the ability to simply summarize complex information, and strong negotiation, and organizational skills.
• Ability to foster team productivity, cohesiveness, and collaboration. Leadership with strong results orientation.
• Demonstrated success record of working in a matrixed environment and regularly collaborating with cross-functional teams, such as clinical trial operations, biometrics, pharmacovigilance, IT, business-led technology organizations, and external vendors.
• Must be able to work independently as well as part of a team.

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.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder no matter what
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • Every person at Emergent is engaged and accountable for delivering on our commitments.
• Break through thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.