Job Information
Mallinckrodt Pharmaceuticals Senior Director, Biometrics in Bridgewater, New Jersey
Job Title
Senior Director, Biometrics
Requisition
JR000013560 Senior Director, Biometrics (Open)
Location
US Specialty Brand Headquarters - USA501
Additional Locations
Bridgewater, NJ
Job Description
The Senior Director, Biometrics is a key leadership role within the Evidence Generation & Data Sciences (EGDS) department. The Sr Dir, Biometrics is responsible for overseeing three important functions: biostatistics, clinical and statistical programming, and data management. The Sr Dir, Biometrics ensures accurate analysis and management of data from clinical trials and research studies. The Sr Dir, Biometrics heads a group of data experts, offers strategic direction to ensure top-notch outcomes and adherence to regulatory standards, and holds a pivotal position in guaranteeing the precision, reliability, and punctual provision of clinical trial information and statistical assessments.
Principal Responsibilities and Key Requirements
Biostatistics: Provide strategic direction and guidance for biostatistics activities throughout the organization; ensure design and implementation of appropriate statistical methods for clinical trials and research studies; oversee development of statistical analysis plans and generation of statistical outputs for regulatory submissions; collaborate with cross-functional teams to interpret and communicate statistical results to support decision-making.
Clinical and Statistical Programming: Lead and manage the clinical and statistical programming team responsible for developing, validating, and maintaining programs for data analysis and reporting; ensure adherence to programming standards and best practices, including efficient programming techniques and automation; collaborate with statisticians and other stakeholders to define programming requirements and deliverables; provide guidance on innovative programming techniques and emerging technologies to enhance efficiency and quality.
Data Management: Provide strategic oversight of data management activities, ensuring the collection, storage, and cleaning of high-quality clinical trial data; develop and implement data management standards and procedures in compliance with regulatory guidelines and industry best practices; collaborate with cross-functional teams to ensure timely database lock and availability of clean and accurate data for analysis; oversee the selection and management of external vendors and contractors for data management activities.
Continuously advances the group's operational efficiency through process redesign, continuous quality initiatives, benchmarking, productivity studies, the development of clinical and management information systems and the introduction of new technologies.
Plays a leadership role within R&D and other functional groups as needed to ensure the successful planning and execution of R&D programs.
Minimum Requirements:
Master’s or doctorate degree in Biostatistics, Statistics, or related field
12+ years of relevant experience in biostatistics, statistical programming, and data management roles, with progressively increasing responsibilities; experience in the pharmaceutical or medical device industry is highly desirable.
3+ years supervisory experience with strong leadership skills and the ability motivate a team of professionals
Experience working with regulatory authorities (EMEA, FDA, etc).
Strong knowledge of statistical principles and methodologies applied to clinical trials and research studies
In-depth understanding of regulatory requirements, including relevant industry guidelines and standards
Proficiency in statistical software packages (e.g., SAS, R) and programming languages commonly used
Demonstrated experience in leading biostatistics, statistical programming, and data management teams
Excellent communication skills, with ability to communicate complex scientific concepts to diverse stakeholders
Strong problem-solving and decision-making abilities, with focus on delivering high-quality results within timelines.
Excellent organizational and project management skills, with the ability to prioritize tasks, meet deadlines, and manages budgets effectively.
Organizational Relationship/Scope:
The Senior Director, Biometrics reports directly to the VP, Evidence Generation & Data Sciences (EGDS). This role will partner with and positively influence other R&D colleagues including Clinical Development & Medical Affairs, Research & Development Operations, Evidence Generation & Data Sciences, Regulatory Affairs & Pharmacovigilance, and Program Management; Marketing, Market Access, Commercial Effectiveness, Communications, Legal, Healthcare Compliance, Procurement, Finance, and other departments. Engages with Management to influence decisions.
Working Conditions:
Position can be remote or hybrid.
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Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.
Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.