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Senior Director, Statistical Programming

Job Description

COMPANY SUMMARY:

At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases. Intercept's lead product, obeticholic acid (OCA), is a first-in-class farnesoid X receptor (FXR) agonist marketed under the brand name \"Ocaliva ® \" in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva ® was the first medication to be approved for PBC in over twenty years, and sales continue to grow more than four years after its initial approval in 2016.

Intercept has also established the leading clinical development program in advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a disease that impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and the REGENERATE study of OCA remains the only Phase 3 trial to have generated positive results in the disease. A second Phase 3 trial, REVERSE, is evaluating OCA in patients with compensated cirrhosis due to NASH, with results expected in 2021.

People at Intercept are passionate about patients. You'll see their photos lining our walls and hear their stories in town halls. We're equally passionate about our team and ensuring each member reaches their potential. We brave new challenges together. That's how we find better ways to get things done and break down barriers. It's also how we make it fun to work here.

At Intercept, we foster an environment that celebrates creativity, collaboration and mutual respect. We never hesitate to lean on our teammates and work together. Our relatively small size means you partner with accessible leaders who know you by name. This brings accountability and growth, which all add up to more opportunities to learn something new every day. A strong commitment to diversity, equity and inclusion is engrained in both our culture and our business. For self-motivated leaders who are ready to make a di­fference in the lives of patients, Intercept is a great place to be.

POSITION SUMMARY:

As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking a Senior Director, Statistical Programming. This essential group head will be responsible for managing the statistical programming efforts for all projects and studies, including overseeing the developing, testing, maintaining, validating, and documenting SAS programs. As part of the Statistical Programming team, this person will also provide technical expertise to the development of SAS programming standards and procedures. The head of statistical programming will have responsibility and accountability of programming support as it relates to all stages of development for one or multiple therapeutic areas including the clinical-related components of regulatory submissions, either Clinical Trial Applications or New Drug Applications, to Post-marketing activities. This position may represent programming group on the clinical and project teams across the company's portfolio, providing subject matter expertise to the Clinical program. The position is expected to provide oversight and supervision of relevant external consultants; Supervise internal and external personnel to provide high quality programming support. The head of statistical programming is also expected to provide input for cross functional standardization and harmony, technology and process improvement and resource forecasting.

CORE ACCOUNTABILITIES:

The successful candidate must be able to perform each of the following satisfactorily:

  • Lead the team to ensure that resources (processes, procedures, personnel etc) optimally support the business requirements of the function.
  • Ensure that the department has a well-organized infrastructure and adequate resources to enable projects to be completed on time and within budget.
  • Provide accurate forecasting figures for the annual budgeting process and manage throughout the year to ensure that the budgetary goals are met or exceeded.
  • Undertake the full range of duties relevant to the leadership, management and development of the programming team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives.
  • Ensure departmental or functional training plans in place and appropriate.
  • Demonstrate excellent leadership skills within programming and BDM. This includes taking an active role in departmental and company activities (e.g., management meetings), ensuring employees adhere to corporate policies and following up with management as appropriate.
  • Train, coach and mentor new team members.
  • Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
  • Participate in formal staff review processes e.g. performance reviews to corporate standards and timescales.
  • Perform vendor qualifications in regards to statistical programming functions and manage CROs regarding programming issues and activities to ensure on time deliverables within budget.
  • Generate and/or validate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files.
  • Generate and/or validate tables, figures, and listings to support clinical trial statistical analyses for regulatory submissions and publications.
  • Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
  • Maintain complete and auditable documentation of all programming activities.
  • Review output across SAS programs to ensure consistency.
  • Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
  • Manage programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
  • Participate in the development and/or maintenance of departmental procedures and standards.
  • Works effectively with cross functional groups, study team, and vendors.
  • Facilitate and maintain communication between statistical programming and cross-functional areas including biostatistics, data management, Clinical Research, Clinical Operations, Regulatory Affairs and Operations, Pharmacovigilance, Medical Affairs, commercial, etc.
  • Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
  • Drive the spirit of \"ONE Team\" across all functions by supporting a team approach to focus on our patients and customers as our top priorities
  • Make Intercept a truly desired place to work



Experience and Skills

QUALIFICATIONS:

  • Master's degree in Statistics, Mathematics, or Computer Science or in a related field. Minimum of 15 years Biotechnology/Pharmaceutical/CRO industry experience as a statistical programmer.
  • Prior experience managing a statistical programming team required.
  • Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
  • Excellent communication and interpersonal skills to effectively interface with others.
  • eCTD NDA submission experience is a must


REQUIRED KNOWLEDGE AND ABILITIES:

  • Excellent organization and multi-tasking skills.
  • Exceptional interpersonal skills and problem solving capabilities.
  • Proven meeting planning skills.
  • Ability to work effectively across a matrix organization.
  • Ability to work independently, to negotiate and to prioritize crit
  • Ability to think strategically in order to improve current processes.
  • Extensive knowledge of GCP, ICH guidelines, FDA regulations, CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements; In-depth knowledge of the global drug development process.
  • Advanced understanding of the development, programming, management, validation and documentation maintenance of all programming tasks
  • Ability to lead a team with regards to ongoing development both personnel development and departmental methodologies and techniques.
  • Manage multiple programs with competing and aggressive timelines, prioritize activities, and work independently; Able to work in a quickly changing, not fully structured internal and external environment.
  • Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
  • Strong verbal and written communications skills
  • Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
  • Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
  • Ability to have fun and thrive in a growing, diverse and inclusive work environment



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Senior Director, Statistical Programming

New York, NY
Full Time

Published on 12/31/2021

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