Principal Statistical Programmer

Intercept Pharmaceuticals, Inc.; United States; Remote; USD 145,000 - 165,000; Full time

Job summary

An established industry player is seeking a Principal Statistical Programmer to lead statistical programming efforts for clinical trials. This role involves developing and validating SAS programs, managing datasets, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in the biotechnology or pharmaceutical industry, with a strong background in SAS programming and statistical analysis. Join a passionate team dedicated to improving patients' lives through innovative liver disease therapies. This is a fantastic opportunity to contribute to meaningful work in a supportive and inclusive environment.

Benefits

401(k) plan with company match

Health care benefits

Paid Time Off program

Tuition reimbursement assistance

Short and long-term disability coverage

Paid parental leave benefits

Rewards and recognition program

Qualifications

• 6+ years in statistical programming within biotech/pharma/CRO.
• Extensive knowledge of SAS and programming standards required.

Responsibilities

• Manage statistical programming for clinical trials and regulatory submissions.
• Generate and validate datasets, tables, figures, and listings.

Skills

SAS Programming

Statistical Analysis

Project Management

Problem Solving

Interpersonal Skills

Leadership

Organizational Skills

Education

Bachelor’s degree in Statistics, Mathematics, Computer Science

Tools

SAS

R

Python

Spotfire

Job description

POSITION SUMMARY:

As Intercept continues to build its position as the leader in rare and serious liver disease, we are seeking a Principal Statistical Programmer. The Principal Statistical Programmer is responsible for supporting the statistical programming efforts for a compound program, including developing, testing, maintaining, validating, and documenting SAS programs. As part of the Statistical Programming team, this person will also provide technical expertise for the development of SAS programming standards and procedures.

JOB RESPONSIBILITIES:

1. Ensure departmental or functional training plans in place and appropriate
2. Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time deliverables within budget
3. Generate, validate, and/or review SDTM domains and ADaM datasets and associated specifications
4. Generate, validate, and/or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications
5. Generate or perform quality control for SAS programs and other study documents (e.g., presentations and reports)
6. Maintain complete and auditable documentation of all programming activities
7. Manage datasets and output across SAS programs, studies, and indications to ensure consistency
8. Manage and provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad-hoc requests
9. Manage programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures
10. Develop and/or maintain departmental procedures and standards
11. Review CRFs, edit check specifications, and table, figure, and listing mock-ups
12. Manage, generate, and/or review acrf.pdf, define.xml, define.pdf, and reviewer’s guide documents
13. Assist in validation of SAS per 21 CFR Part 11
14. Train and mentor new members and programmers; supervise contract programmers, as needed

QUALIFICATIONS:

1. Bachelor’s degree in Statistics, Mathematics, Computer Science or a related field required
2. Minimum of 6 years biotechnology/pharmaceutical/CRO industry experience as a statistical programmer
3. Prior experience overseeing statistical programming contractors required
4. Compound oversight experience highly preferred
5. Extensive knowledge of SAS Macros highly preferred, in addition to knowledge of Base SAS, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS
6. Experience working with other languages or software (R, Python, Spotfire) in validated environments is strongly preferred
7. Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines
8. eCTD NDA submission experience is a must

REQUIRED KNOWLEDGE AND ABILITIES:

1. Ability to travel up to 5% required, which may include overnight and/or weekend travel
2. Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
3. Exceptional interpersonal skills and problem-solving capabilities
4. Proven meeting planning skills
5. Ability to work effectively across a matrix organization
6. Ability to work independently and collaboratively
7. Ability to prioritize with minimal daily instruction
8. Ability to think strategically to improve current processes
9. Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner
10. Demonstrate excellent leadership skills within department; 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
11. Works effectively with cross functional groups, study team, and vendors
12. Adheres to departmental and regulatory agency procedures and standards
13. Strong verbal and written communications skills
14. Learning agility and ‘scalability’ to take on increasing responsibility as Intercept grows
15. Consistent demonstration and embodiment of our Corporate Beliefs: Passion for Innovation; Think Big, Act Small; Learn to Dare; and Teams Build the Future
16. Ability to have fun and thrive in a growing, diverse, and inclusive work environment

ABOUT INTERCEPT:

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, including primary biliary cholangitis (PBC) and severe alcohol-associated hepatitis (sAH). In a new age of liver disease treatment, our team is developing vital therapies to meet the needs of those living with rare and serious liver disease. We are committed to improving patients’ lives and addressing the liver community’s most pressing needs.

People at Intercept are passionate about patients. You’ll see our patient photos lining our walls and hear their stories in town halls. We’re equally passionate about our team, ensuring each member feels included and has the opportunity to reach their potential. We recognize the power of an equal opportunity work force, and how it enriches the professional lives of our team members. Equal opportunity drives innovation and connects us to the patients and communities we serve.

COMPENSATION & BENEFITS:

The anticipated salary range for this position is $145,000 to $165,000. This represents the anticipated low and high end of the salary range for this position. Actual salaries may vary based on various factors including, but not limited to, experience, skillset, and performance.

The salary range listed is just one component of our total compensation package. Intercept also provides a competitive suite of benefits, including:

• 401(k) plan with company match
• Rewards and recognition program
• Health care benefits (medical, prescription drugs, dental, and vision insurance)
• Short and long-term disability coverage provided
• Plan coverage for domestic partners
• Paid parental leave benefits and adoption assistance
• Tuition reimbursement assistance
• A generous Paid Time Off program that includes 20 vacation days, 11 holidays, 4 personal days, and 2 volunteer days per calendar year
• Numerous well-being and work/life programs

EEO Statement

Employment decisions at the Company are made without unlawful regard to race, color, religion, creed, national origin, alienage or citizenship status, sex (including gender, pregnancy, childbirth or medical conditions related to pregnancy or childbirth), gender identity or expression, sexual orientation, national origin, ethnicity, age, physical or mental disability, legally protected genetic information, marital or partnership status, sexual and reproductive health decisions, military or veteran status, or any other status protected by applicable federal, state, or local law. This organization participates in E-Verify (E-Verify's Right to Work guidance can be found here: https://www.e-verify.gov/sites/default/files/everify/posters/IER_RighttoWorkPoster.pdf).

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