Director of Statistical Programming

The Company:
We are Larimar Therapeutics, based in the Philadelphia area, and committed to discovering and developing therapeutics to dramatically improve the lives of patients with complex rare diseases. At Larimar, we embrace everyone's contribution to our Mission. Our values connect us and ensure we communicate openly, treat each other with respect, help us grow from our successes and failures, and innovate. If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you!
We are a clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, CTI-1601, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality.
We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and about 40 employees. Our management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs and the development of manufacturing processes utilizing good manufacturing practices (GMPs).
Our strategy is to become a leader in the treatment of rare diseases by leveraging our technology platform and applying the team's know how and expertise to the development of CTI-1601 and other future pipeline programs.
The Opportunity:
As the Director, Statistical Programming you will lead the Statistical Programming function for our clinical development programs at Larimar, contributing to the vision, direction, and strategy of the Statistical Programming function and of Statistical and Quantitative Sciences (SQS) as a whole. You'll build strong collaboration with clinical development and study teams to identify and meet their needs for Statistical Programming support.
Role and Responsibility:

• Collaborate with the IT team to build and maintain secure statistical computing environment and programming infrastructure.
• Hands-on Statistical Programming for CSR, publications, presentations, DSUR, IB, safety data review, and ad hoc analyses
• Lead the Statistical Programming activities for regulatory submissions following CDISC standards.
• Collaborate with the study statistician and study team in project planning
• Review key study-related documents including but not limited to SAP, CRFs and data management plan
• Author SDTM and ADAM specifications in collaboration with the study statistician
• Effectively manage the CRO to ensure high-quality deliverables within timeline and budget
• Validate/QC key TFLs generated by the CRO
• Responsible for one or more studies with concurrent tasks and timelines
• Creates departmental SOPs and other processes to conform with industry and regulatory requirements.
• Creates data collection and reporting standards within and across programs that conform with industry and regulatory requirements (e.g., CDASH, STDM, ADaM).
• Understands regulatory requirements concerning industry technical standards (e.g., CDISC standards, 21 CFR Part 11, FDA requirements, electronic submission standards, etc.) and implications for the department.
• Collaborates cross-functionally to resolve departmental issues and ensure effective communication throughout the drug development process.
• Develops and maintains programming infrastructure to support SQS activities.
• Responsible for recruiting, mentoring, and developing Statistical Programming staff members.
• Provides leadership/expertise for day-to-day Statistical Programming tasks in support of ongoing projects.

Requirements

• Bachelor's degree or higher in Mathematics, Statistics, Computer Science, or a related field.
• 10+ years Statistical Programming experience in biotech/pharmaceutical industry
• Experience in managing the Statistical Programming team
• Extensive experience of leading both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings
• Expert level SAS programmer with experience in delivering complex programming assignments, macros and analyses
• Experience with Neurology trials is preferred
• Experience with R is a plus
• Experience with BLA or NDA/sNDA to FDA/EMA is preferred. Experience with other major global health authority submission is a plus
• Experience in management of CROs with respect to Statistical Programming
• Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization

We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.
Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.