Senior Manager, Statistical Programming
PTC Therapeutics, Inc.
Summary
The Senior Manager, Statistical Programming performs the programming activities for clinical development programs and associated clinical studies either directly or through Contract Research Organization (CRO) oversight. Participates in the development of new and review of existing statistical programming standard operating procedures and processes and biostatistics computing systems implementations and application development as appropriate.
Job description
The incumbent works cross-functionally with internal departments and external resources on statistical programming related issues.
The Senior Manager, Statistical Programming supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Essential Functions
- Leads the statistical programming activities for assigned clinical development studies and programs.
- Ensures timely statistical analyses of clinical data per protocols and Statistical Analysis Plans; either directly or through CRO oversight develops statistical programs and produces programmed outputs used to create integrated scientific reports for clinical trial results.
- Participates in study team meetings as a representative of the Biostatistics function. Communicates statistical issues and acts as a statistical/programming resource to the development teams.
- Participates in the assessment, selection and evaluation of CROs.
- Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Action Plans, TLGs and TLG shells.
- Interacts with CROs involved in data management/analysis activities to ensure that their statistical analyses and resulting outputs are accurate and consistent with the contractually agreed upon deliverables; works with vendor staff to characterize and resolve issues related to data analysis.
- Creates/Reviews derived dataset specifications and the related analysis datasets.
- May develop SOPs and training guidelines related to statistical programming.
- Performs other tasks and assignments as needed and specified by management.
Knowledge/Skills/Abilities Required
- Master’s degree in a quantitative science discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 5 years of experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment.
- Demonstrated and applied SAS programming skills (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) and a good understanding of database systems.
- Working knowledge of R
- Clinical Data Interchange Standards Consortium (CDISC) experience
- Knowledge of clinical data analysis and reporting process as it relates to drug development.
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Preferred Qualifications
- Experience working with CROs.
- Experience supporting New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs) submissions.
Travel requirements: Up to 20%
Requirements
- Master’s degree in a quantitative science discipline (e.g., Statistics, Mathematics, Computer Science)
- Minimum of 5 years of experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment
- Demonstrated and applied SAS programming skills (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS)
- Good understanding of database systems
- Working knowledge of R
- Clinical Data Interchange Standards Consortium (CDISC) experience
- Knowledge of clinical data analysis and reporting process as it relates to drug development
- Excellent verbal and written communication and skills
- Ability to work independently and collaboratively in a fast-paced, matrixed, team environment
- Analytical thinker with excellent problem-solving skills
- Excellent planning, organization and time management skills
- Experience working with CROs
- Experience supporting New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs) submissions
Benefits
- Medical, Dental & Vision
- Retirement Savings Plans
- Short-term Incentives
- Long-term Incentives
Company overview
PTC Therapeutics, Inc. is a patient-centered biopharmaceutical company founded in 1998 and headquartered in Warren, New Jersey. The company specializes in discovering, developing, and commercializing innovative medicines for children and adults living with rare and serious diseases. PTC focuses on orally administered small molecule drugs and gene therapies that regulate gene expression by targeting post-transcriptional control mechanisms. The company's therapeutic areas include orphan and ultra-orphan disorders, oncology, and anti-infectives, with a particular emphasis on genetic disorders affecting metabolism and neurology. PTC's commercialized products include treatments for Duchenne muscular dystrophy, aromatic L-amino acid decarboxylase deficiency, spinal muscular atrophy, and other rare conditions. The company operates globally with a dedicated team of approximately 939 employees and maintains a robust pipeline of investigational therapies. PTC is publicly traded on NASDAQ under the symbol PTCT and has established itself as a leader in rare disease therapeutics through its commitment to scientific innovation and patient-focused approach.