Senior Director, Statistical Methodologist
BiogenSalary not specified
Full Time
Senior (5 to 8 years)
Senior Manager, Statistical Programming at Tango Therapeutics
Boston, Massachusetts, United States
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Precision OncologyIndustries
Requirements
- Bachelor’s or master’s degree in statistics, life sciences, computer science, or related field with at least 8 years’ statistical programming experience
- Experience in oncology preferred
- Solid understanding of industry standards applicable to clinical study data and regulatory reporting requirements including eCTD and CDISC implementation
- Expert level in SAS programming (Base, Macro, STAT, GRAPH, SQL) is essential; with experience delivering complex programming assignments, macros, and analyses
- Experience with R is desirable
- Extensive experience in clinical studies including programming and validation of SDTM and ADaM data sets, tables, listings and figures
- Expertise in the requirements and technology to support electronic submissions
- Experience with BLA, NDA/sNDA submissions to FDA/EMA preferred
- Strong analytical and communication skills
Responsibilities
- Lead the statistical programming activities for clinical trials and studies, ensuring high-quality and timely deliverables for CSR, publications, presentations, various reports for health authority submissions, clinical data review, and ad hoc analysis
- Develop, validate, and maintain analysis datasets (SDTM, ADaM), tables, listings, and figures (TLFs) in accordance with regulatory guidelines and internal standards
- Review key clinical study or program documents
- Perform complex statistical analyses and simulations using SAS or R to support clinical trial design and data interpretation; manage macro library and templates for efficiently preparing, processing, analyzing clinical data and validating analysis results
- Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD)
- Collaborate with biostatisticians, data managers, and cross-functional team members to define programming strategies and requirements, establish project timelines, and perform statistical analyses
- Author or review SDTM and ADaM specifications to ensure compliance with CDISC standards
- Develop SAS or R code, manage macro or utilities library and templates for efficiently preparing, processing, analyzing clinical data, and validating analysis results
- Author and review statistical analysis related SOPs
- Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis
- Additional duties and responsibilities as required
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What experience is required for the Senior Manager, Statistical Programming role?
A Bachelor’s or master’s degree in statistics, life sciences, computer science, or related field with at least 8 years’ statistical programming experience is required, with oncology experience preferred.
What programming languages or tools are needed for this position?
Proficiency in SAS or R is required for performing complex statistical analyses, simulations, developing code, and managing macro libraries and templates.
Is this a remote position or does it require working in an office?
The job is based in the Tango labs and offices located at 201 Brookline Avenue in the Fenway area of Boston, Massachusetts, suggesting an on-site requirement.
What is the salary or compensation for this role?
This information is not specified in the job description.
What makes a strong candidate for this Senior Manager role?
Strong candidates will have 8+ years of statistical programming experience in clinical trials, expertise in SAS or R, knowledge of CDISC standards like SDTM and ADaM, and experience with oncology and regulatory submissions.
Tango Therapeutics
Develops targeted cancer therapies using synthetic lethality
About Tango Therapeutics
Tango Therapeutics develops targeted cancer treatments using the principle of synthetic lethality, which allows them to design drugs that kill cancer cells while leaving healthy cells unharmed. Their approach focuses on the interaction between genes, where the loss of both genes leads to cell death, but the loss of only one does not. This method enables them to create therapies that are more precise in targeting tumors. Tango operates in the oncology market, primarily serving healthcare providers and pharmaceutical companies interested in advanced cancer therapies. They collaborate with larger pharmaceutical firms, like Gilead Sciences, to co-develop their treatments, which helps in funding and speeding up the process of bringing these drugs to market. Tango's goal is to advance their pipeline of targeted immunotherapies through strong research and development efforts and strategic partnerships.
Cambridge, MassachusettsHeadquarters
2017Year Founded
$341.4MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
51-200Employees