What are the responsibilities and job description for the Manager, Biostatistics position at Bicycle Therapeutics?
Company Description
Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radio Conjugates (BRC™) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology.
Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Massachusetts US.
Culture is key and all Bicycle employees actively embrace and role model our company values:
- We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients.
- We are Dedicated to our Mission. You can’t change the world if you don’t have determination.
- We are One Team. We only succeed when we work together.
Job Description
The Manager, Biostatistics will be a key member of the Biometrics function with accountability for biostatistical activities in Bicycle clinical studies. In addition to the oversight on Biostatistics counterpart from vendors, he/she will provide key biostatistical input and quantitative deep thinking to support a wide variety of projects in clinical development. The Senior manager of Biostatistics will closely collaborate with partner functions such as Medical, Clinical Science, Clinical Operation, Data Management, Statistical Programming, etc. This position reports to Senior Director, Biostatistics.
The ideal candidate has a demonstrated good understanding of statistical analysis and clinical trial design, proficient programming skills using R and SAS, as well as excellent communication skills.
- Serves as study biostatistician in the cross-functional teams for the clinical trial planning, execution, and reporting
- Provide oversight of outsourced biostatistical activities under supervision, including protocol development, case report form (CRF) development, statistical analysis plan (SAP) and table, figure, and listing (TFL) shells, SDTM and ADaM dataset specifications review development for interim and final analyses
- Coordinate with other functional areas, and management of timelines relating to key milestones and ensuring outsourced work is performed with high quality; provide statistical QC as needed
- Provide inputs on study related reports and ensure the accuracy, including clinical study reports (CSRs) and safety reporting etc.
- Provide statistical programming support (SAS and R) to internal ad-hoc requests/analyses
- Provide support as needed (technical, clinical) to ensure efficient action, collaboration and resolution of biostatistical issues
Qualifications
- Ph.D. degree in Statistics or Biostatistics
- Proficient programming skills using R and SAS
- In-depth experience on statistical simulations
- Good understanding of statistical analysis and clinical trial design
- Ability to show strong problem-solving skills, and work effectively with personnel with different functional background
- Excellent communication skills, both written and verbal
- Demonstrated motivation, the ability to learn, and consistently focus on details and execution
Additional Information
- Flexible working environment
- Competitive reward including annual company bonus
- Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company
- Health and Dependent Care Flexible Spending Accounts
- 401(k) plan with a 4% Company match and immediate vesting
- Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days
- Employee assistance program
- Employee recognition schemes
- 10 Company holidays
- Competitive Family Leave Policy
- Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.
