Associate Director, Biostatistics
3 months ago
Bicycle Therapeutics is a clinical-stage biopharmaceutical 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 BT8009, a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC 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, MA.
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.
The Associate Director of 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, you will provide key biostatistical input and quantitative deep thinking to support a wide variety of projects in clinical development. The Associate Director of Biostatistics will closely collaborate with partner functions such as Medical, Clinical Research, Clinical Operation, Data Management, Statistical Programming, etc. This position reports to the Director of Biostatistics.
The ideal candidate has demonstrated advanced expertise in Biostatistics, comprehensive working experience in clinical studies, preferably in Oncology therapeutic area, as well as strong leadership.
- Responsible for all biostatistical deliverables on project teams in multi-disciplinary interactions
- Serve as in house biostatistics point of contact at clinical study level, provide review and approval for statistical documents and other relevant study documents as needed, oversight vendor biostatistical work to ensure high quality.
- Provide statistical expertise to support protocol development, study set up and conducting; author or peer review Statistical Analysis Plan (SAP); review data specifications and TFL shell; provide statistical QC as needed; co-author or peer review clinical study report and publications.
- Provide support as needed to ensure efficient action, collaboration, and resolution of biostatistical issues.
- Conduct statistical analysis and/or statistical simulations to support clinical decision making
Essential:
- Ph.D degree in Statistics or Biostatistics with experience in the pharmaceutical or biotechnology industry
- Good Clinical Practice (GCP) proficient
- Advanced knowledge of Biostatistics related to clinical development and clinical studies.
Desirable:
- Proficient programming skills using R and SAS. In-depth experience on statistical simulations
- Ability to independently manage multiple projects, strong problem-solving skills, and excellent teamwork spirit
- Excellent communication skills, both written and verbal
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.
All your information will be kept confidential according to EEO guidelines.
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.
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