Associate Director, Statistical Programming

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; BT5528, a BTC molecule targeting EphA2; 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 exploring the use of Bicycle technology to develop therapies for diseases beyond oncology.

The Associate Director, Statistical Programming will be accountable and responsible for leading statistical programming activities for multiple clinical studies, maintaining programming infrastructure and ensuring timely deliverables with high quality. You will perform oversight on the counterpart from vendors and report to the Senior Director, Statistical Programming. You should demonstrate leadership competencies and have extensive experience in SAS programming within biopharmaceutical clinical trials environment and in-depth understanding of CDISC standards and drug development principles in solid tumor therapeutic area.

• Collaborate closely with Biostatistics, Data Management, Medical, Safety, Clinical Research, Clinical Operation, and other functions within Bicycle Therapeutics to address their needs for statistical programming support.
• Develop and validate programming specifications for table, listing, and figure.
• Develop and validate SAS program that generates table, listing, and figure.
• Apply knowledge of CDISC SDTM and ADaM to develop and validate SDTM annotated CRF, SDTM mapping specification and ADaM specification.
• Develop and validate SAS program that generates SDTM and ADaM dataset.
• Create and validate files necessary to support electronic submission in eCTD format.
• Conduct statistical programming and/or statistical simulations to support clinical decision making, regulatory interaction, and publication.
• Support development of CRF, edit check, review of Data Transfer Specification, and any other collaborations with Data Management function.
• Effectively manage external vendors.

Qualifications:

• Good Clinical Practice (GCP) proficient.
• Broad and advanced knowledge of Biostatistics and relevant disciplines related to clinical development and clinical studies, preferably in Oncology therapeutic area.
• Proficient programming skills using SAS, with in-depth experience on BASE SAS, SAS/STAT, SAS Macro.
• Ability to independently manage multiple projects, strong problem-solving skills, and excellent teamwork spirit.
• Effective SAS techniques in efficacy and safety analysis of solid tumor clinical studies.
• 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.

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.