Senior Manager, Statistical Programming

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Cambridge, MA.

Culture is key and all Bicycle employees actively embrace and role model our company values:

WeareAdventurous.We believe it’sthewaytodeliverextraordinaryresultsforourpatients.

WeareDedicatedtoourMission.Youcan’tchangetheworldifyoudon’thavedetermination.

WeareOneTeam.Weonlysucceedwhenweworktogether.

Job Description

The Senior Manager Statistical Programming will act as statistical programming lead for various clinical studies. You will collaborate with Biostatisticians and Statistical Programmers and ensure high quality and timely statistical programming deliverables. You also will perform oversight on the counterpart from vendors. You will report to 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, preferably 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 specification for table, listing, and figure

Develop and validate SAS program that generate 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 generate 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

Qualifications

Essential:

Good Clinical Practice (GCP) proficient

Broad and advanced knowledge of Biostatistics and relevant disciplines related to clinical development and clinical studies, preferably in solid tumor therapeutic area

Proficient programming skills using SAS. In-depth experience on BASE SAS, SAS/STAT, SAS Macro

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.